Case Report Form (CRF) - Clinical Trials

The ICH GCP Guidelines say: The reason for having CRFs in a study is to (collect the necessary information about:

• the patients
•  the administration of the study drug
• the outcome of the assessments.

CRFs are the official documentation of the trial for the authorities, and together with the source documents will be closely examined during audits and inspections.The data on the CRFs will be entered into a computer system and the statistical analyses will then be performed. The data on the CRFs is therefore the basis for the trial report and also for any publications, as well as making up part of the data for regulatory approval of a new drug.

When completing the form use a black ball point pen to complete the CRF. If the CRFs are printed on carbonless duplication paper, always make sure that a suitable separator is inserted under the form being completed. If for some reason you cannot complete part of the form, you shouldn’t just leave a blank space ~ this is impossible for the people doing the data entry into the computer to interpret. Instead write unknown, uncertain, missing or test not donr as appropriate, or similar unambiguous words. Avoid using the ambiguous phrase, ‘not available’.The CRFs must be signed where indicated by the Principal Investigator to indicate that
he/she believes they are complete and correct. Some Sponsors require a signature on each page of the CRF, some only a signature on the final page.

Ensure legibility of all data entries. Corrections should be made as follows:

• Cross out the incorrect entry with a single line - the incorrect entry should still be readable, on no account use liquid correcting fluid.
• Enter the correct data.
• Initial and date the correction, and give an explanation of the correction if it is not obvious why it was changed.