Sheffield Teaching Hospitals NHS Foundation Trust

Research Department

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

·  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)

·  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.

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

·  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.

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

·  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).

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

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

·  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.

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

·  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).

·  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
Date comment refers to / Check date ties up
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

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