Professional Documents
Culture Documents
PAREXEL International: Dataset Specification
PAREXEL International: Dataset Specification
PAREXEL International: Dataset Specification
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
VISITNUM Visit Number Num 8 Topic Req
VISIT Visit Name Char 40 Synonym Qualifier Perm
VISITDY Planned Study Day of Visit Num 8 Timing Perm
SVSTDTC Start Date/Time of Visit Char 19 ISO 8601 Timing Exp
SVENDTC End Date/Time of Visit Char 19 ISO 8601 Timing Exp
SVSTDY Study Day of Start of Visit Num Timing Perm
SVENDY Study Day of End of Visit Num Timing Perm
SVUPDES Description of Unplanned Visit Char Synonym Qualifier Perm
*Sort order - STUDYID,USUBJID,VISITNUM,SVSTDTC
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 1 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 2 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
AESEQ Sequence Number Num 8 Identifier Req
AEGRPID Group ID Char Identifier Perm
AEREFID Reference ID Char Identifier Perm
AESPID Sponsor-Defined Identifier Char Identifier Perm
AETERM Reported Term for the Adverse Event Char 200 Topic Req
AEMODIFY Modified Reported Term Char Synonym Qualifier Perm
AELLT Lowest Level Term Char 200 Variable Qualifier Exp
AELLTCD Lowest Level Term Code Num 8 Variable Qualifier Exp
AEDECOD Dictionary-Derived Term Char 200 Synonym Qualifier Req
AEPTCD Preferred Term Code Num 8 Variable Qualifier Exp
AEHLT High Level Term Char 200 Variable Qualifier Exp
AEHLTCD High Level Term Code Num 8 Variable Qualifier Exp
AEHLGT High Level Group Term Char 200 Variable Qualifier Exp
AEHLGTCD High Level Group Term Code Num 8 Variable Qualifier Exp
AECAT Category for Adverse Event Char Grouping Qualifier Perm
AESCAT Subcategory for Adverse Event Char Record Qualifier Perm
AEPRESP Pre-Specified Adverse Event Char (NY) Record Qualifier Perm
AEBODSYS Body System or Organ Class Char 200 Variable Qualifier Exp
AEBDSYCD Body System or Organ Class Code Num 8 Variable Qualifier Exp
AESOC Primary System Organ Class Char 200 Variable Qualifier Exp
AESOCCD Primary System Organ Class Code Num 8 Record Qualifier Exp
AELOC Location of Event Char (LOC) Record Qualifier Perm
AESEV Severity/Intensity Char 50 (AESEV) Record Qualifier Perm
AESER Serious Event Char 3 (NY) Record Qualifier Exp
AEACN Action Taken with Study Treatment Char 50 (ACN) Record Qualifier Exp
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 3 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 4 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 5 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 6 of 194
PAREXEL International
Dataset Specification
Source Dataset: AE
Target Source eCRF: Adverse Event
VAR NAME LABEL TYPE LENGTH FORMAT CORE DEFAULT VALUE NOTES
STUDYID Study Identifier Char 11 Req "AN-SLE3331"
RDOMAIN Related Domain Abbreviation Char 2 Req "AE"
USUBJID Unique Subject Identifier Char 20 Req
IDVAR Identifying Variable Char 8 Exp
IDVARVAL Identifying Variable Value Char 10 Exp
QNAM Qualifier Variable Name Char 8 Req
QLABEL Qualifier Variable Label Char 40 Req
QVAL Data Value Char 200 Req
QORIG Origin Char 20 Req
QEVAL Evaluator Char 50 Exp
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 7 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 8 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE SOURCE DATASET
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
20
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 9 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 10 of 194
PAREXEL International
AESER
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 11 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 12 of 194
PAREXEL International
Dataset Specification
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 13 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE
STUDYID Study Identifier text
DOMAIN Domain Abbreviation text
USUBJID Unique Subject Identifier text
SESEQ Sequence Number integer
ETCD Element Code text
ELEMENT Description of Element text
SESTDTC Start Date/Time of Element text
SEENDTC End Date/Time of Element text
TAETORD Project Role: Data Transfer SAS Programmer (mandatory) integer
EPOCH Epoch text
SEUPDES Project Role: Statistical SAS Programmer (if applicable) text
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 14 of 194
PAREXEL International
SUBJECT ELEMENTS
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 15 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 16 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 17 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 18 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
SCSEQ Sequence Number Num 8 Identifier Req
SCGRPID Group ID Char Identifier Perm
SCSPID Sponsor-Defined Identifier Char Identifier Perm
SCTESTCD Subject Characteristic Short Name Char 8 (SCCD) Topic Req
SCTEST Subject Characteristic Char 40 Synonym Qualifier Req
SCCAT Category for Subject Characteristic Char Grouping Qualifier Perm
SCSCAT Subcategory for Subject Characteristic Char Grouping Qualifier Perm
SCORRES Result or Finding in Original Units Char 20 Result Qualifier Exp
SCORRESU Original Units Char (UNIT) Variable Qualifier Perm
SCSTRESC Character Result/Finding in Std Format Char 20 Result Qualifier Exp
SCSTRESN Numeric Result/Finding in Standard Uni Num Result Qualifier Perm
SCSTRESU Standard Units Char (UNIT) Variable Qualifier Perm
SCSTAT Completion Status Char (ND) Record Qualifier Perm
SCREASND Reason Not Performed Char Record Qualifier Perm
SCDTC Date/Time of Collection Char ISO 8601 Timing Perm
SCDY Study Day of Examination Num Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 19 of 194
PAREXEL International
Source Dataset: DM
Source eCRF: Demography
NOTES
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 20 of 194
PAREXEL International
Dataset Specification
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 21 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
MHSEQ Sequence Number Num 8 Identifier Req
MHGRPID Group ID Char Identifier Perm
MHREFID Reference ID Char Identifier Perm
MHSPID Sponsor-Defined Identifier Char Identifier Perm
MHTERM Reported Term for the Medical History Char 200 Topic Req
MHMODIFY Modified Reported Term Char Synonym Qualifier Perm
MHDECOD Dictionary-Derived Term Char 200 Synonym Qualifier Perm
MHCAT Category for Medical History Char 80 Grouping Qualifier Perm
MHSCAT Subcategory for Medical History Char 80 Grouping Qualifier Perm
MHPRESP Medical History Event Pre-Specified Char (NY) Record Qualifier Perm
MHOCCUR Medical History Occurrence Char 1 (NY) Record Qualifier Perm
MHSTAT Completion Status Char (ND) Record Qualifier Perm
MHREASND Reason Medical History Not Collected Char Record Qualifier Perm
MHBODSYS Body System or Organ Class Char 200 Record Qualifier Perm
MHDTC Date/Time of History Collection Char 19 ISO 8601 Timing Perm
MHSTDTC Start Date/Time of Medical History Event Char 19 ISO 8601 Timing Perm
MHENDTC End Date/Time of Medical History Event Char 19 ISO 8601 Timing Perm
MHDY Study Day of History Collection Num Timing Perm
MHENRF End Relative to Reference Period Char 30 (STENRF) Timing Perm
MHENRTPT End Relative to Reference Time Point Char Timing Perm
MHENTPT End Reference Time Point Char Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 22 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 23 of 194
PAREXEL International
Dataset Specification
Source Dataset: MH
Target Source eCRF: Medical History
VAR NAME LABEL TYPE LENGTH FORMAT CORE DEFAULT VALUE NOTES
STUDYID Study Identifier Char 11 Req "AN-SLE3331"
RDOMAIN Related Domain Abbreviation Char 2 Req "MH"
USUBJID Unique Subject Identifier Char 20 Req
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 24 of 194
PAREXEL International
substr(cats("AN-
SLE3331-",upcase(PATID)),1,17)
MHSEQ
Value of MHSEQ for related record
MHPTC
Ptcode
Value of "itmPTcode" for related record
ASSIGNED
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 25 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 26 of 194
PAREXEL International
substr(cats("AN- substr(cats("AN-
SLE3331-",upcase(PATID)),1,17) SLE3331-",upcase(PATID)),1,17)
MHSEQ MHSEQ
Value of MHSEQ for related record Value of MHSEQ for related record
MHHLGTC MHSOCTC
HLGTcode SOCcode
Value of "itmHLGTcode" for related record Value of "itmSOCcode" for related record
ASSIGNED ASSIGNED
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 27 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
LBSEQ Sequence Number Num 8 Identifier Req
LBGRPID Group ID Char Identifier Perm
LBREFID Specimen ID Char Identifier Perm
LBSPID Sponsor-Defined Identifier Char Identifier Perm
LBTESTCD Lab Test or Examination Short Name Char 8 (LBTESTCD) Topic Req
LBTEST Lab Test or Examination Name Char 40 (LBTEST) Synonym Qualifier Req
LBCAT Category for Lab Test Char 80 Grouping Qualifier Exp
LBSCAT Subcategory for Lab Test Char 80 Grouping Qualifier Perm
LBORRES Result or Finding in Original Units Char 200 Result Qualifier Exp
LBORRESU Original Units Char 40 (UNIT) Variable Qualifier Exp
LBORNRLO Reference Range Lower Limit in Orig Unit Char 40 Variable Qualifier Exp
LBORNRHI Reference Range Upper Limit in Orig Unit Char 40 Variable Qualifier Exp
LBSTRESC Character Result/Finding in Std Format Char 200 Result Qualifier Exp
LBSTRESN Numeric Result/Finding in Standard Units Num 8 Result Qualifier Exp
LBSTRESU Standard Units Char 40 (UNIT) Variable Qualifier Exp
LBSTNRLO Reference Range Lower Limit-Std Units Num 8 Variable Qualifier Exp
LBSTNRHI Reference Range Upper Limit-Std Units Num 8 Variable Qualifier Exp
LBSTNRC Reference Range for Char Rslt-Std Units Char Variable Qualifier Perm
LBNRIND Reference Range Indicator Char 30 Variable Qualifier Exp
LBSTAT Completion Status Char 8 (ND) Record Qualifier Perm
LBREASND Reason Test Not Done Char Record Qualifier Perm
LBNAM Vendor Name Char Record Qualifier Perm
LBLOINC LOINC Code Char Synonym Qualifier Perm
LBSPEC Specimen Type Char 40 Record Qualifier Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 28 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 29 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 30 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 31 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 32 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 33 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 34 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 35 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 36 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 37 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 38 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 39 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 40 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 41 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 42 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 43 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
VSSEQ Sequence Number Num 8 Identifier Req
VSGRPID Group ID Char Identifier Perm
VSSPID Sponsor-Defined Identifier Char Identifier Perm
VSTESTCD Vital Signs Test Short Name Char 8 (VSTESTCD) Topic Req
VSTEST Vital Signs Test Name Char 40 (VSTEST) Synonym Qualifier Req
VSCAT Category for Vital Signs Char 80 Grouping Qualifier Perm
VSSCAT Subcategory for Vital Signs Char 80 Grouping Qualifier Perm
VSPOS Vital Signs Position of Subject Char (POSITION) Record Qualifier Perm
VSORRES Result or Finding in Original Units Char 200 Result Qualifier Exp
VSORRESU Original Units Char 40 (VSRESU) Variable Qualifier Exp
VSSTRESC Character Result/Finding in Std Format Char 200 Result Qualifier Exp
VSSTRESN Numeric Result/Finding in Standard Units Num 8 Result Qualifier Exp
VSSTRESU Standard Units Char 40 (VSRESU) Variable Qualifier Exp
VSSTAT Completion Status Char 8 (ND) Record Qualifier Perm
VSREASND Reason Not Performed Char Record Qualifier Perm
VSLOC Location of Vital Signs Measurement Char (LOC) Record Qualifier Perm
VSBLFL Baseline Flag Char 1 (NY) Record Qualifier Exp
VSDRVFL Derived Flag Char (NY) Record Qualifier Perm
VISITNUM Visit Number Num 8 Timing Exp
VISIT Visit Name Char 40 Timing Perm
VISITDY Planned Study Day of Visit Num 8 Timing Perm
VSDTC Date/Time of Measurements Char 19 ISO 8601 Timing Exp
VSDY Study Day of Vital Signs Num Timing Perm
VSTPT Planned Time Point Name Char Timing Perm
VSTPTNUM Planned Time Point Number Num Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 44 of 194
PAREXEL International
VSELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm
VSTPTREF Time Point Reference Char Timing Perm
VSRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 45 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 46 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 47 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
IESEQ Sequence Number Num 8 Identifier Req
IESPID Sponsor-Defined Identifier Char Identifier Perm
IETESTCD Inclusion/Exclusion Criterion Short Name Char 8 Topic Req
IETEST Inclusion/Exclusion Criterion Char 200 Synonym Qualifier Req
IECAT Inclusion/Exclusion Category Char 80 (IECAT) Grouping Qualifier Req
IESCAT Inclusion/Exclusion Subcategory Char Grouping Qualifier Perm
IEORRES I/E Criterion Original Result Char 1 (NY) Result Qualifier Req
IESTRESC I/E Criterion Result in Std Format Char 1 (NY) Result Qualifier Req
VISITNUM Visit Number Num 8 Timing Perm
VISIT Visit Name Char 40 Timing Perm
VISITDY Planned Study Day of Visit Num 8 Timing Perm
IEDTC Date/Time of Collection Char ISO 8601 Timing Perm
IEDY Study Day of Collection Num Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 48 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 49 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
EXSEQ Sequence Number Num 8 Identifier Req
EXGRPID Group ID Char Identifier Perm
EXSPID Sponsor-Defined Identifier Char Identifier Perm
EXTRT Name of Actual Treatment Char 200 Topic Req
EXCAT Category for Treatment Char 80 Grouping Qualifier Perm
EXSCAT Subcategory for Treatment Char Grouping Qualifier Perm
EXDOSE Dose per Administration Num 8 Record Qualifier Exp
EXDOSTXT Dose Description Char Record Qualifier Perm
EXDOSU Dose Units Char 40 (UNIT) Variable Qualifier Exp
EXDOSFRM Dose Form Char 40 (FRM) Variable Qualifier Exp
EXDOSFRQ Dosing Frequency per Interval Char 40 (FREQ) Variable Qualifier Perm
EXDOSTOT Total Daily Dose Num Record Qualifier Perm
EXDOSRGM Intended Dose Regimen Char Variable Qualifier Perm
EXROUTE Route of Administration Char (ROUTE) Variable Qualifier Perm
EXLOT Lot Number Char Record Qualifier Perm
EXLOC Location of Dose Administration Char (LOC) Record Qualifier Perm
EXTRTV Treatment Vehicle Char 10 Record Qualifier Perm
EXVAMT Treatment Vehicle Amount Num 5 Variable Qualifier Perm
EXVAMTU Treatment Vehicle Amount Units Char 40 (UNIT) Variable Qualifier Perm
EXADJ Reason for Dose Adjustment Char Record Qualifier Perm
TAETORD Planned Order of Element within Arm Num Timing Perm
EPOCH Epoch Char Timing Perm
EXSTDTC Start Date/Time of Treatment Char 19 ISO 8601 Timing Exp
EXENDTC End Date/Time of Treatment Char ISO 8601 Timing Perm
EXSTDY Study Day of Start of Treatment Num Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 50 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 51 of 194
PAREXEL International
Source Dataset: EX
Source eCRF: Study Drug Administration
NOTES
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 52 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 53 of 194
PAREXEL International
Dataset Specification
Source Dataset: EX
Target Source eCRF: Study Drug Administration
VAR NAME LABEL TYPE LENGTH FORMAT CORE DEFAULT VALUE NOTES
STUDYID Study Identifier Char 11 Req "AN-SLE3331"
RDOMAIN Related Domain Abbreviation Char 2 Req "EX"
USUBJID Unique Subject Identifier Char 20 Req
IDVAR Identifying Variable Char 8 Exp
IDVARVAL Identifying Variable Value Char 10 Exp
QNAM Qualifier Variable Name Char 8 Req
QLABEL Qualifier Variable Label Char 40 Req
QVAL Data Value Char 200 Req
QORIG Origin Char 20 Req
QEVAL Evaluator Char 50 Exp
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 54 of 194
PAREXEL International
Source Dataset: EX
Source eCRF: Study Drug Administration
NOTES
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 55 of 194
PAREXEL International
Dataset Specification
Target
VAR NAME LABEL TYPE LENGTH FORMAT ROLE CORE DEFAULT VALUE
STUDYID Study Identifier Char 11 Identifier Req
DOMAIN Domain Abbreviation Char 2 Identifier Req
USUBJID Unique Subject Identifier Char 20 Identifier Req
CMSEQ Sequence Number Num 8 Identifier Req
CMGRPID Group ID Char Identifier Perm
CMSPID Sponsor-Defined Identifier Char Identifier Perm
CMTRT Reported Name of Drug, Med, or Therapy Char 200 Topic Req
CMMODIFY Modified Reported Name Char Synonym Qualifier Perm
CMDECOD Standardized Medication Name Char 200 Synonym Qualifier Perm
CMCAT Category for Medication Char 80 Grouping Qualifier Perm
CMSCAT Subcategory for Medication Char Grouping Qualifier Perm
CMPRESP CM Pre-Specified Char (NY) Record Qualifier Perm
CMOCCUR CM Occurrence Char (NY) Record Qualifier Perm
CMSTAT Completion Status Char (ND) Record Qualifier Perm
CMREASND Reason Medication Not Collected Char Record Qualifier Perm
CMINDC Indication Char 200 Record Qualifier Perm
CMCLAS Medication Class Char 200 Variable Qualifier Perm
CMCLASCD Medication Class Code Char 8 Variable Qualifier Perm
CMDOSE Dose per Administration Num 8 Record Qualifier Perm
CMDOSTXT Dose Description Char Record Qualifier Perm
CMDOSU Dose Units Char 40 (UNIT) Variable Qualifier Perm
CMDOSFRM Dose Form Char (FRM) Variable Qualifier Perm
CMDOSFRQ Dosing Frequency per Interval Char 50 (FREQ) Variable Qualifier Perm
CMDOSTOT Total Daily Dose Num Record Qualifier Perm
CMDOSRGM Intended Dose Regimen Char Variable Qualifier Perm
CMROUTE Route of Administration Char 40 (ROUTE) Variable Qualifier Perm
CMSTDTC Start Date/Time of Medication Char 19 ISO 8601 Timing Perm
CMENDTC End Date/Time of Medication Char 19 ISO 8601 Timing Perm
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 56 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 57 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 58 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 59 of 194
PAREXEL International
Dataset Specification
Source Dataset: CM
Target Source eCRF: Concomitant Medications
VAR NAME LABEL TYPE LENGTH FORMAT CORE DEFAULT VALUE NOTES
STUDYID Study Identifier Char 11 Req
RDOMAIN Related Domain Abbreviation Char 2 Req
USUBJID Unique Subject Identifier Char 20 Req
IDVAR Identifying Variable Char 8 Exp
IDVARVAL Identifying Variable Value Char 10 Exp
QNAM Qualifier Variable Name Char 8 Req
QLABEL Qualifier Variable Label Char 40 Req
QVAL Data Value Char 200 Req
QORIG Origin Char 20 Req
QEVAL Evaluator Char 50 Exp
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 60 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 61 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 62 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 63 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 64 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 65 of 194
PAREXEL International
Dataset Specification
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 67 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 68 of 194
PAREXEL International
ROLE LENGTH
Identifier 11
Identifier 2
Topic 8
Synonym Qualifier 200
Grouping Qualifier 80
Grouping Qualifier 80
Rule 200
Record Qualifier 40
INCLUSION
INCLUSION
INCLUSION
EXCLUSION
EXCLUSION
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 69 of 194
PAREXEL International
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 70 of 194
PAREXEL International
EXCLUSION
EXCLUSION
EXCLUSION
EXCLUSION
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 71 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 72 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 73 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 74 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 75 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 76 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 77 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 78 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 79 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 80 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 81 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 82 of 194
PAREXEL International
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
C71620 Unit
Not Done
C66789 Not Done
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 83 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 84 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 85 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 86 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 87 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 88 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 89 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 90 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 91 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 92 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 93 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 94 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 95 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 96 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 97 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 98 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 99 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 100 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 101 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 102 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 103 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 104 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 105 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 106 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 107 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 108 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 109 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 110 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 111 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 112 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 113 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 114 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 115 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 116 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 117 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 118 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 119 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 120 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 121 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 122 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 123 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 124 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 125 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 126 of 194
PAREXEL International
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 127 of 194
PAREXEL International
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
C71113 Frequency
Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
C66729 Route of Administration
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 128 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 129 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 130 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 131 of 194
PAREXEL International
HOURS Hour; hr
% Percentage
mm Millimeter
kg Kilogram
mg Milligram
mL Milliliter; cm3
WEEKS Week
MONTHS Month
YEARS Year
m Meter
msec Millisecond
sec Second
amp Ampere
cd Candela
mol Mole
Hz Hertz
Newton Newton
Pa Pascal
Joule Joule
Watt Watt
Coulomb Coulomb
V Volt
Farad Farad
Sv Sievert
ohm Ohm
Siemens Siemens
Weber Weber; V*sec; Volt Second; Volt-second
Tesla Tesla
Henry Henry
C Degree Celsius
lm Lumen
lx Lux
Bq Becquerel
kat Katal
m2 Square Meter
m3 Cubic Meter
m/sec Meter Per Second
g/L g/L; Gram per Liter; kg/m3; Kilogram per
Cubic Metre; Microgram per Microliter;
Milligram per Milliliter; ug/uL; mg/mL
F Degree Fahrenheit
pH pH
ug Microgram; mcg
min Minute Unit of Time
g Gram
cm2 Square Centimeter
ft2 Square Foot
Ci Curie
AMPULE Ampule Dosing Unit
BAG Bag Dosing Unit
BAR Bar Dosing Unit
BOLUS Bolus Dosing Unit
BOTTLE Bottle Dosing Unit
BOX Box Dosing Unit
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 132 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 133 of 194
PAREXEL International
IU International Unit
QUANTITY SUFFICIENT Quantity Sufficient
cm Centimeter
mmHg Millimeter of Mercury; torr; Torr
kg/m2 Kilogram per Square Meter
BEATS/MIN Beats per Minute
BREATHS/MIN Breaths per Minute
CUP Cup Dosing Unit
atm Atmosphere
RING Ring Dosing Unit
mmol/L Millimole per Liter; umol/mL; Micromole per
Milliliter; mol/m3; Mole per Cubic Meter;
mcmol/mL; mmol/L; nmol/uL
pg Picogram
fg Femtogram
ag Attogram
cg Centigram
dram Dram
kg/L Kilogram per Liter; g/mL; Gram per Milliliter;
gram/mL; kg/L; mg/uL
mg/L g/m3; Gram per Cubic Meter; mg/L;
Microgram per Milliliter; Milligram per Liter;
mcg/mL; ng/uL; ug/mL
mL/min Milliliters per Minute
g/dL Gram per Deciliter; g%
pmol Picomole
PUFF Puff
mm2 Square Millimeter
tuberculin unit Tuberculin Unit
mL/h Milliliters per Hour
per sec Per Second
per min Per Minute
mg/h Milligram per Hour
mg/dL Milligram per Deciliter; mg%
cal Calorie
kcal Kilogram-Calorie
PFU Plaque Forming Unit
eq Equivalent Weight
HPF High Power Field
g/m2 Gram per Square Meter
ug/L mg/m3; Microgram per Liter; Milligram per
Cubic Meter; Nanogram per Milliliter; ug/L;
ng/mL; mcg/L
LPF Low Power Field
mV Millivolt
ng/dL Nanogram per Deciliter
ng/L ug/m3; Microgram per Cubic Meter; ng/L;
pg/mL
nm Nanometer
osm Osmole
psi Pounds per Square Inch
10^6 IU Million International Units; Million IU
nCi Nanocurie
IU/L International Unit per Liter; IU/L; mIU/mL
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 134 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 135 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 136 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 137 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 138 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 139 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 140 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 141 of 194
PAREXEL International
kPa/L/sec Pa/mL/sec
ks Kilosecond; 10^3 sec; ksec
L/h/m2 Liters per Hour per Square Meter
L/L Liter per Liter; mL/mL; uL/uL; dL/dL
L/min/m2 Liters per Minute per Square Meter
mEq/g Creatinine
mg/g Creatinine
mL/cm Milliliter per Centimeter; dL/m
mL/dL Milliliters per Deciliter
mL/min/mmHg Milliliter per Minute per Torr
mL/sec/1.73m2
mm/2h Millimeters per Two Hours
mm/min Millimeters per Minute
mm/sec Millimeters per Second
mmHg/L/min
mmol/g Creatinine
mmol/mol Creatinine
mph Miles per Hour
mV*min Millivolt * Minutes
nU/cL Nanounit per Centiliter
PA Per Annum; Per Year; Every Year
pt_br Imperial Pint; British Pint
pt_us US Pint
titer
U/cL Unit per Centiliter
U/dL Unit per Deciliter
U/g Creatinine
U/g HGB Units per Gram Hemoglobin
ug/g Creatinine
ugEq Microgram Equivalent
umol/L/sec Micromoles per Liter per Second
uV*sec Microvolt * Seconds
V/sec Volt per Second; V/s
Frames/s Frames/sec; Frames per Second; FPS; F/s
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 142 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 143 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 144 of 194
PAREXEL International
CD4 CD4
CD8 CD8
DOHLE Dohle Bodies
ESR Erythrocyte Sedimentation Rate; Biernacki
Reaction
HYPSEGCE Hypersegmented Cells
LYMMCE Lymphoma Cells
MAYHEG May-Hegglin Anomaly
METAMY Metamyelocytes
PAPPEN Pappenheimer Bodies
PELGERH Pelger Huet Anomaly
LYMPL Plasmacytoid Lymphocytes; Plymphocytes
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 145 of 194
PAREXEL International
SPERM Spermatozoa
YEAST Yeast Cells
CYAMORPH Amorphous Crystals
AMORPHSD Amorphous Sediment; Amorphous Debris
BICARB Bicarbonate; HCO3
CYBILI Bilirubin Crystals
CYCACAR Calcium Carbonate Crystals
CYCAOXA Calcium Oxalate Crystals
CYCAPHOS Calcium Phosphate Crystals
CYCHOL Cholesterol Crystals
CRYSTALS Crystals
CYCYSTIN Cystine Crystals
VITB9 Folic Acid; Vitamin B9
CARNITF Carnitine, Free
FRUCT Fructosamine; Glycated Serum Protein
IRON Iron; FE
CYLEUC Leucine Crystals
CYMSU Monosodium Urate Crystals
CARNIT Carnitine
CYTYRO Tyrosine Crystals
CYURIAC Uric Acid Crystals
ANIONG Anion Gap
OCCBLD Occult Blood
AMPHET Amphetamine
BARB Barbiturates
CANNAB Cannabinoids
COCAINE Cocaine
EPIROCE Round Epithelial Cells
ACANT Acanthocytes
BITECE Bite Cells
BURRCE Burr Cells; Keratocytes
CABOT Cabot Rings
CRENCE Crenated Cells; Echinocytes
HOWJOL Howell-Jolly Bodies
RBCNUC Nucleated Erythrocytes; Nucleated Red
Blood Cells
SCHISTO Schistocytes
SPHERO Spherocytes
STOMCY Stomatocytes
HEINZ Heinz Bodies; Heinz-Erhlich Bodies
HAAB Hepatitis A Virus Antibody
HBSAB Anti-HBs; HBsAb; Hepatitis B Virus Surface
Antibody
HCAB Hepatitis C Virus Antibody
HIV1AB HIV-1 Antibody
HIV12AB HIV-1/2 Antibody
HIV2AB HIV-2 Antibody
RPR Rapid Plasma Reagin
RF Rheumatoid Factor
IBCT Total Iron Binding Capacity
IBCU Unsaturated Iron Binding Capacity
MUCTHR Mucous Threads
TURB Turbidity
HAVVLD HAV Viral Load
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 146 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 147 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 148 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 149 of 194
PAREXEL International
INTLK28 Interleukin 28
INTLK29 Interleukin 29
INTLK3 Interleukin 3
INTLK30 Interleukin 30
INTLK31 Interleukin 31
INTLK32 Interleukin 32
INTLK33 Interleukin 33
INTLK4 Interleukin 4
INTLK5 Interleukin 5
INTLK6 Interleukin 6
INTLK7 Interleukin 7
INTLK8 Interleukin 8
INTLK9 Interleukin 9
LDH1 LDH Isoenzyme 1
LDH2 LDH Isoenzyme 2
LDH3 LDH Isoenzyme 3
LDH4 LDH Isoenzyme 4
LDH5 LDH Isoenzyme 5
LDHCREAT Lactate Dehydrogenase/Creatinine
LACTICAC Lactic Acid; 2-hydroxypropanoic acid; Lactate
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 150 of 194
PAREXEL International
SECRETIN Secretin
SRTONIN Serotonin
NACREAT Sodium/Creatinine
SDH Sorbitol Dehydrogenase
THRMPTN Thrombopoietin
TRH Thyrotropin Releasing Hormone; Thyrotropin
Releasing Factor
VMA Vanillyl Mandelic Acid; Vanilmandelic Acid
VITA Vitamin A; Retinol
VITB1 Thiamine; Vitamin B1
VITB17 Vitamin B17; Amygdalin
VITB2 Riboflavin; Vitamin B2
VITB3 Niacin; Vitamin B3
VITB5 Vitamin B5; Pantothenic Acid
VITB6 Vitamin B6; Pyridoxine
VITB7 Vitamin B7; Biotin
VITC Vitamin C; Ascorbic Acid
VITD2 Vitamin D2; Ergocalciferol
VITD3 Vitamin D3; Cholecalciferol
VITE Vitamin E
VITK Vitamin K; Naphthoquinone
VOLUME Volume
A1ANTRYP Alpha-1 Antitrypsin; Serum Trypsin Inhibitor
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 151 of 194
PAREXEL International
C3 Complement C3
C3A Complement C3a; ASP, Complement C3
DesArg, Acetylation-stimulating Protein
C3B Complement C3b
C4 Complement C4
C4A Complement C4a
C5A Complement C5a
CA125AG Cancer Antigen 125
CA19_9AG Cancer Antigen 19-9
CAION Calcium, Ionized
CALPRO Calprotectin
CBB Complement Bb
CD40 CD40
CD40L CD40 Ligand
CEA Carcinoembryonic Antigen
CHOLHDL Cholesterol/HDL-Cholesterol
CTOT Complement Total
CTXI Type I Collagen C-Telopeptides; Type I
Collagen X-linked C-telopeptide
CTXII Type II Collagen C-Telopeptides
CYSTARCH Starch Crystals
DDIMER D-Dimer
DNAAB Anti-DNA Antibodies; Anti-ds-DNA
Antibodies
EGF Epidermal Growth Factor
ELA1 Pancreatic Elastase 1
ELA1PMN Pancreatic Elastase 1, Polymorphonuclear
ELA2 Neutrophil Elastase
ELA2PMN Neutrophil Elastase, Polymorphonuclear
ENA78 Epith Neutrophil-Activating Peptide 78
ENDOTH1 Endothelin-1
ENRAGE Extracell Newly Ident RAGE Bind Protein;
S100 Calcium Binding Protein A12
EOSMM Eosinophilic Metamyelocytes
EOSMYL Eosinophilic Myelocytes
EOTAXIN1 Eotaxin-1; Chemokine Ligand 11
EOTAXIN2 Eotaxin-2; Chemokine Ligand 24
EOTAXIN3 Eotaxin-3; Chemokine Ligand 26
ESTRIOLF Estriol, Free
FABP1 Fatty Acid Binding Protein 1
FACTIII Factor III; Tissue Factor, CD142
FACTVII Factor VII; Proconvertin; Stable Factor
FACTVIII Factor VIII; Anti-hemophilic Factor
FATACFR Free Fatty Acid; Non-Esterified Fatty Acid,
Free
FATACFRS Free Fatty Acid, Saturated; Non-esterified
Fatty Acid, Saturated
FATACFRU Free Fatty Acid, Unsaturated; Non-esterified
Fatty Acid, Unsaturated
FATBODOV Fat Bodies, Oval
FDP Fibrin Degradation Products
FGFBF Fibroblast Growth Factor Basic Form; FGF2
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 152 of 194
PAREXEL International
GOLD Gold
GST Glutathione S-Transferase, Total
GSTALCRT Glutathione S-Transferase, Alpha/Creat
GSTPI Glutathione S-Transferase, Pi
GSTTH Glutathione S-Transferase, Theta
GUSA Glucuronidase, Alpha
GUSB Glucuronidase, Beta
HDL2 HDL-Cholesterol Subclass 2
HDL3 HDL-Cholesterol Subclass 3
HISTAMIN Histamine
HTPHAB Heterophile Antibodies
HYPRLN Hydroxyproline
IC512AB Islet Cell 512 Antibody
IC512AG Islet Cell 512 Antigen
IFNA Interferon Alpha
IFNB Interferon Beta
IFNG Interferon Gamma
IGA Immunoglobulin A
IGE Immunoglobulin E
IGG Immunoglobulin G
IGM Immunoglobulin M
INDICAN Indican
INGAPAB Islet Neogenesis Assoc Protein Antibody
INHIBINA Inhibin A
ISOPRF2 F2-Isoprostane
LPA Lipoprotein-a
LTF Lactoferrin; Lactotransferrin
LYMPHOTC Lymphotactin; Chemokine Ligand 1
MCP1 Monocyte Chemotactic Protein 1
MCSF Macrophage Colony Stimulating Factor
MDC Macrophage-Derived Chemokine;
Chemokine Ligand 22
MIP1A Macrophage Inflammatory Protein 1 Alpha;
Chemokine Ligand 3
MIP1B Macrophage Inflammatory Protein 1 Beta;
Chemokine Ligand 4
MMP1 Matrix Metalloproteinase 1; Interstitial
Collagenase
MMP2 Matrix Metalloproteinase 2; Gelatinase A
MMP3 Matrix Metalloproteinase 3; Stromelysin 1
MMP7 Matrix Metalloproteinase 7; Matrilysin
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 153 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 154 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 155 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 156 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 157 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 158 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 159 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 160 of 194
PAREXEL International
HYDROGEN Hydrogen
IRF Immature Reticulocyte Fraction
APTTLAS Lupus Anticoagulant Sensitive APTT; APTT-
LA
BLSTLY Lymphoblasts
METHAMPH Methamphetamine
P50OXYGN P50 Oxygen
IL2SRA Soluble Interleukin 2 Receptor Activity
SPERMMTL Sperm Motility
CONDUCTU Urine Conductivity
TXB2_D11 11-Dehydro-Thromboxane B2
DOPAC 3,4-Dihydroxyphenylacetic Acid
MDMA 3,4-methylenedioxymethamphetamine;
Ecstasy
ACT Activated Clot Time; Activated Clotting Time;
Coagulation Activated
ALBPROT Albumin/Total Protein
ALTCPHRL Alpha Tocopherol
ATPVITE Vitamin E Alpha Tocopherol
APLSMA2 Alpha-2 Plasmin Inhibitor
AMYLB38 Amyloid Beta 38; Amyloid Beta 38 Protein;
Amyloid Beta 1-38
AMYLB40 Amyloid Beta 40; Amyloid Beta 40 Protein;
Amyloid Beta 1-40
ANGLBIND Antiglobulin Test, Indirect; Indirect Coombs
Test
APOA4 Apolipoprotein A4
APOA5 Apolipoprotein A5
APOBAPA1 Apolipoprotein B/Apolipoprotein A1
CATNINB Beta Catenin
B2G1GGAB Beta-2 Glycoprotein 1 IgG Antibody
B2G1GMAB Beta-2 Glycoprotein 1 IgM Antibody
CAPHOSPD Calcium - Phosphorus Product
CA1AG Cancer Antigen 1
CA15_3AG Cancer Antigen 15-3
CRDIGMAB Cardiolipin IgM Antibody
CD1 CD1
CD14 CD14
CD2 CD2
CD2LY CD2/Lymphocytes
CD20 CD20
CD5 CD5
CD56 CD56
CETPA Cholesteryl Ester Transfer Protein Act
CDFTXN Clostridium difficile Toxin
CTTIGGAB Clostridium tetani IgG Antibody
COL4 Collagen Type IV
DRVVTRT Lupus Anticoagulant Ratio
DPPIVA DPPIV Activity
DPTIGGAB Diphtheria IgG Antibody
FACTIXA Christmas Factor Activity
FACTVA Labile Factor Activity
FACTVIIA Proconvertin Activity; Stable Factor Activity
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 161 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 162 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 163 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 164 of 194
PAREXEL International
Myeloblasts/Leukocytes Myeloblasts/Leukocytes
Myelocytes/Leukocytes Myelocytes/Leukocytes
Neutrophils/Leukocytes Neutrophils/Leukocytes
Reticulocytes/Erythrocytes Reticulocytes/Erythrocytes
Prolymphocytes/Leukocytes Prolymphocytes/Leukocytes
Neutrophils Band Form Neutrophils Band Form
Neutrophils Band Form/Leukocytes Neutrophils Band Form/Leukocytes
Specific Gravity Specific Gravity
Magnesium Magnesium
Gamma Glutamyl Transferase Gamma Glutamyl Transferase
Hemoglobin Hemoglobin
Hemoglobin A1C Hemoglobin A1C
Hepatitis B Virus Surface Antigen HBsAg; Hepatitis B Virus Surface Antigen
Choriogonadotropin Beta Choriogonadotropin Beta; Pregnancy Test
Potassium Potassium
Ketones Ketones
Lactate Dehydrogenase Lactate Dehydrogenase
Leukocyte Esterase Leukocyte Esterase
Phosphate Phosphate; Phosphorus; Inorganic
Phosphate
Protein Protein
Prostate Specific Antigen Prostate Specific Antigen
Creatinine Clearance Creatinine Clearance
Hairy Cells Hairy Cells
Blasts Blasts
CD19 CD19
CD3 CD3
CD4 CD4
CD8 CD8
Dohle Bodies Dohle Bodies
Erythrocyte Sedimentation Rate Erythrocyte Sedimentation Rate; Biernacki
Reaction
Hypersegmented Cells Hypersegmented Cells
Lymphoma Cells Lymphoma Cells
May-Hegglin Anomaly May-Hegglin Anomaly
Metamyelocytes Metamyelocytes
Pappenheimer Bodies Pappenheimer Bodies
Pelger Huet Anomaly Pelger Huet Anomaly
Plasmacytoid Lymphocytes Plasmacytoid Lymphocytes; Plymphocytes
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 165 of 194
PAREXEL International
CD19/Lymphocytes CD19/Lymphocytes
CD3/Lymphocytes CD3/Lymphocytes
CD4/CD8 CD4/CD8
CD4/Lymphocytes CD4/Lymphocytes
CD8/Lymphocytes CD8/Lymphocytes
Hairy Cells/Lymphocytes Hairy Cells/Lymphocytes
Leukemic Blasts/Lymphocytes Leukemic Blasts/Lymphocytes
Malignant Cells, NOS/Blood Cells Malignant Cells, NOS/Blood Cells
Metamyelocytes/Leukocytes Metamyelocytes/Leukocytes
Monoblasts/Leukocytes Monoblasts/Leukocytes
Nucleated Erythrocytes/Erythrocytes Nucleated Erythrocytes/Erythrocytes;
Nucleated Red Blood Cells/Erythrocytes
Plasmacytoid Lymphocytes/Lymphocytes Plasmacytoid Lymphocytes/Lymphocytes
Poikilocytes/Erythrocytes Poikilocytes/Erythrocytes
Precursor Plasma Cells/Lymphocytes Precursor Plasma Cells/Lymphocytes
Prolymphocytes/Lymphocytes Prolymphocytes/Lymphocytes
Promonocytes/Leukocytes Promonocytes/Leukocytes
Promyelocytes/Leukocytes Promyelocytes/Leukocytes
Reactive Lymphocytes/Lymphocytes Reactive Lymphocytes/Lymphocytes
Sezary Cells/Lymphocytes Sezary Cells/Lymphocytes
Sickle Cells/Erythrocytes Sickle Cells/Erythrocytes
Auer Rods Auer Rods
Helmet Cells Helmet Cells
Large Unstained Cells Large Unstained Cells
Malignant Cells, NOS Malignant Cells, NOS
Mature Plasma Cells Mature Plasma Cells; Plasmacytes
Myelocytes Myelocytes
Spermatozoa Spermatozoa
Yeast Cells Yeast Cells
Amorphous Crystals Amorphous Crystals
Amorphous Sediment Amorphous Sediment; Amorphous Debris
Bicarbonate Bicarbonate; HCO3
Bilirubin Crystals Bilirubin Crystals
Calcium Carbonate Crystals Calcium Carbonate Crystals
Calcium Oxalate Crystals Calcium Oxalate Crystals
Calcium Phosphate Crystals Calcium Phosphate Crystals
Cholesterol Crystals Cholesterol Crystals
Crystals Crystals
Cystine Crystals Cystine Crystals
Vitamin B9 Folic Acid; Vitamin B9
Carnitine, Free Carnitine, Free
Fructosamine Fructosamine; Glycated Serum Protein
Iron Iron; FE
Leucine Crystals Leucine Crystals
Monosodium Urate Crystals Monosodium Urate Crystals
Carnitine Carnitine
Tyrosine Crystals Tyrosine Crystals
Uric Acid Crystals Uric Acid Crystals
Anion Gap Anion Gap
Occult Blood Occult Blood
Amphetamine Amphetamine
Barbiturates Barbiturates
Cannabinoids Cannabinoids
Cocaine Cocaine
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 166 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 167 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 168 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 169 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 170 of 194
PAREXEL International
Leptin Leptin
Magnesium/Creatinine Magnesium/Creatinine
Melatonin Melatonin
Methadone Methadone
Methaqualone Methaqualone
Morphine Morphine
Mu Glutathione-S-Transferase Mu Glutathione-S-Transferase
Mu Glutathione-S-Transferase/Creatinine Mu Glutathione-S-Transferase/Creatinine
Myoglobin Myoglobin
N-Acetyl Glucosamide N-Acetyl Glucosamide; N-Acetyl
Glucosamine
N-Acetyl Glucosamide/Creatinine N-Acetyl Glucosamide/Creatinine
Neuropeptide Y Neuropeptide Y
Norepinephrine Noradrenaline; Norepinephrine
Osmolality Osmolality
Oxycodone Oxycodone; Oxycontin
Oxytocin Oxytocin; Oxytoxin
Phencyclidine Phencyclidine; Phenylcyclohexylpiperidine
Phenothiazine Phenothiazine; Dibenzothiazine
Phosphate/Creatinine Phosphate/Creatinine
Potassium/Creatinine Potassium/Creatinine
Prolactin Prolactin
Propoxyphene Propoxyphene
Protein/Creatinine Protein/Creatinine
Pseudoephedrine Pseudoephedrine
Reactive Lymphocytes Reactive Lymphocytes
Renin Renin; Angiotensinogenase
Secretin Secretin
Serotonin Serotonin
Sodium/Creatinine Sodium/Creatinine
Sorbitol Dehydrogenase Sorbitol Dehydrogenase
Thrombopoietin Thrombopoietin
Thyrotropin Releasing Hormone Thyrotropin Releasing Hormone; Thyrotropin
Releasing Factor
Vanillyl Mandelic Acid Vanillyl Mandelic Acid; Vanilmandelic Acid
Vitamin A Vitamin A; Retinol
Thiamine Thiamine; Vitamin B1
Vitamin B17 Vitamin B17; Amygdalin
Riboflavin Riboflavin; Vitamin B2
Niacin Niacin; Vitamin B3
Vitamin B5 Vitamin B5; Pantothenic Acid
Vitamin B6 Vitamin B6; Pyridoxine
Vitamin B7 Vitamin B7; Biotin
Vitamin C Vitamin C; Ascorbic Acid
Vitamin D2 Vitamin D2; Ergocalciferol
Vitamin D3 Vitamin D3; Cholecalciferol
Vitamin E Vitamin E
Vitamin K Vitamin K; Naphthoquinone
Volume Volume
Alpha-1 Antitrypsin Alpha-1 Antitrypsin; Serum Trypsin Inhibitor
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 171 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 172 of 194
PAREXEL International
Gold Gold
Glutathione S-Transferase, Total Glutathione S-Transferase, Total
Glutathione S-Transferase, Alpha/Creat Glutathione S-Transferase, Alpha/Creat
Glutathione S-Transferase, Pi Glutathione S-Transferase, Pi
Glutathione S-Transferase, Theta Glutathione S-Transferase, Theta
Glucuronidase, Alpha Glucuronidase, Alpha
Glucuronidase, Beta Glucuronidase, Beta
HDL-Cholesterol Subclass 2 HDL-Cholesterol Subclass 2
HDL-Cholesterol Subclass 3 HDL-Cholesterol Subclass 3
Histamine Histamine
Heterophile Antibodies Heterophile Antibodies
Hydroxyproline Hydroxyproline
Islet Cell 512 Antibody Islet Cell 512 Antibody
Islet Cell 512 Antigen Islet Cell 512 Antigen
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 173 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 174 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 175 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 176 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 177 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 178 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 179 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 180 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 181 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 182 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 183 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 184 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 185 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 186 of 194
PAREXEL International
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 187 of 194
PAREXEL International
INTRAMEDULLARY
INTRAMENINGEAL
INTRAMUSCULAR
INTRAOCULAR
INTRAOVARIAN
INTRAPERICARDIAL
INTRAPERITONEAL
INTRAPLEURAL
INTRAPROSTATIC
INTRAPULMONARY
INTRASINAL
INTRASPINAL
INTRASYNOVIAL
INTRATENDINOUS
INTRATESTICULAR
INTRATHECAL
INTRATHORACIC
INTRATUBULAR
INTRATUMOR Intratumor Route of Administration
INTRATYMPANIC
INTRAUTERINE
INTRAVASCULAR
INTRAVENOUS
INTRAVENOUS BOLUS
INTRAVENOUS DRIP
INTRAVENTRICULAR
INTRAVESICAL
INTRAVITREAL
IONTOPHORESIS
IRRIGATION
LARYNGEAL
NASAL Intranasal Route of Administration
NASOGASTRIC
NOT APPLICABLE
OCCLUSIVE DRESSING TECHNIQUE
OPHTHALMIC
ORAL PO; Intraoral Route of Administration
OROPHARYNGEAL
OTHER
PARENTERAL
PERCUTANEOUS
PERIARTICULAR
PERIDURAL
PERINEURAL
PERIODONTAL
RECTAL
RESPIRATORY (INHALATION)
RETROBULBAR
SOFT TISSUE
SUBARACHNOID
SUBCONJUNCTIVAL
SUBCUTANEOUS SC
SUBLINGUAL
SUBMUCOSAL
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 188 of 194
PAREXEL International
TOPICAL TOP
TRANSDERMAL
TRANSMUCOSAL
TRANSPLACENTAL
TRANSTRACHEAL
TRANSTYMPANIC
UNASSIGNED
UNKNOWN
URETERAL
URETHRAL
VAGINAL
DIETARY
ORAL GAVAGE
INTRASTOMAL
INTRAJEJUNAL
INTRAPALATAL
OROMUCOSAL
INTRACAMERAL
SUBTENON
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 189 of 194
PAREXEL International
Code List Data Entry Prefix Code Label (In order of appearance)
RACE [Blank]
RACE Black / African American
RACE White / Caucasian
RACE Asian / S.E. Asian Decent
RACE Native Hawaiian / Other Pacific Islander
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 190 of 194
PAREXEL International
Code Value
1
2
3
4
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 191 of 194
PAREXEL International
Decode Value
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 192 of 194
PAREXEL International
Target Source
EPOCH VISIT VISITNUM EvtOrder EvtLbl
SCREENING Screening 10 10.0 Screening (Day -28 to 0)
RANDOMIZATION Day 1 20 20.0 Day 1
TREATMENT Day 8 30 30.0 Day 8
TREATMENT Week 4 40 40.0 Week 4
TREATMENT Week 7 50 50.0 Week 7
TREATMENT Week 8 60 60.0 Week 8
TREATMENT Week 12 70 70.0 Week 12
TREATMENT Week 16 80 80.0 Week 16
TREATMENT Week 20 90 90.0 Week 20
TREATMENT Week 24 100 100.0 Week 24
TREATMENT Week 28 110 110.0 Week 28
TREATMENT Week 32 120 120.0 Week 32
TREATMENT Week 36 130 130.0 Week 36
TREATMENT Week 40 140 140.0 Week 40
TREATMENT Week 44 150 150.0 Week 44
TREATMENT Week 48 160 160.0 Week 48
TREATMENT Week 52 170 170.0 Week 52
TREATMENT End of Study 180 180.0 End of Study (Discontinuation)
TREATMENT End of Study 180 190.0 End of Study (Complete)
TREATMENT Protocol Deviation 210 210.0 Protocol Deviation
TREATMENT Unscheduled Increment Previous Evtorder Unscheduled
scheduled visit num with
0 0.1
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 193 of 194
PAREXEL International
Source
Notes
;.
FM-GRO-WW-246-06 Confidential
Effective Date: 14 Jun 12 Project Version Number:2.0
Related to: SOP-GRO-WW-024 Project Effective Date: Date of Signature
Page 194 of 194