通用病例报告表填写指南--Generic Case Report Form Completion Guidelines

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Generic Case Report Form Completion Guidelines

General Instructions

Abbreviations

CRF
case report form

NK
not known

ND
not done

NA
not applicable

NAD
no abnormalities detected

AE
adverse event

SAE
serious adverse event

General guidance

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Always refer to the study protocol before completing forms.

·
The CRF must always be completed by authorised site personnel. If you are new to a trial, make sure you have completed the delegation form in the site file.

·
Ensure data entries are consistent with the source data (usually the patients medical record)

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Always use black ballpoint ink

·
Always write clearly ensuring that the entries are legible to others

·
Avoid abbreviations and acronyms, unless they are standard medical abbreviations or known to be acceptable.

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Ensure that you complete the ‘header’ information on each page consistently.

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Always fill in EVERY field on each CRF page (unless indicated otherwise). If a procedure was not done or not applicable, enter ND or NA where appropriate.

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Do not write outside of the designated boxes. Write comments on the comments page.

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Completely fill in each box using leading ‘0’ if needed.

·
To amend incorrect data on a CRF page,

score through the error with a single line,

do not obscure the original entry (do not use correction fluid),

write the correct data nearby,

initial and date each amendment.

·
Do not record incomplete dates (i.e. if you know the month and year, but not the day, record- NK/04/05).

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Record dates in the requested format (i.e 11/04/05; 11 APR 05; 11 APR 2005)

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Ensure you use the correct units for weight, height, lab results etc

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Ensure AE’s are consistent through visits (if required). If they are new at cycle 1, but continue through cycle 2, make sure it is documented at cycle 2 as well.

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If a medication was given for an adverse event, make sure it is documented as fully as possible.

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For tumour assessment pages, make sure tumours are documented consistently- in the same order at each assessment. If a lesion has disappeared between assessments, record them on the page as ‘not present’. Check that assessment has been carried out by the same method (CT, physical, MRI etc).

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Ensure that all CRF pages are signed and dated by the person completing the form.

Page Specific Instructions
Header information- all pages
Field	Comments	Consistency check
Trial Number	STH project number	Check correct study
Subject Initials	If 2 initials, use dash	Not blank, check consistency
Subject number	Enter patient number	Not blank, check consistency
Baseline Demographics
Field	Comments	Consistency check
Visit Date	Dd/mmm/yy	Visit on/after consent date
Sex	Circle	Not blank
Date of Birth	Dd/mmm/yy	Not blank
Age	Whole years	Not blank
Height	Metric (cm)	Correct format
Weight	Metric (kg)	Correct format
BSA	Body Surface Area (sq. m)	Check correct
Race	Text	Not blank
BMI	Metric	Check correct
Smoker	Circle/ how many per day/ type	If yes, amount completed
BP	Systolic/diastolic mm/hg	Correct format
Pulse	Beats/minute	Correct format
Temperature	Celsius	Correct format
Route	Circle	Not blank
Alcohol use	Units/week	Not blank
Inclusion criteria met	Should be yes to continue	Must be yes
Exclusion criteria met	Should be no to continue	Must be no
Date of Informed consent	Dd/mmm/yy- date patient signs consent form	Date on/ before visit date
Signature	Person completing the form	signed
Past Medical History
Field	Comments	Consistency Check
No	Number of event	Line number sequential
Condition/illness/surgical procedure	Describe fully	Fully described
Start date	Dd/mmm/yy	Must be before consent date
Ongoing	Tick if ongoing	If yes, end date should be blank
End date	Dd/mmm/yy	If ongoing blank, must have and end date
Medication taken	Y/N- if yes, enter on con meds page	If yes, check con med page for matching medication
Signature	Person completing the form	Signed
Vital Signs
Field	Comments	Consistency check
Visit date	DD/mmm/yy	Check date within protocol timeframe
Time	24 hour clock- time of assessment	Not blank
BP	Systolic/diastolic mm/hg	Correct format
Pulse	Beats/minute	Correct format
Temperature	Celsius	Correct format
Route	Circle	Not blank
Signature	Person completing the form	Signed
Physical Examination
Field	Comments	Consistency check
Visit date	Dd/mmm/yy	Check date within protocol timeframe
Visit number		Sequential visit dates completed
Exam date	Dd/mmm/yy day exam performed	Check date within protocol timeframe- can be different from visit date
Exam performed by	Qualified person- on delegation list	Check delegation list
General	Circle and comment if abnormal	If abnormal- check comment entered
Head/neck/ENT	Circle and comment if abnormal	If abnormal- check comment entered
Cardiovascular	Circle and comment if abnormal	If abnormal- check comment entered
Musculo-skeletal	Circle and comment if abnormal	If abnormal- check comment entered
CNS	Circle and comment if abnormal	If abnormal- check comment entered
Respiratory	Circle and comment if abnormal	If abnormal- check comment entered
Dermatological	Circle and comment if abnormal	If abnormal- check comment entered
Gastro-intestinal	Circle and comment if abnormal	If abnormal- check comment entered
Genito-urinary	Circle and comment if abnormal	If abnormal- check comment entered
Blank- complete if others performed	Circle and comment if abnormal	If abnormal- check comment entered
Signature	Person completing form	Signed
Haematology
Field	Comment	Consistency Check
Visit date	Dd/mmm/yy	Check date within protocol timeframe
Visit number		Sequential visit dates completed
Sample date	Dd/mmm/yy	Check date within protocol timeframe- can be different from visit date
Sample time	Time of collection	Not blank
Laboratory name	Ensure reference ranges are in site file or present in source data	Check reference ranges present
Haemoglobin	g/dl	Not blank
WBC	109/L	Not blank
Platelets	109/L	Not blank
RBC	1012/L	Not blank
HCT	l/l	Not blank
Neutrophils		Not blank
Lymphocytes		Not blank
Monocytes		Not blank
Eosinophils		Not blank
Basophils		Not blank
Blank-	Complete if others carried out	Not blank
Signature	Person completing the form	Signed
Chemistry
Field	Comment	Consistency check
Visit date	Dd/mmm/yy	Check date within protocol timeframe
Visit number		Sequential visit dates completed
Sample date	Dd/mmm/yy	Check date within protocol timeframe- can be different from visit date
Sample time	Time of collection	Not blank
Laboratory name	Ensure reference ranges are in site file or present in source data	Check reference ranges present
Sodium	Mmol/L	Not blank
Potassium	Mmol/L	Not blank
Urea	Mmol/L	Not blank
Creatinine	Mmol/L	Not blank
Bicarbonate	Mmol/L	Not blank
Chloride	Mmol/L	Not blank
Total protein	g/L	Not blank
Albumin	g/L	Not blank
Calcium	Mmol/L	Not blank
Adj Calcium	Mmol/L	Not blank
Total bilirubin	Umol/L	Not blank
Alk. Phos.	IU/L	Not blank
AST	IU/L	Not blank
ALT	IU/L	Not blank
GGT	IU/L	Not blank
Signature	Person completing form	Signed
Immunology
Field	Comments	Consistency Check
Visit date	Dd/mmm/yy	Check date within protocol timeframe
Visit number		Sequential visit dates completed
Sample date	Dd/mmm/yy	Check date within protocol timeframe- can be different from visit date
Sample time	Time of collection	Not blank
Laboratory name	Ensure reference ranges are in site file or present in source data	Check reference ranges present
Blank	Complete as appropriate	Not blank
Signature	Person completing form	Signed
Urinalysis
Field	Comments	Consistency check
Visit date	Dd/mmm/yy	Check date within protocol timeframe
Visit number		Sequential visit dates completed
Sample date	Dd/mmm/yy	Check date within protocol timeframe- can be different from visit date
Sample time	Time of collection	Not blank
Laboratory name	Ensure reference ranges are in site file or present in source data	Check reference ranges present
Glucose		Not blank
Bilirubin		Not blank
Ketones		Not blank
Spec. gravity		Not blank
Blood		Not blank
pH		Not blank
Protein		Not blank
Urobilinogen		Not blank
Nitrite		Not blank
Leucocytes		Not blank
Blank	Complete as appropriate	Not blank
Pregnancy	Circle	Not blank
Signature	Person completing form	Signed
Investigations
Field	Comments	Consistency check
Visit date	Dd/mmm/yy	Check date within protocol timeframe
Visit number		Sequential visit dates completed
Sample date	Dd/mmm/yy	Check date within protocol timeframe- can be different from visit date
Sample time	Time of collection	Not blank
ECG	Circle and comment if abnormal	If abnormal- check comment entered
Xray	Circle and comment if abnormal	If abnormal- check comment entered
CT scan	Circle and comment if abnormal	If abnormal- check comment entered
MRI scan	Circle and comment if abnormal	If abnormal- check comment entered
PET scan	Circle and comment if abnormal	If abnormal- check comment entered
Dexa scan	Circle and comment if abnormal	If abnormal- check comment entered
Doppler	Circle and comment if abnormal	If abnormal- check comment entered
Ultrasound	Circle and comment if abnormal	If abnormal- check comment entered
Blank	Complete as appropriate	If abnormal- check comment entered
Signature	Person completing from	Signed
Comments
Field	Comments	Consistency check
Date	Dd/mmm/yy	Check date ties up
	Date comment refers to
Relevant page	Comment refers to specific page	Check page ties up
Comment	Keep comment brief	Check legibility
Signature	Person completing form	Signed
Concomitant Medications
Field	Comments	Consistency check
CM No	Line number of medication	Line number sequential
Medication	Generic name	generic term used
Indication	Condition/event	correct indication
Route	Enter relevant code	Route correct
Dose/unit	Total dose/day	Dose correct
Frequency	Enter relevant code	Frequency correct
Prophylaxis	Yes or No	If Yes, no AE needed
Start date	Dd/mmm/yy	After entry onto study
Ongoing	Tick if ongoing	If yes, no end date
End date	Dd/mmm/yy	If ongoing= no, end date required
Related AE no	If taken for adverse event, document which one	If AE, check AE page for matching entry
Signature	Person completing form	signed
Adverse Events
Field	Comment	Consistency check
AE No	Line number of event	Line number sequential
Event Name	Describe condition rather than symptoms	Condition entered not symptoms
System	Enter relevant code	Not blank
Start date	Dd/mmm/yy	After entry onto study
Ongoing	Tick if ongoing	If yes, no end date
End date	Dd/mmm/yy	If ongoing = no, end date required
Intensity	Enter relevant code	Not blank
Relation to stud drug	Enter relevant code	Not blank
Study drug action	Enter relevant code	Not blank
Outcome	Enter relevant code	Not blank
Serious?	Yes/ No if yes complete SAE report form	If yes, SAE reported?
Signature	Person completing form	Signed