The requirements state that there should be Standard Operating Procedures for data collection, preparation of reports, indexing systems, handling of data including the use of computerised systems.

A final report should be prepared for each study.

As has been previously stated, the principles are clear that the Study Director is responsible for the final report.

The final report should be signed and dated by the Study Director. Remember this signature and date signify the study completion date.

It is also necessary that reports of scientists involved in the study should be signed and dated by them. Such formal reports may be appended within the final report, or retained with the study records.