Study Documentation

CRFs are prepared once the protocol is agreed and before the study starts (i.e. before the first participant is enrolled). CRFs must provide the format for capturing all information that is expected to be collected in the study, as outlined in the protocol. The ICH Guidance on Statistical Principles for Clinical Trials establishes that:

• Data collected must be in full accordance with the protocol.
• CRF must be established before study starts.
• Data collected should enable the analysis to be performed.
• Identification of protocol compliance. - The CRF is also a good tool to check how well the study staff are following the protocol. If data is missing, measurement dates are not in line with the requested protocol timelines and data differ between the source documents and the CRF, this indicates that errors were made and need to be corrected.
• Participant codes must allow identification of all data reported for each participant – unambiguously.

The sponsor needs to ensure that there is a numbering system in place that gives a unique number to each patient who is screened for a study and another number for those patients that can ultimately get enrolled into the study. This number does not allow the identification of the patient. Only the investigator has a list that connects this number with the name and address of the patient. The study monitor, checks the performance of the study site, has the ability to look into the source documents.