CRF is a trial document for collecting and recording, patient- related information in a standardized and uniform manner. This is important for /the clinical trial team because the analysis and reporting of trial outcome is largely based on the completeness and accuracy of data recorded from each patient recruited in the trial. The CRF can be paper-based or in the electronic format allowing direct data entry into the database. CRF must be distinguished from protocol which provides detailed methodology of all aspects of trials whereas, CRF enables to collect subject’s inforniation enrolled in the study as per the protocol.

This topic describes: good CRF characteristics, CRF Design and Development, Purpose of information to be collected, Formatting CRF, Entering data into database, Instructions for CRF completion, Framing the questions for CRF, Formatting a questionnaire, Printing requirements, Packaging and organizing the CRF book, Errors in CRF entry, Procedure for making correction in the CRF, Electronic case record form(eCRF), Types of eCRF, Designing of eCRF, Differences between eCRF versus paper CRF.

Designing CRF

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