Download CRF Template

CRF Template – Instructions
CRF template version 14, 10.09.15
Please use this template as the basis for designing the Case Report Forms for your CTIMP. Please add
or delete sections or pages on this template as required and ensure that data required in the protocol
from all trial visits and data relating to endpoints defined in the protocol are captured in this CRF. It is
also important that you ensure that you do not collect any data which is not required in your
protocol, for instance if you are not required to collect alcohol and smoking history at screening you
should delete this page in the template.
The following pages/sections should be included in every CRF:
Front page
CRF Completion Instructions
Demographics (if you do record ethnicity the categories provided are from the 2001 Census)
Inclusion and Exclusion Criteria
Eligibility Review and sign off
Trial Medication Administration (choose the appropriate method of administration, or add your own)
Trial Assessments
Trial completion
Chief/Principal Investigator’s sign off
Changes in health log
Concomitant Medications log
Adverse events log
Protocol deviations log
As well as the compulsory sections above, this template includes a number of elective forms (for
instance for laboratory results); these are by no means exhaustive and cannot cover every possible
investigation, you should design these study specific forms yourself.
If you will be repeating investigations if they are out of range (for instance blood pressure or bloods),
please add pages for these, clearly marking them ‘repeats’.
Text given in blue should be completed or deleted if not to be used. Please change the colour of all
the text to black and white before printing.
Delete Screening number if not applicable and just use Subject No. and Patients Initials only. Likewise
delete Centre No. if not applicable.
When drafting the CRF, keep the version number in the footer as 1 and up-date the date with
every new draft. Keep draft as a watermark if preferred. The first version to be used with the first
study patient will be version 1. If any changes are made after that then up-date the version
number as well as the date.
This instruction page should be deleted once you have designed
your CRF, so that the front cover is page 1.
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 1 of 29
CASE REPORT FORM
Trial Title
Short Title/Acronym
Chief or Principal Investigator:
EudraCT Number:
Name of site:
Patient Initials
Subject No.
Screening No.
Centre No.
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 2 of 29
CRF Completion Instructions
General
Complete the CRF using a black ballpoint pen and ensure that all entries are complete and legible.
Avoid the use of abbreviations and acronyms.
The CRF should be completed as soon as possible after the scheduled visit.
Do not use subject identifiers anywhere on the CRF, such as name, hospital number etc., in order to
maintain the confidentiality of the subject. Ensure that the header information (i.e. subject’s initials and ID
number) is completed consistently throughout the CRF. Missing initials should be recorded with a dash
(i.e. D-L).
Each CRF visit should be signed and dated by the person completing the visit. CRFs should only be
completed by individuals delegated to complete CRFs on the Site Delegation log (and signed by
the PI).
Ensure that all fields are completed on each page:

If a test was Not Done record ND in the relevant box(es)

Where information is Not Known write NK in relevant box(es)

Where information is not applicable write NA in the relevant box(es)
Corrections to entries
If an error is made, draw a single line through the item, then write the correct entry on an appropriate
blank space near the original data point on the CRF and initial and date the change.
Do NOT

Obscure the original entry by scribbling it out

Try to correct nor modify the original entry

Use Tippex or correction fluid
Medications taken by the subject during the trial should be recorded on the “Concomitant Medications
Log” using the generic name whenever possible, except combination products which will be recorded
using the established trade name.
Complete all dates as day, month, year e.g. 13/11/14. Partial dates should be recorded as NK/11/14.
All times are to be recorded in 24 hour format without punctuation and always use 4-digits; i.e. 0200 or
2130. Midnight is recorded as 0000.
Weights should be recorded to the nearest 0.1 kg.
Investigation results
All investigation results (pathology, radiology, histology, ECG etc) required according to the protocol are
study data and must either be recorded in the CRF or printed out and filed in the CRF.
All investigation results must be reviewed, signed and dated by a study medic.
If these results are also part of the patient’s routine care then a copy of the results must also be in the
patient’s casenotes.
All rating scales and questionnaires completed by patients must be filed in the appropriate visit of the
CRF.
All print outs of results, scales and questionnaires filed in the CRF should be clearly dated and identified
by patients initials and study number.
Any clinically significant results that are different from baseline should be recorded as AEs unless
expected according to the protocol.
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 3 of 29
If a clinically significant result is not considered to be an AE then record the reason why next to the
result.
Withdrawn subjects
If a subject prematurely withdraws from the trial, ensure that the Trial Completion page is completed.
Protocol deviations
Any protocol deviations, violations or serious breach should be recorded on the Protocol Deviations Log
at the end of the CRF. This includes reasons for delayed or missed protocol visits or trial assessments,
unscheduled visits, equipment failure etc. Protocol deviations are to be taken into account in the study
analysis and publication.
CI/PI sign off
The Chief Investigator (for lead site)/Principal Investigator is responsible for the accuracy of the data
reported on the CRF. The CI/PI must sign and date the Chief/Principal Investigator’s Sign Off page to
certify accuracy, completeness and legibility of the data reported in the CRF.
Serious Adverse Events (SAEs)
SAE report forms should be completed electronically and either scanned and emailed to the R&D
monitor (or QA manager/R&D manager in the monitor’s absence) or faxed to 01482 461886 within 24
hours of the site being aware of the event.
Storage
CRF documents should be stored in a locked, secure area when not in use where confidentiality can be
maintained.
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 4 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT 1 (SCREENING/BASELINE) DEMOGRAPHIC DATA
Date of Visit: __ __ / __ __ / __ __
dd/mm/yy
Informed Consent Checklist
Yes
1.
Has the patient read and understood the Patient Information Sheet?
2.
Has the patient signed and dated the correct version of the consent
form? The patient must be consented prior to the first trial-related procedure
3.
Has the patient received a copy of the signed consent form?
No
Demographic Data
Date of Birth
__ __ / __ __ / __ __ __ __
Sex
Male
Female
dd/mm/yyyy
Ethnicity
White
Asian
Black
Chinese
Mixed race
Other
(please specify below)
___________________________________________
Alcohol consumption
Patient’s average number of units per week: ____________
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 5 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Patient
Initials
Site
Name
VISIT 1 (SCREENING/BASELINE) MEDICAL HISTORY &
HEALTH STATUS
Date of Assessment: __ __ / __ __ / __ __ dd/mm/yy
Health Status
Has the patient had any relevant medical history
in the last 10 years?
Condition / illness / surgical procedure
No
Yes, Complete below
Start date
Stop date
dd/mm/yy
dd/mm/yy
Or tick if
ongoing at
Screening/Ba
seline Visit?
____/_____/_____ ____/_____/_____
____/_____/_____ ____/_____/_____
____/_____/_____ ____/_____/_____
____/_____/_____ ____/_____/_____
____/_____/_____ ____/_____/_____
____/_____/_____ ____/_____/_____
____/_____/_____ ____/_____/_____
Concomitant Medications
Yes
No
Is the participant taking any Concomitant Medications?
If yes, please record in Concomitant Medications Log at end of CRF
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 6 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT 1 (SCREENING/BASELINE) PHYSICAL EXAM
Date of Assessment: __ __ / __ __ / __ __
dd/mm/yy
Was Physical Examination performed?
System
*Abnormal
Normal
No
Not
done
Yes, Complete below
*If noted ABNORMAL, please provide
brief description and comment if
clinically significant or not (CS/NCS)
General Appearance
Skin
Eyes, Ears, Nose & Throat
Head, Neck & Thyroid
Cardiovascular
Respiratory
Abdomen
Extremities
Genitalia
Anorectal
Lymph Nodes
Muscular-Skeletal
Neurological
Others (please specify)
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 7 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT 1 (SCREENING/BASELINE) VITAL SIGNS & ECG
Were Vital Signs performed?
No (comment below)
Yes, Complete below
Comment*: __________________
__ __ / __ __ / __ __
Date of Vital Signs:
dd/mm/yy
________:_______
Time of Vital Signs:
HH:MM
Blood Pressure supine/standing/seating :
Pulse:
____ ___ ___ beats/min
Weight:
___ ___ ___ . ___ kg
Oral/ Tympanic Temperature:
___ ___ ___ / ___ ___ ___ mmHg
Height:
___ . ___ ___ m
___ ___ . ___ °C
No (comment below)
Was an ECG performed?
Yes, Complete below
Comment*: __________________
__ __ / __ __ / __ __
Date & time of ECG:
dd/mm/yy
________:_______
HH:MM
Within normal limits
Abnormal, NOT clinically significant
The ECG is:
Abnormal, clinically significant, please specify:
_____________________________________________________________
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 8 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT 1 (SCREENING/BASELINE) LAB TESTS
Laboratory tests
Have blood/urine/tissue samples been taken for the tests listed below?
Yes, date samples taken: __ __ / __ __ / __ __
Time sample taken ________:_______
HH:MM
No, give reason:_______________________________________
Blood/urine/tissue test
Done?
Yes
No
Reason if not done
Have test results that are outside normal limits been printed off from Patient Centre and
checked, signed and dated by CI/PI/study medic?
Yes
No, give reason:_______________________________________
Have these results been filed in the CRF?
Yes
No, give reason:_______________________________________
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 9 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Patient
Initials
Site
Name
VISIT 1 (SCREENING/BASELINE) < INSERT ASSESSMENT>
Clinical <insert assessment> Laboratory tests
performed?
No (comment below)
Yes, Complete below
Comment *: __________________
__ __ / __ __ / __ __
Date of Sample:
dd/mm/yy
________:_______
Time of Sample
HH:MM
No
Was laboratory sample taken at different hospital
to <insert investigator’s site lab name>?
Yes, Complete below
Laboratory name / Location:
__________________________________________
<INSERT ASSESSMENT>
Value
Laboratory Parameter
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Unit (site to
pre-complete
prior to the
finalization of
the template)
If parameter indicated as out of
normal range on report, please
check if clinically significant:
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Page 10 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT 1 (SCREENING/BASELINE) SMOKING / ALCOHOL
STATUS
Date of Assessment: __ __ / __ __ / __ __
dd/mm/yy
Has the participant ever smoked?
Current Smoker
No
Yes, Complete below
Participant’s average daily use:
- Number of cigarettes : ___ ___
- Number of cigars : ____ ___
- Number of pipes : ___ ___
Smoked for ___ ___ months/years
Smoked for ___ ___ months/years
Former smoker
Date when smoking ceased: __ __ / __ __ / __ __
dd/mm/yy
When smoking, participant’s average daily use:
- Number of cigarettes : ___ ___
- Number of cigars : ____ ___
- Number of pipes : ___ ___
Participant’s alcohol consumption
Participant’s average consumption per <insert time frame stated in protocol>:
- Number of units of wine : ___ ___
- Number of units of beer : ____ ___
- Number of units of spirits : ___ ___
(see protocol for definition of units)
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 11 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT 1 (SCREENING/BASELINE) ELIGIBILITY CRITERIA
Date of Assessment: __ __ / __ __ / __ __
dd/mm/yy
Inclusion Criteria - include if ‘yes’ to all
1.
Yes
No
Yes
No
Adults ≥18 years
2.
3.
4.
Able to provide written informed consent.
5.
Able to complete study assessments
6.
Exclusion Criteria - exclude if ‘yes’ to any
1.
2.
3.
5.
6.
7.
Pregnancy
8.
Involvement in another CTIMP within the past four weeks
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 12 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Patient
Initials
Site
Name
VISIT 1 (SCREENING/BASELINE) PARTICIPANT ELIGIBILITY
SIGN-OFF
Participant’s eligibility Investigator Sign-Off
Is the participant eligible to take part in the trial?
Yes
Study doctor on the Delegation Log
Signature: __________________ Date : __ __ / __ __ / __ __
No, Please give
reason for screen
failure below
Reason(s) for screen failure:
End of Screening/Baseline visit checklist
Yes
1.
Have all Screening/Baseline Visit procedures been completed?
2.
Have there been any protocol deviations or violations?
If yes, please record on the Protocol Deviations Log at end of CRF
3.
Has the GP letter been sent?
4.
Is the patient continuing with the study?
If not, complete Trial Completion page at end of CRF.
No
Visit completed by:
Name
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Signature
Date
Page 13 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
VISIT X <INSERT VISIT NAME>
RANDOMISATION/ENROLMENT
Participant Randomisation/Enrolment
Participant study Number allocated:
____ ____ ____
__ __ / __ __ __ / __ __ __ __
Date of Randomisation/Enrolment:
dd/mm/yy
VISIT X <INSERT VISIT NAME> TRIAL MEDICATION
ADIMINSTRATION
<Insert name of trial medication> Administration
CHOOSE APPROPRIATE DOSING/DISPENSING TABLE FOR YOUR PROTOCOL
AND MODIFY AS REQUIRED
Date of Dosing
dd/mm/yy
Time of Dosing
(24 hr)
____/____/____
____ ____:____ ____
____/____/____
____ ____:____ ____
Start date of dosing
dd/mm/yy
Stop date of dosing
dd/mm/yy
____/_____/_____
____/_____/_____
____/_____/_____
____/_____/_____
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Dose
(including units)
Dose
(including units)
Comment ONLY if dose
delayed, interrupted, reduced
or altered
Comment ONLY if dose
delayed, interrupted, reduced
or altered
Page 14 of 29
< Short Title/Acronym>
Subject/Scr
eening No.
Site
Patient
Initials
Name
INFUSION
Date of Infusion
dd/mm/yy
Start time of
infusion
Stop time of infusion
____/____/____
______:______
______:______
____/____/____
______:______
______:______
Dose
(including units)
Comment ONLY
if dose delayed,
interrupted,
reduced or
altered
VISIT X <INSERT VISIT NAME> TRIAL MEDICATION
DISPENSING
DISPENSING
Date of Dispensing IMP
dd/mm/yy
Quantity Dispensed
(no. tablets/
pens/patches)
<Daily> Dose
(including units)
Comment ONLY if dose
delayed, reduced or altered
____/____/____
Note: add more rows depending on how IMP is dispensed and
Returned
RETURNS (add to subsequent visit)
Date of Returning IMP
dd/mm/yy
Quantity Returned
(no. tablets/
pens/patches)
Comment on compliance
____/____/____
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 15 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Patient
Initials
Site
Name
VISIT X <INSERT VISIT NAME> BEGINNING OF VISIT
CHECKLIST
Date of Visit: __ __ / __ __ / __ __
Beginning of Visit Checklist
1.
Patient happy to proceed in study?
2.
Have there been any changes in the patient’s health since baseline?
If yes, please record in Changes in Health Log at end of CRF
3.
Have there been any Adverse Events?
If yes, please record in Adverse Events Log
4.
Yes
No
Have there been any changes in Concomitant Medications since
baseline?
If yes, please record in Concomitant Medications Log
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 16 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
VISIT X <INSERT VISIT NAME> PHYSICAL EXAM
SIT X <INSERT VISIT NAME>
Date of Assessment: __ __ / __ __ / __ __
dd/mm/yy
Was Physical Examination performed?
System
*Abnormal
Normal
No
Not
done
Yes, Complete below
*If noted ABNORMAL, please provide
brief description and comment if
clinically significant or not (CS/NCS)
General Appearance
Skin
Eyes, Ears, Nose & Throat
Head, Neck & Thyroid
Cardiovascular
Respiratory
Abdomen
Extremities
Genitalia
Anorectal
Lymph Nodes
Muscular-Skeletal
Neurological
Others (please specify)
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 17 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
VISIT X <INSERT VISIT NAME> VITAL SIGNS & ECG
Were Vital Signs performed?
No (comment below)
Yes, Complete below
Comment*: __________________
__ __ / __ __ / __ __ __
Date of Vital Signs:
dd/mm/yy
________:_______
Time of Vital Signs:
HH:MM
Blood Pressure supine/standing/seating :
Pulse:
____ ___ ___ beats/min
Weight:
___ ___ ___ . ___ kg
Oral/ Tympanic Temperature:
___ ___ ___ / ___ ___ ___ mmHg
Height:
___ . ___ ___ m
___ ___ . ___ °C
No (comment below)
Was an ECG performed?
Yes, Complete below
Comment*: __________________
__ __ / __ __ / __ __
Date & time of ECG:
dd/mm/yy
________:_______
HH:MM
Within normal limits
Abnormal, NOT clinically significant
The ECG is:
Abnormal, clinically significant, please specify:
_____________________________________________________________
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 18 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
VISIT X <INSERT VISIT NAME> LAB TESTS
Laboratory tests
Have blood/urine/tissue samples been taken for the tests listed below?
Yes, date samples taken: __ __ / __ __ / __ __ dd/mm/yy
Time of Sample ________:_______
HH:MM
No, give reason:_______________________________________
Blood/urine/tissue test
Done?
Yes
No
Reason if not done
Have test results that are outside normal limits been printed off from Patient Centre and
checked, signed and dated by CI/PI/study medic?
Yes
No, give reason:_______________________________________
Have these results been filed in the CRF?
Yes
No, give reason:_______________________________________
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 19 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Patient
Initials
Site
Name
VISIT X <INSERT VISIT NAME> < INSERT ASSESSMENT>
Clinical <insert assessment> Laboratory tests
performed?
No (comment below)
Yes, Complete below
Comment *: __________________
__ __ / __ __ __ / __ __ __ __
Date of Sample:
dd/mm/yy
________:_______
Time of Sample
HH:MM
No
Was laboratory sample taken at different hospital
to <insert investigator’s site lab name>?
Yes, Complete below
Laboratory name / Location:
__________________________________________
<INSERT ASSESSMENT>
Value
Laboratory Parameter
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Unit (site to
pre-complete
prior to the
finalization of
the template)
If parameter indicated as out of
normal range on report, please
check if clinically significant:
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Page 20 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
VISIT X <INSERT VISIT NAME>< ASSESSMENT PERFORMED>
<Insert other assessments>
VISIT X <INSERT VISIT NAME> TRIAL MEDICATION
ADIMINSTRATION
<Insert name of trial medication> Administration
CHOOSE APPROPRIATE DOSING/DISPENSING TABLE FOR YOUR PROTOCOL
AND MODIFY AS REQUIRED
Date of Dosing
dd/mm/yy
Time of Dosing
(24 hr)
Dose
(including units)
____/_____/______
____ ____:____ ____
____/_____/______
____ ____:____ ____
Start date of dosing
dd/mm/yy
Stop date of dosing
dd/mm/yy
____/_____/_____
____/_____/_____
____/_____/_____
____/_____/_____
Dose
(including units)
Comment ONLY if dose
delayed, interrupted, reduced
or altered
Comment ONLY if dose
delayed, interrupted, reduced
or altered
INFUSION
Date of Infusion
dd/mm/yy
Start time of
infusion
Stop time of infusion
____/_____/______
______:______
______:______
____/_____/______
______:______
______:______
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Dose
(including units)
Comment ONLY
if dose delayed,
interrupted,
reduced or
altered
Page 21 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
VISIT X <INSERT VISIT NAME> TRIAL MEDICATION
DISPENSING
DISPENSING
Date of Dispensing IMP
dd/mm/yy
Quantity Dispensed
(no. tablets/
pens/patches)
<Daily> Dose
(including units)
Comment ONLY if dose
delayed, reduced or altered
____/_____/____
Note: add more rows depending on how IMP is dispensed and
Returned
RETURNS (add to subsequent visit)
Date of Returning IMP
dd/mm/yy
Quantity Returned
(no. tablets/
pens/patches)
Comment on compliance
____/_____/____
VISIT X <INSERT VISIT NAME> END OF VISIT CHECKLIST
Yes
End of Visit Checklist
No
Have there been any protocol deviations or violations?
If yes, please record on the Protocol Deviations Log
Is the patient continuing with the study?
If not, complete Trial Completion page at end of CRF.
Visit completed by:
Name
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Signature
Date
Page 22 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
TRIAL COMPLETION
Yes, Please provide date of last visit:
__ __ / __ __ / 2 0 __ __
Did participant complete the trial?
dd/mm/yy
No, Please provide date of withdrawal and complete
below:
__ __ / __ __ / 2 0 __ __
dd/mm/yy
Early Withdrawal: please tick most appropriate reason for participant not completing the trial:
Adverse Events related: please state related AE: ____________________________________ (add details to AE page)
Participant’s decision, specify: __________________________
Investigator’s decision, specify: __________________________
Sponsor’s decision
Lost to follow up
Patient deceased
Other, specify: __________________________
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 23 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Patient
Initials
Site
Name
CHANGES IN HEALTH LOG
Record any changes in health of patient from baseline
Changes in current medical conditions/diseases
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Start date
Stop date
Page 24 of 29
Ongoing
Is this change an AE?
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
CONCOMITANT MEDICATIONS LOG
Medication
Indication
Medication
start date
Medication
stop date
Ongoing
YES/NO
Record any medication the patient is taking at baseline or changes to medication from baseline
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 25 of 29
Total dose
per
frequency
marked
Unit
Route
Frequency
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
ADVERSE EVENTS LOG
Adverse Event
Dates
Times
if relevant
Severity
Outcome
Actions
taken
Report any trends in the nature and
frequency of AEs to R&D
Relationship
to study
drug
Expected
or not for
study drug
Serious
Adverse
Event
SAE requires
reporting to
R&D on SAE
form
1.
Start date
Start time
___ / ___ / ___
___ : ___
dd/mm/yy
Stop date
Stop time
___ / ___ / ___
___ : ___
dd/mm/yy
Study doctor name:
Yes
Yes
No
No
Signature:
Date:
2.
Start date
Start time
___ / ___ / ___
___ : ___
Yes
Yes
No
No
dd/mm/yy
Stop date
Stop time
___ / ___ / ___
___ : ___
dd/mm/yy
Severity
Outcome
Actions taken
1 = Mild
2 = Moderate
3 = Severe
1 = Resolved
2 = Ongoing
1 = None
2 = Therapy prescribed
3 = Study drug interrupted
4 = Discontinued study
5 = Other,
specify………………..
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Study doctor name:
Relationship to study
drug
1 = Not related
2 = Unlikely to be related
3 = Possibly related
4 = Probably related
5 = Definitely related
Signature:
If AE is possibly or probably
or definitely related to study
drug, is AE expected or not
for study drug
1 = Expected
2 = Unexpected (not described
in SPC, protocol or other
product information)
Page 26 of 29
Date:
Serious adverse event
1 = Resulted in death
2 = Life threatening
3 = Requires hospitalisation
4 = Prolongation of existing hospitalisation
5 = Congenital anomaly/birth defect
6 = Other, specify ………………………………………
Report SAE within 24hrs to R&D on SAE form unless SAE
does not need reporting according to the protocol.
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
ADVERSE EVENTS LOG
Adverse Event
Dates
Times
if relevant
Severity
Outcome
Actions
taken
Report any trends in the nature and
frequency of AEs to R&D
Relationship
to study
drug
Expected
or not for
study drug
Serious
Adverse
Event
SAE requires
reporting to
R&D on SAE
form
3.
Start date
Start time
___ / ___ / ___
___ : ___
dd/mm/yy
Stop date
Stop time
___ / ___ / ___
___ : ___
dd/mm/yy
Study doctor name:
Yes
Yes
No
No
Signature:
Date:
4.
Start date
Start time
___ / ___ / ___
___ : ___
Yes
Yes
No
No
dd/mm/yy
Stop date
Stop time
___ / ___ / ___
___ : ___
dd/mm/yy
Severity
Outcome
Actions taken
1 = Mild
2 = Moderate
3 = Severe
1 = Resolved
2 = Ongoing
1 = None
2 = Therapy prescribed
3 = Study drug interrupted
4 = Discontinued study
5 = Other,
specify………………..
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Study doctor name:
Relationship to study
drug
1 = Not related
2 = Unlikely to be related
3 = Possibly related
4 = Probably related
5 = Definitely related
Signature:
If AE is possibly or probably
or definitely related to study
drug, is AE expected or not
for study drug
1 = Expected
2 = Unexpected (not described
in SPC, protocol or other
product information)
Page 27 of 29
Date:
Serious adverse event
1 = Resulted in death
2 = Life threatening
3 = Requires hospitalisation
4 = Prolongation of existing hospitalisation
5 = Congenital anomaly/birth defect
6 = Other, specify ………………………………………
Report SAE within 24hrs to R&D on SAE form unless SAE
does not need reporting according to the protocol.
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
PROTOCOL DEVIATIONS LOG
Protocol deviations are to be taken into account in the study analysis and publication
No.
Date
Protocol Deviation
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Corrective and preventative actions (CAPA)
Page 28 of 29
< Short Title/Acronym>
Subject/Scre
ening No.
Site
Patient
Initials
Name
CHIEF/PRINICIPAL INVESTIGATOR’S SIGN OFF
Chief/Principal Investigator’s Signature Statement
I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study
information obtained for this participant. All entries were made either by me or by a person under my
supervision who has signed the Delegation Log.
Chief/Principal Investigator’s Signature
__________________________________
Chief/Principal Investigator’s Name
Date of
Signature
__ __/ __ __ / __ __
dd/mm/yy
__________________________________
ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF
WITHOUT A SIGNED DATA QUERY FORM.
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX
Page 29 of 29