Important points to remember when completing all CRF forms:
1. Ensure all staff completing CRFs have sufficient information on the trial and have
been adequately trained on how to complete each form.
2. Ensure all data entered is legible i.e. use block letters
3. Complete forms using permanent ink.
4. Complete headers for patient details on every page.
5. Any errors must be crossed out with a single line leaving the original entry legible.
The correction should be initialled and dated by the investigator. Where
appropriate, errors should be explained.
6. Any corrections made should be distinctly different from the original, and done
consistently throughout the trial (e.g. made in a different coloured ink).
7. Any omissions should be explained.
8. Complete all forms in the order they appear unless otherwise stated.
9. Unsigned forms or forms signed by an individual whose name does not appear on
the copy of the Site Signature and Delegation Log held by the WCTU will not be
accepted.
10. Every effort must be made to answer all questions.
11. Where ‘Yes’, ‘No’, ‘N/K’ options are provided at least one option must be ticked.
12. If a question cannot be answered at the time the CRF is being completed, but the
data will be available at a later date, leave the response blank and provide the data
when it becomes available.
13. If a question cannot be answered and the data will never become available tick or
write ‘Not Known’ and provide a reason for this.
14. All data entered in a CRF must be understandable, i.e. use only the units of
measure indicated.
15. All missing data items will be queried until received.
16. Remember to sign and date the bottom of the form once complete.
17. If CRF is on No Carbon Required (NCR) paper, the top (original) copy of each
form must be returned to the WCTU. Where CRFs are not carbon copied,
remember to photocopy each page and retain a copy for the site file.
16-1 CRF Completion Guidance
Version 1.0
November 2013
18. The investigator must archive the Investigator Site File (ISF) including copies of
the CRFs.
19. The source data must be readily available and retrievable for monitoring, auditing
and inspection.
20. Document everything: Errors and omissions are acceptable but not without
explanation.
16-1 CRF Completion Guidance
Version 1.0
November 2013