Ej CRF Case Report Form

CASE REPORT FORM TEMPLATE
ESTE ES UN CRF FICTICIO SOLO A LOS

EFECTOS DE UN EJERCICIO PRACTICO
DE MONITOREO
PROTOCOL:
TITLE: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-
CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE
SAFETY, TOLERABILITY,
AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO
ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO
TOPICAL THERAPY
PROTOCOL CIM003JG 6.0
Participant Study Number: 4 1 0 0 1
Protocol Number: Ejemplo

General Instructions for Completion of the Case Report Forms (CRF)

Completion of CRFs
 A CRF must be completed for each study participant who is successfully enrolled-RANDOMIZED
 For reasons of confidentiality, the name and initials of the study participant should not appear on the CRF.
General
 EL NUMERO DE PARTICIPANTE SERA ASIGNADO POR EL SISTEMA INTERACTIVO DE
RANDOMIZACION (IVRS/IWRS) QUE TAMBIEN REGISTRA LAS VISITAS DE LOS PACIENTES. EL
CODIGO DE 5 DIGITOS = PRIMEROS DOS DIGITOS ES EL NUMERO DEL CENTRO Y LOS ULTIMOS 3
DIGITOS EL NUMERO DE PACIENTE
 Please print all entries in BLOCK CAPITAL LETTERS using a black ballpoint pen.
 All text and explanatory comments should be brief.
 Answer every question explicitly; do not use ditto marks.
 Do not leave any question unanswered. If the answer to a question is unknown, write “NK” (Not Known). If a
requested test has not been done, write “ND” (Not Done). If a question is not applicable, write “NA” (Not
Applicable).
 Where a choice is requested, cross (X) the appropriate response.
Dates and Times
 All date entries must appear in the format DD-MMM-YYYY e.g. 05-May-2009. The month abbreviations are as
follows:
January = Jan May = May September = Sep
February = Feb June = Jun October = Oct
March = Mar July = Jul November = Nov
April = Apr August = Aug December = Dec
In the absence of a precise date for an event or therapy that precedes the participant’s inclusion into the study,
a partial date may be recorded by recording “NK” in the fields that are unknown e.g. where the day and month
are not clear, the following may be entered into the CRF: N K N K 2 0 0 9
DD MMM YYYY
 All time entries must appear in 24-hour format e.g. 13:00. Entries representing midnight should be recorded
as 00:00 with the date of the new day that is starting at that time.
Correction of Errors
 Do not overwrite erroneous entries, or use correction fluid or erasers.
 Draw a straight line through the entire erroneous entry without obliterating it.
 Clearly enter the correct value next to the original (erroneous) entry.
 Date and initial the correction.
Protocol Number: Ejemplo Page 1

SCREENING VISIT 1 (DAY -28 TO -8)
Participant Number: 4 1 0 0 1
PARTICIPANT INFORMATION
Participant Number (provided by

4 1 0 0 1
IVRS)
Participant Signed Informed Consent
*Patient must sign ICF before any study Yes 1. No* 2.
procedure
0 9 J A N 2 0 1 8
Date of Informed Consent
0 1 J A N 2 0 0 1
Date of Birth
1 Male
Gender
2 Female
0 9 J A N 2 0 1 8
Date of Screening Visit

Inclusion Criteria
1) ≥18 and ≤65 years of age at the time of consent. 1. Yes 2. No
2) Patients must be able to give written informed consent and
comply with the requirements of the study protocol. 1. Yes 2. No
3) Patients must satisfy the diagnostic criteria for AD as

determined by the criteria of Hanifin and Rajka 1. Yes 2. No
4) Patients must meet either a or b and c, d at the screening visit

(Day -28 to Day -8):
a. Patients must have a history of inadequate response
(defined as sIGA score ≥3) to a stable regimen ≥4
consecutive weeks of topical corticosteroids (TCS) or
topical calcineurin inhibitors (TCI).
Note: TCS must be “potent” or “very potent”
1. Yes 2. No
according to the classification provided in, Appendix
4).
b. Patients must have a history of intolerance to, or

inability to receive standard topical therapy (e.g.
contraindication). Intolerance is defined as
discontinuation due to allergy to TCS and/or TCI.
c. EASI ≥10.
1. Yes 2. No
d. Pruritus VAS ≥50 mm

1. Yes 2. No
5) Both male and female patients of childbearing potential

must agree for the duration of the study and for a period of 120
days after administration of the last dose of study drug to the
consistent and correct use of an acceptable method of birth
control (i.e. methods of birth control which result in a low failure
1. Yes 2. No
rate [<1% per year] when used consistently and correctly such
as implants, injectables, combined oral contraceptives, some
intrauterine devices, true abstinence [when this is in line with
the preferred and usual lifestyle of the patient] or surgically
sterilized partner).
Or female patients with surgical or natural menopause with at
least 2 years from last menstrual cycle. 1. Yes 2. No

Exclusion Criteria
1-Any diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding, including aspartate aminotransferase or alanine
aminotransferase >2 x upper limit of normal (ULN), or serum creatinine ≥2 mg/dL
1. Yes 2. No
(177 µmol/L), or total white blood cells (WBC) <3000 cells/µL, or any other
medical condition that, in the opinion of the Investigator, would contraindicate the
use of an investigational drug.
2-Serological evidence of hepatitis B virus (hepatitis B surface antigen positive or
hepatitis B core antibody positive) or hepatitis C virus (HCV) (anti-HCV antibody
positive) infection (active or past infection) or human immunodeficiency virus 1. Yes 2. No
(HIV) infection. Testing prior to the study is mandatory.
3-History of skin malignancy. Patients with a history of any other malignancy, who
have been in remission for ≥5 years prior to randomization, or patients with a
history of curatively treated in situ carcinoma of the cervix at any time prior to 1. Yes 2. No
randomization, are eligible.
4-Treatment with systemic steroids, immunosuppressant agents or ultraviolet

radiation therapy within 4 weeks prior to randomization. 1. Yes 2. No
5-Treatment with potent or very potent TCS within 2 weeks prior to

randomization. 1. Yes 2. No
6-Treatment with mild or moderately potent TCS within 1 week prior to

7-Patients diagnosed with bronchial asthma, according to a recognized guideline

(e.g. GINA 201417), based on lung function tests (spirometry or PEF and/or FEV1
[forced expiratory volume in the first second] measurement) and have 1. Yes 2. No
experienced clinical symptoms consistent with bronchial asthma (e.g. wheezing,
shortness of breath); within 1 year prior to baseline.
8-Treated with an antihistamine (topical or systemic) within 1 week prior to

9-History of infection including skin infection requiring treatment with oral or

intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to 1. Yes 2. No
randomization.
10-Treatment with any investigational agent including placebo within

16 weeks prior to randomization. 1. Yes 2. No

SIGNIFICANT MEDICAL HISTORY

- Make multiple copies of this page if required
Does the participant have a history of any background/concomitant conditions/symptoms according to the following
schedule? 1 Yes 2 No
If Yes, detail in the table below and reference the ICD10 system code
http://apps.who.int/classifications/apps/icd/icd10online/
Code Title Code Title
1 Certain infectious and parasitic diseases 12 Diseases of the skin and subcutaneous tissue
Diseases of the musculoskeletal system and
2 Neoplasms 13
connective tissue
Diseases of the blood and blood-forming organs and
3 14 Diseases of the genitourinary system
certain disorders involving the immune mechanism
4 Endocrine, nutritional and metabolic diseases 15 Pregnancy, childbirth and the puerperium
5 Mental and behavioural disorders 16 Certain conditions originating in the perinatal period
Congenital malformations, deformations and
6 Diseases of the nervous system 17
chromosomal abnormalities
Symptoms, signs and abnormal clinical and
7 Diseases of the eye and adnexa 18
laboratory findings, not elsewhere classified
Injury, poisoning and certain other consequences of
8 Diseases of the ear and mastoid process 19
external causes
9 Diseases of the circulatory system 20 External causes of morbidity and mortality
Factors influencing health status and contact with
10 Diseases of the respiratory system 21
health services
11 Diseases of the digestive system 22 Codes for special purposes
SIGNIFICANT MEDICAL HISTORY

Code Condition/Symptom Onset Date Stop Date
N K U N K 2 0 1 3 D D M M M Y Y Y Y
12 Atopic Dermatitis
OR 1 Unknown OR 1 Ongoing
7 Conjuntivitis
10 Rinitis
D D M M M Y Y Y Y D D M M M Y Y Y Y
D D M M M Y Y Y Y D D M M M Y Y Y Y

SCREENING PHYSICAL EXAMINATION – PART 1

1 6 2 . cm
Weight 5 0 . kg Height
3 7 . C Method of Recording 6 0 bpm

Temperature Axillary Tympanic Rectal Oral Heart rate
1 2 3 4
1 2 bpm / mmHg
Respiratory rate Blood pressure
cm
Hepatomegaly 1. Yes 2. No If yes, size:
cm
Splenomegaly 1. Yes 2. No If yes, size:
Normal Abnormal Specify if abnormal
Central Nervous System 1. 2.

________________________________________
Cardiovascular System 1. 2.
________________________________________
Respiratory System 1. 2.
________________________________________
Gastrointestinal System 1. 2.
________________________________________
Skin 1. 2.
See sIGA and EASI score
Joints 1. 2.
________________________________________
Other 1. 2.
________________________________________

SCREENING AD EXAMINATION
Pruritus Visual Analogue Scale

Please rate how bad your itching has been in the last 24 hours on the following scale by
placing a single vertical mark (‫ )׀‬on the line.
NO WORST
ITCH IMAGINABLE
ITCH
0 10
Static Investigator’s Global Assessment (sIGA) SCORE

0-Clear
Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting 0.
1-Almost Clear
Trace, faint pink erythema with almost no induration/papulation, no oozing/crusting 1.
2-Mild Disease
Faint pink erythema with mild induration/papulation, no ozing/crusting 2.
3-Moderate Disease
Pink-red erythema with moderate induration/papulation, and there may be some
3.
oozing/crusting
4-Severe Disease
Deep/bright red erythema with severe induration/papulation, with oozing/crusting 4.
5-Very Severe Disease

Very Deep/bright red erythema with very severe induration/papulation, severe
5.
oozing/crusting

Participant Number 4 1 0 0 1
Eczema Area and Severity Index (EASI)
The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the
extent affected:
1-Assess in Each Body Region the Average Severity: Of Erythema; Edma/papulation; Excoriation and
Lichenification, according to the following grading system
2- Assess in Each Body Region the % Involvement with the following Score:
3-Complete the Table below to obtain EASI Score:
Eritema Edema Excoriación Liquenificación Area Factor SCORE

Papula
Cabeza- 1+ 1+ 1+ 1+ x1 x 0.1 0.5
Cuello
Tronco 1+ 1+ 1+ 1+ x1 x 0.3 1.5
Miembro 3+ 3+ 3+ 3+ x3 x 0.2 7.2
Superior
Miembro 2+ 2+ 2+ 2+ x2 x 0.4 6.4
Inferior
El Score Total EASI es igual a suma de las 4 regiones del cuerpo: 15.6

Laboratory Procedure
Date of Screening Laboratory 0 9 J A N 2 0 1 8
Laboratory Requisition 6 Digit Number 1 /4 / 1 /0 /0 / 1/
Sample for Pregnancy Test 1. Yes 2. No
Sample for Hematology 1. Yes 2. No
Sample for Chemistry 1. Yes 2. No
Sample for Urinalysis 1. Yes 2. No
Sample for Hepatitis B and C 1. Yes 2. No
Sample for HIV 1. Yes 2. No

Chest X Ray
Date of Chest X Ray 1 2 J A N 2 0 1 8
Result Normal or Not Clinically Significant 1. Yes 2. No
ECG
Date of ECG 1 2 J A N 2 0 1 8
Result Normal or Not Clinically Significant 1. Yes 2. No

Respiratory Assessment (in the last 4 weeks or since the last visit)
Shortness of breath. 1. Yes 2. No
Attack or recurrence of wheezing (described to the

patient as a continuous, coarse, whistling sound while 1. Yes 2. No
breathing).
Troublesome cough at night. 1. Yes 2. No
Wheeze or cough after exercise 1. Yes 2. No
Time of Assessment (24 hours):
Peak Expiratory Flow (PEF) measurements should _1__/_0__:__0_/_0___

consist of 3 good efforts with the best result
documented. It is preferable that PEF measurement be
performed before noon or the same time during each Best of 3 PEFs:
study visit whenever possible
__4__/__0___/__0___L/Min

RUN IN VISIT 2 (DAY -7 TO -1)
Participant Number
Visit Procedures
Date of RUN IN Visit 3 0 J A N 2 0 1 8
VAS AD EXAMINATION

NO WORST
ITCH IMAGINABLE
ITCH
0 10
Vital Signs
Heart Rate __0__/__6__/_0___
Systolic /Diastolic Blood Pressure SBP: __1__/_0___/__0__; DBP: __0__/__6__/__0__
Temperature ____/____, ____ °C

RUN IN VISIT 2 (DAY -7 TO -1)
Participant Number
Respiratory Assessment (since the last visit)


breathing).
Peak Expiratory Flow (PEF) measurements should _1__/__0_:_0__/_0_

__4__/__0___/__0___L/Min

BASELINE VISIT 3 (DAY 0)
Participant Number
Visit Procedures
Date of Baseline Visit 0 5 F E B 2 0 1 8

NO WORST
ITCH IMAGINABLE
ITCH
0 10

0-Clear
1-Almost Clear
2-Mild Disease
3-Moderate Disease
3.
oozing/crusting
4-Severe Disease

5.
oozing/crusting

Participant Number
extent affected:

Papula
Cabeza- 1+ 1+ 1+ 1+ x1 x 0.1 0.5
Cuello
Tronco 1+ 1+ 1+ 1+ x1 x 0.3 1.5
Miembro 3+ 3+ 3+ 3+ x3 x 0.2 7.2
Superior
Miembro 2+ 2+ 2+ 2+ x2 x 0.4 6.4
Inferior

Participant Number
Vital Signs
Heart Rate __0__/__6__/_0___
Systolic /Diastolic Blood Pressure SBP: __1__/_0___/__0__; DBP: __0__/__6__/__0__
Temperature ____/____, ____ °C
Date of Laboratory 0 6 F E B 2 0 1 8
Laboratory Requisition 6 Digit Number 1 /4 / 1 /0 /0 / 2/
Sample for Anti-CIM331 Antibody 1. Yes 2. No

Participant Number:


breathing).
Peak Expiratory Flow (PEF) measurements should _1__/_0__:_0_/_0___

__4__/__0___/__0___L/Min

Participant Number
Work Productivity and Activity Impairment Questionnaire – Atopic

Dermatitis v2.0 (WPAI-AD)
The following questions ask about the effect of your atopic dermatitis on your ability to work
and perform regular activities. Please fill in the blanks or circle a number, as indicated.
1) Are you currently employed (working for pay)?

___YES, _X__NO
If NO, check “NO” and skip to question 6
The next questions are about the past seven days, not including today.
2) During the past seven days, how many hours did you miss from work because of
problems associated with your atopic dermatitis? Include hours you missed on sick
days, times you went in late, left early, etc. because of atopic dermatitis. Do not include
time you missed to participate in this study.
______HOURS
3) During the past seven days, how many hours did you miss from work because of any other
reason, such as vacation, holidays, time off to participate in this study?
______HOURS
4) During the past seven days, how many hours did you actually work?
______HOURS (If “0”, skip to question 6)
5) During the past seven days, how much did atopic dermatitis affect your productivity
while you were working?
Think about days you were limited in the amount or kind of work you could do, days you
accomplished less than you would like, or days you could not do your work as carefully as
usual. If atopic dermatitis affected your work only a little, choose a low number. Choose a
high number if atopic dermatitis affected your work a great deal.
Consider only how much atopic dermatitis affected
productivity while you were working.
Atopic dermatitis Atopic

had no dermatitis
completely
effect on my work 0 1 2 3 4 5 6 7 8 9 10 prevented me

From
working

Participant Number
6) During the past seven days, how much did atopic dermatitis affect your ability to
do your regular daily activities, other than work at a job?
By regular activities, we mean the usual activities you do, such as work around
the house, shopping, child care, exercising, studying, etc. Think about times you
were limited in the amount or kind of activities you could do and times you
accomplished less than you would like. If atopic dermatitis affected your
activities only a little, choose a low number. Choose a high number if atopic
dermatitis affected your activities a great deal.
Consider only how much atopic dermatitis affected your ability

to do your regular daily activities, other than work at a job.
Atopic dermatitis Atopic dermatitis

had no completely
effect on my 0 1 2 3 4 5 6 7 8 9 10 prevented me
daily activities from doing my
daily activities
CIRCLE A NUMBER

Participant Number
Randomization and Study Drug Application
Date of Randomization 0 6 F E B 2 0 1 8
Medication Randomization 4 Digit Number __9__/__0__/__2__/_0___/
1. Yes* 2. No
Was Medication Applied at the Site *Complete

medication CRF

VISIT 4 (WEEK 6)
Participant Number
Visit Procedures
Date of Visit 4 Week 6 2 0 M A R 2 0 1 8

NO WORST
ITCH IMAGINABLE
ITCH
0 10

0-Clear
1-Almost Clear
2-Mild Disease
3-Moderate Disease
3.
oozing/crusting
4-Severe Disease

5.
oozing/crusting

VISIT 4 (WEEK 6)
extent affected:

Papula
Cabeza- 0+ 0+ 0+ 0+ x0 x 0.1 0
Cuello
Tronco 1+ 1+ 0+ 0+ x1 x 0.3 0.6
Miembro 2+ 2+ 1+ 1+ x2 x 0.2 2.4
Superior
Miembro 1+ 1+ 0+ 0+ x1 x 0.4 0.8
Inferior

VISIT 4 (WEEK 6)
Vital Signs
Heart Rate __0__/_7___/_2___
Systolic /Diastolic Blood Pressure SBP: __0__/__9__/__8__; DBP: __0__/__5__/_8___
Temperature __3__/__8__, __4__ °C
Date of Visit 4 Laboratory 2 0 M A R 2 0 1 8
Laboratory Requisition 6 Digit Number __1__/__4__/__1__/__0__/___0_/__3__/

VISIT 4 (WEEK 6)


breathing).
Peak Expiratory Flow (PEF) measurements should __1_/_0__:__2_/_0___

__2__/__4___/__0___L/Min

VISIT 4 (WEEK 6)
Study Drug Application
Medication Randomization 4 Digit Number __6__/__0__/__2__/_0___/
1. Yes* 2. No
Was Medication Applied at the Site *Complete

medication CRF

VISIT 5 (WEEK 12)
Visit Procedures
Date of Visit 0 8 M A Y 2 0 1 8

NO WORST
ITCH IMAGINABLE
ITCH
0 10

0-Clear
1-Almost Clear
2-Mild Disease
3-Moderate Disease
3.
oozing/crusting
4-Severe Disease

5.
oozing/crusting

VISIT 5 (WEEK 12)
extent affected:

Papula
Cabeza- 0+ 0+ 0+ 0+ x0 x 0.1 0
Cuello
Tronco 0+ 0+ 0+ 0+ x0 x 0.3 0
Miembro 1+ 1+ 0+ 0+ x1 x 0.2 0.4
Superior
Miembro 1+ 1+ 0+ 0+ x1 x 0.4 0.8
Inferior

VISIT 5 (WEEK 12)
Vital Signs
Heart Rate __0__/_7___/__8__
Systolic /Diastolic Blood Pressure SBP: __1__/__0__/__4_; DBP: __0__/_7___/_8__
Temperature (Axilar) __3__/__6__, __8__ °C
Date of Laboratory 0 8 M A Y 2 0 1 8
Laboratory Requisition 6 Digit Number __1__/__4__/__1__/__0__/___0_/__4__/

VISIT 5 (WEEK 12)


breathing).
Peak Expiratory Flow (PEF) measurements should _1__/_0__:_1__/__5__

__3__/__2___/__0___L/Min

VISIT 5 (WEEK 12)
Work Productivity and Activity Impairment Questionnaire – Atopic

Dermatitis v2.0 (WPAI-AD)
The following questions ask about the effect of your atopic dermatitis on your ability to work
and perform regular activities. Please fill in the blanks or circle a number, as indicated.
1) Are you currently employed (working for pay)?

___YES, _X__NO
If NO, check “NO” and skip to question 6
The next questions are about the past seven days, not including today.
5) During the past seven days, how many hours did you miss from work because of
problems associated with your atopic dermatitis? Include hours you missed on sick
days, times you went in late, left early, etc. because of atopic dermatitis. Do not include
time you missed to participate in this study.
______HOURS
6) During the past seven days, how many hours did you miss from work because of any other
reason, such as vacation, holidays, time off to participate in this study?
______HOURS
7) During the past seven days, how many hours did you actually work?
______HOURS (If “0”, skip to question 6)
6) During the past seven days, how much did atopic dermatitis affect your productivity
while you were working?
Think about days you were limited in the amount or kind of work you could do, days you
accomplished less than you would like, or days you could not do your work as carefully as
usual. If atopic dermatitis affected your work only a little, choose a low number. Choose a
high number if atopic dermatitis affected your work a great deal.
Consider only how much atopic dermatitis affected
productivity while you were working.
Atopic dermatitis Atopic

had no dermatitis
completely
effect on my work 0 1 2 3 4 5 6 7 8 9 10 prevented me

From
working

VISIT 5 (WEEK 12)
6) During the past seven days, how much did atopic dermatitis affect your ability to
do your regular daily activities, other than work at a job?
By regular activities, we mean the usual activities you do, such as work around
the house, shopping, child care, exercising, studying, etc. Think about times you
were limited in the amount or kind of activities you could do and times you
accomplished less than you would like. If atopic dermatitis affected your
activities only a little, choose a low number. Choose a high number if atopic
dermatitis affected your activities a great deal.
Consider only how much atopic dermatitis affected your ability

to do your regular daily activities, other than work at a job.
Atopic dermatitis Atopic dermatitis

had no completely
effect on my 0 1 2 3 4 5 6 7 8 9 10 prevented me
daily activities from doing my
daily activities
CIRCLE A NUMBER

STUDY DRUG ADMINISTRATION
STUDY DRUG ADMINSTRATION – make multiple copies of this page if required

Adverse Time of
Initials of Date Initials and
Study Drug Dose Treatment Drug Adverse
Date of dose Time of dose Reaction*
Who Applied Verified by Signature of
Kit Number Visit Applied?° Drug
? Medication CRA# CRA#
Reaction* ?
Yes X 0 6 F E B 2 0 1 8 0 9 : 0 0
Yes x 0 9 : 1 5
No  No 
9020 Baseline JI
Yes X 1 9 M A R 2 0 1 8 1 1 : 0 0
Yes  H H: M M
No  No x
6020 Week 6 DP
° After treatment discard needle and keep investigational product in individual plastic bag at quarantine area for CRA Monitoring
*Complete Adverse Event Form for all local or systemic reactions
#Section only to be completed by CRA
Protocol Number: Page 32

CONCOMITANT MEDICATIONS
CONCOMITANT MEDICATIONS UP TO 4 WEEKS BEFORE SCREEN– make multiple copies of this page if required
Medication
Formulation Dose Units Frequency Route Date started Date stopped Ongoing? Indication
name
Yes X
Levotiroxine Tablet 88 mcg QD Oral D D M M M Y Y Y Y D D M M M Y Y Y Y No 
Hypothiroidism
Clobetasona Yes 
0.05 2 1 N O V 2 0 1 8 0 6 F E B 2 0 1 8
(butirato al Cream %
g% TID Topical No X Atopic dermatitis
0.05%)
Yes 
Loratadine Tablet 10 mg QD Oral 1 9 M A R 2 0 1 8 1 9 M A R 2 0 1 8 No X
Rinitis
Nose Yes X
Oximetazolin 50 Mg% TID Topical 1 9 M A R 2 0 1 8 D D M M M Y Y Y Y No 
Rinitis
drops
Yes 
___________ ______ ____ ____ ______ ______ D D M M M Y Y Y Y D D M M M Y Y Y Y No 
___________
Yes 
___________
Yes 
___________
Yes 
___________
Yes 
___________
Yes 
___________
Yes 
___________
Protocol Number: Page 33

ADVERSE EVENTS
ADVERSE EVENTS – make multiple copies of this page if required

Adverse event name Rinitis
Intensity 1 Mild 2 Moderate 3 Severe
Is it a Serious Adverse Event (SAE) ? 1. Yes 2. No
1 Death (Date of death:______/______/_________)

2 Life-threatening
3 Persistent or symptomatic disability or incapacity
If SAE specify and complete separate SAE form:
4 Hospitalisation or prolongation of hospitalisation
5 Congenital anomaly or birth defect
6 Other important medical event
Onset Date 1 8 M A R 2 0 1 8
End Date D D M M M Y Y Y Y OR Ongoing at the end of study
Therapy 1 None 2 Drug

3 Other 4 Drug and other
Action Taken with 1 Dose unchanged 2 Dose reduced 3 Drug temporarily interrupted
Study Drug 4 Drug withdrawn 5 Dose increased
99 Not Known
Outcome 1 Recovered 2 Recovering

3 Recovering with sequelae 4 Continuing
5 Fatal 99 Not Known
1 Certain 2 Probable 3 Possible
Relationship to Study Unlikely Not related Unclassified
4 5 6
drug

ADVERSE EVENTS
Participant Number:

Adverse event name

2 Life-threatening
If SAE specify:
Onset Date D D M M M Y Y Y Y

99 Not Known

4 5 6
drug

ADVERSE EVENTS
Participant Number:

Adverse event name

2 Life-threatening
If SAE specify:
Onset Date D D M M M Y Y Y Y

99 Not Known

4 5 6
drug

FINAL STUDY OUTCOME
FINAL STUDY OUTCOME

Completion 0 8 M A Y 2 0 1 8
Subject has completed the study? 1
date :
D D M M M Y Y Y Y
If NOT completed specify last follow up date:
Reason not completed: 1 Significant non-compliance

2 Drug-related AE
(Tick only one box)
3 Treatment failure
4 Consent withdrawn
5 Lost to follow-up
6 Other (specify) ____________________
Remarks:
Investigator's Statement: I have reviewed the data recorded in this CRF and confirm that the data are
complete and accurate
Investigator (Full name): _______Dr Julio Investigador________________
Investigator Signed? 1
Signature Date: 0 8 M A Y 2 0 1 8

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CASE REPORT FORM TEMPLATE

ESTE ES UN CRF FICTICIO SOLO A LOS

PROTOCOL CIM003JG 6.0

Participant Study Number: 4 1 0 0 1

Protocol Number: Ejemplo

General Instructions for Completion of the Case Report Forms (CRF)

Protocol Number: Ejemplo Page 1

Participant Number (provided by

Protocol Number: Ejemplo Page 2

3) Patients must satisfy the diagnostic criteria for AD as

4) Patients must meet either a or b and c, d at the screening visit

b. Patients must have a history of intolerance to, or

d. Pruritus VAS ≥50 mm

5) Both male and female patients of childbearing potential

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4-Treatment with systemic steroids, immunosuppressant agents or ultraviolet

5-Treatment with potent or very potent TCS within 2 weeks prior to

6-Treatment with mild or moderately potent TCS within 1 week prior to

7-Patients diagnosed with bronchial asthma, according to a recognized guideline

8-Treated with an antihistamine (topical or systemic) within 1 week prior to

9-History of infection including skin infection requiring treatment with oral or

10-Treatment with any investigational agent including placebo within

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SIGNIFICANT MEDICAL HISTORY

SIGNIFICANT MEDICAL HISTORY

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SCREENING PHYSICAL EXAMINATION – PART 1

3 7 . C Method of Recording 6 0 bpm

Normal Abnormal Specify if abnormal

Central Nervous System 1. 2.

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Pruritus Visual Analogue Scale

Static Investigator’s Global Assessment (sIGA) SCORE

5-Very Severe Disease

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Eczema Area and Severity Index (EASI)

3-Complete the Table below to obtain EASI Score:

Eritema Edema Excoriación Liquenificación Area Factor SCORE

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Date of Screening Laboratory 0 9 J A N 2 0 1 8

Laboratory Requisition 6 Digit Number 1 /4 / 1 /0 /0 / 1/

Sample for Pregnancy Test 1. Yes 2. No

Sample for Hematology 1. Yes 2. No

Sample for Chemistry 1. Yes 2. No

Sample for Urinalysis 1. Yes 2. No

Sample for Hepatitis B and C 1. Yes 2. No

Sample for HIV 1. Yes 2. No

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Date of Chest X Ray 1 2 J A N 2 0 1 8

Result Normal or Not Clinically Significant 1. Yes 2. No

Result Normal or Not Clinically Significant 1. Yes 2. No

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Attack or recurrence of wheezing (described to the

Troublesome cough at night. 1. Yes 2. No

Wheeze or cough after exercise 1. Yes 2. No

Time of Assessment (24 hours):

Peak Expiratory Flow (PEF) measurements should _1__/_0__:__0_/_0___

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Date of RUN IN Visit 3 0 J A N 2 0 1 8

Peak Expiratory Flow (PEF) measurements should _1__/_0:0_/_0___

Heart Rate 0/6/_0___

Systolic /Diastolic Blood Pressure SBP: 1/_0_/0; DBP: 0/6/0__

Temperature /, °C

Peak Expiratory Flow (PEF) measurements should _1/0_:_0__/_0_

Heart Rate 0/6/_0___

Systolic /Diastolic Blood Pressure SBP: 1/_0_/0; DBP: 0/6/0__

Temperature /, °C

Medication Randomization 4 Digit Number 9/0/2/_0___/

Heart Rate 0/_7___/_2___

Systolic /Diastolic Blood Pressure SBP: 0/9/8; DBP: 0/5/_8___

Temperature 3/8, 4 °C

Laboratory Requisition 6 Digit Number 1/4/1/0/___0_/3/