Study Conduct

DM Bootcamp Presentation

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AGENDA

• Roles, Workflows & Reports

• Local Lab Listing Design, Develop &
QC
• External Data Design, Develop & QC
• External Data Reconciliation

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Qualio Documents to Review and
Reference as Part of this Training
1. FORM-71 DM Study Conduct Checklist
2. TEMP-87 Project RACI
3. Temp-38 Clean Patient Tracker (CPT)
4. Temp-40 Primary Information Grid (PIG)
5. TEMP-41 Local Lab Listing Specification
6. TEMP-56 External Vendor Change Request
7. FORM-67 - Data Transfer Agreement Template
8. TEMP-67 Data Integration Specification Template
9. TEMP-75 Data Management Report
10. PMSOP-1 Project Management
11. DSWI-4 External Data Design Develop QC Work Instruction
12. FORM-58 FTP Account Administration Form
13. TEMP-78 External Vendor Reconciliation Specifications 3
STUDY
CONDUCT
ROLES,
WORKFLOWS &
REPORTS
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DM Study
Conduct
Checklist
FORM-71 DM Study
Conduct Checklist

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PMSOP-1 Project Management
TEMP-87
Project RACI
Example

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Study Conduct First Patient In (FPI)

Activities Data Cleaning

Rave

Data Central
Configuration

SAE
Coding
Reconciliation
Central Manual/Exception
Labs Listings Programming

Lab Admin Lab Custom Metrics

Maintenance Reconciliation Programming

Primary
Clean Patient Information Grid
Tracker (CPT) (PIG)
Programming Programming
*Run out of Exporter
*Run out of Exporter
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High-Level Study Conduct Workflow
Process repeated until ready for DB Lock •Ensure all queries closed
•Ensure PI signature applied
EDC or External •Perform data review •Ensure answered •Ensure all DM issues
Data Data •Perform medical queries closed resolved
Acquisition coding •Ensure ongoing DM
•Resolve system Review and Freezing
queries of patient data
Database Lock
Web Services or sFTP
Queries posted
elluminate®
Back to EDC
Staging Study Data
One-time events: Analytics
•Program manual
exception listings Manual listing External data
Manual listings
•Program external Data review
data review reconciliation
Clinical data reconciliation
Data listings Data
CPT &
elluminate® Data •Program CPT and Data Management
PIG (DM
Central PIG (DM metrics)
Review Issue
Metrics)
Tracking

Patient SAE
Profiles Reconciliation

elluminate® Mapping/
Analytics Transformation •Data trending and holistic analysis
•Metrics provided to ClinOps
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Standard eClinical Study Metric Reports

▪ Temp-38 Clean Patient Tracker (CPT)

Two reports unique to eClinical ▪ Temp-40 Primary Information Grid (PIG)
are created for ALL eCS
studies as part of the eClinical
Standard package to our
clients.

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Clean Patient Tracker (CPT)
▪ The CPT collects and tracks data cleaning by subject (as opposed to assessments or forms).
▪ The CPT always includes standard RAVE metrics but may also include client requested study specific
metrics.
▪ Your EDC Developer will ensure the Subject Status CF (Custom Function) is programmed in
RAVE, and the SUBJSTAT variable is pulled into the SUBJECT eCRF.

• Collects Rave and eCRF

data and outputs into Excel.
• May include both
automated and manual
metrics.
• Available as a visualization
(a graphical representation
of data created in
elluminate).

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Clean Patient Tracker (CPT)
TEMP-38 Clean Patient Tracker Specifications

Instructions Tab

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Clean Patient Tracker (CPT )
TEMP-38 Clean Patient Tracker Specifications

CPT
Specifications
Tab

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How to Run Clean Patient Tracker from elluminate
AFTER your CPT is programmed by the tech developers and you have QC'd it
against test data and approved it, you are ready to run the Clean
Patient Tracker by following these steps:

1. Follow step by step instructions in the Instructions tab of

the template.​
2. Run 3 RAVE reports in RAVE MODULES:
• 360 Data Cleaning Progress Report
• Stream Page Status Report
• Steam-Query Detail Report
3. ​Import these reports into elluminate via the IMPORTER
tab and the Manual File Import for each report and Integrate.

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Primary
Information Grid
(PIG) Output is by a
Single Date
• Assists to drive and track
data cleaning by study.
• Specification to include
standard RAVE metrics and
may include client
requested study specific
metrics.
• Automated
• Available as a visualization
(a graph or chart created in
elluminate).

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Creating the Primary Information Grid (PIG)
TEMP-40 Primary Information Grid

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Creating the Primary Information Grid (PIG)
A cumulative report is created by copying and pasting into a
manually maintained Excel each time the CPT is delivered.

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STUDY
CONDUCT
LOCAL LAB
LISTING DESIGN,
DEVELOP & QC
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Local Lab Listing Specifications
TEMP-41 Local Lab Listing Specification
1) Clinical Data Manager will obtain the Local Lab Listing Specifications
Template.
2) Clinical Data Manager will complete the Local Lab Listing
Specification Template per the template instructions.

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Local Lab Listing Specifications
3) Clinical Data Manager will save the Local Lab Listing Specification
according to versioning requirements per PMSOP-1 Project
Management.
4) Clinical Data Manager will notify the Technical Developer that the
specification is ready for review and programming.
5) Technical Developer will retrieve the Local Lab Listing Specification
from the appropriate filing location.
6) Technical Developer will program the Local Lab Listing per the
specification and per Reports- Design/Develop/QC process.
7) Technical Developer will insert the ‘Output’ into the applicable ‘Output’
tab in the Local Lab Listing.
8) Clinical Data Manager will QC the Local Lab Listing output with the
Local Lab Listing Specification and the source data per the instructions
in the template.
9) Clinical Data Manager will indicate pass or fail and note any findings
within the ‘QC’ tab of the Local Lab Listing Specification.

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Local Lab Listing Specifications
10) Clinical Data Manager will refer to the QC findings and update the
specification, as needed based on the QC findings.
11) Clinical Data Manager will save the Local Lab Listing Specification
according to versioning requirements per PMSOP-1 Project
Management.
12) Technical Developer will review QC findings and update the
programming, as needed.
13) Technical Developer will note any comments within the ‘QC’ tab of
the Local Lab Listing Specification.
14) Steps 2-13 will continue until all issues are resolved and the final
status is ‘Pass’.
15) Data Manager will ensure the complete document is filed in
the appropriate
16) Technical Developer will deploy the Local Lab Listing program into
elluminate® production environment.

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Local Lab Listings
How to run the report from elluminate
▪ Log into elluminate and choose your study tile
▪ Click on Exporter and find your lab listing Data store
▪ Choose sheet per domain and Export
▪ The full report with all your tabs will output below and can be downloaded

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STUDY
CONDUCT
EXTERNAL DATA
DESIGN,
DEVELOP & QC
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External Data Design, Develop & QC

Template Review

• FORM-67 - Data Transfer Agreement Template

• TEMP-67 Data Integration Specification Template

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External Data Design/Develop/QC
Planning
1) Clinical Data Manager will work with the external vendor to develop the Data Transfer Agreement utilizing
Data Transfer Agreement Template (DTA). If the external vendor has a template and it meets the
minimum requirements as noted in the eClinical Solutions template, the vendor template will be
used. Otherwise, the eClinical Solutions’ template will be used.

2) Once it is determined which DTA will be used, it is recommended that the CDM and the primary vendor
contact work together to complete the required information. Additionally, the CDM should work to
complete as much information as possible and work with the vendor to define the file structure.

3) Clinical Data Manager will consult with the Biostatistician and Technical Developer for review and
feedback.

4) Clinical Data Manager will consult with the client on reviewers and approvers.

5) Clinical Data Manager will distribute the Data Transfer Agreement to those that have requested to review,
requesting feedback.

6) Once the first draft has been reviewed and comments incorporated, the CDM should work with the vendor
to receive a test data transfer via the method defined in the DTA.

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External Data Design/Develop/QC
Retrieval and Review of Test Data Transfer
1) Once the test data transfer is received, the Clinical Data Manager, or designee, is responsible to review the test
data transfer for accuracy against the file structure and other applicable details that are noted in the DTA. If any
changes need to be made in the DTA, they should be incorporated and addressed accordingly. If changes need to
be made in the file structure, then the vendor should be notified, and an updated test transfer should be received.

2) This process continues until all involved agree with the data transfer and the DTA.

3) Once there is agreement on the test data transfer and it aligns with the DTA, the DTA is approved by designated
personnel and filed by the Data Manager in the appropriate filing location.

4) The production data transfers can commence once study data is available.

5) Project Manager, Clinical Data Manager or designee will coordinate with Technical Development to ensure that
external data uploads to the sFTP are scheduled for retrieval and auto-refresh.

6) This data will be then imported into elluminate for review by the Clinical Data Manager and team, as needed.

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External Data Design/Develop/QC
Production External Data Transfers
1) External vendor will load the production external data file to the defined location as listed in the DTA for review.

2) Clinical Data Manager will perform the following review of the external data file to identify data
discrepancies. This review will be documented according to the study requirements (i.e., Data Management
Plan, Integrated Data Review and Oversight Plan (IDROP). Data Discrepancies may include:

• Duplicate records
• Missing information
• Conflicting information when compared with the clinical trial data variables for comparisons (i.e.,
subject number, initials, date of birth, sex, visit code, visit date and sample identifier)

3) If corrections are needed to the production external data file, the Clinical Data Manager will request these
corrections from the vendor via TEMP-56 External Vendor Change Request.

4) The process above will be repeated until there are no errors or issues with the data or data is deemed as
correct as noted in the TEMP-75 Data Management Report (DMR).

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External Data Design/Develop/QC
Post-Production Modifications
1) Any modifications to the Data Transfer Agreement after they have been approved will require
that the applicable steps outlined in this document are repeated and new approval from the
vendor and client is received.

2) The Data Manager will file all documentation associated with the project as defined in PMSOP-1
Project Management.

Post Approval
3) Any modifications to the External Data Integration specifications after they have been approved
will require that the applicable procedures outlined in this document are repeated.

4) The Clinical Data Manager will file all documentation associated with the project as defined in
PMSOP-1 Project Management.

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STUDY
CONDUCT
EXTERNAL DATA
RECONCILIATION

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External Data Reconciliation
External Data Preparation
1) Clinical Data Manager will work with the Vendor representative to identify the
specifications as defined in DSWI-4 External Data Design Develop QC Work
Instruction.
2) Project Manager work with the Vendor to complete FORM-58 FTP Account
Administration Form, to grant access to the sFTP folder.
3) Clinical Data Manager receive the data files from the Vendor. (Files are uploaded to
the secure FTP folder.)

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External Data Reconciliation

External Data Specifications & Programming

1) Clinical Data Manager will create the TEMP-78 External Vendor Reconciliation
Specifications and send to the Technical Developer.
2) Technical Developer will program the external data reconciliation output in Data Central.
3) Clinical Data Manager will QC the external data reconciliation output and provide feedback to
the Technical Developer via the TEMP-78 spec on the Cover_Vers_History Tab.
4) Technical Developer will implement QC updates and send to the Clinical Data Manager for final
review and approval.
5) Technical Developer will push the external data reconciliation output to Production, once
approval is achieved.
6) Clinical Data Manager will ensure the document is filed in the appropriate document repository.

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Temp-78 External Vendor Reconciliation
Specification
▪ CDM to complete the Version History in the first tab
▪ CDM will ensure the QC and Programming information is captured in this tab

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External Vendor Reconciliation Specification
▪ CDM to create specification for the programmer according to the Instructions tab
▪ CDM will provide study specific checks and OIDS in the Ext_Recon_Specs tab

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External Data Reconciliation
1) Clinical Data Manager will log into elluminate, Data Central, and
select Reconciliation under the ’Data’ menu, as well
as the corresponding External Data Store where the vendor files
for reconciliation reside.
2) Clinical Data Manager will Review the external data records to
identify data discrepancies. This review will be documented
according to the study requirements (i.e., DVS, Data Management
Plan, IDROP). Data discrepancies may include:
▪ Duplicate records
▪ Missing information
▪ Conflicting information when compared with the clinical trial
data variables for comparisons (i.e., subject number,
initials, date of birth, sex, visit code, visit date and sample
identifier)

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External Data Reconciliation
3) Clinical Data Manager will create a Query in the EDC system for
discrepancies associated with the EDC data.
4) Clinical Data Manager will create an issue for discrepancies
associated with the external data file and submit to the Vendor for
resolution via TEMP-56 External Vendor Change Request form.
5) Clinical Data Manager will follow all Queries and Issues to resolution
and then Mark as Reviewed in Data Central
6) Clinical Data Manager will repeat processes in Section 3 until all
issues are reconciled or resolved.
7) Clinical Data Manager will file all documentation associated with the
project as defined in PMSOP-1 Project Management.

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High-Level Study Conduct Workflow
Process repeated until ready for DB Lock •Ensure all queries closed
•Ensure PI signature applied
EDC or External •Perform data review •Ensure answered •Ensure all DM issues
Data Data •Perform medical queries closed resolved
Acquisition coding •Ensure ongoing DM
•Resolve system Review and Freezing
queries of patient data
Database Lock
Web Services or sFTP
Queries posted
elluminate®
Back to EDC
Staging Study Data
One-time events: Analytics
•Program manual
exception listings Manual listing External data
Manual listings
•Program external Data review
data review reconciliation
Clinical data reconciliation
Data listings Data
CPT &
elluminate® Data •Program CPT and Data Management
PIG (DM
Central PIG (DM metrics)
Review Issue
Metrics)
Tracking

Patient SAE
Profiles Reconciliation

elluminate® Mapping/
Analytics Transformation •Data trending and holistic analysis
•Metrics provided to ClinOps
35
Thank you
Please contact your Manager with any
Questions about this Training Guide.