Drug Evaluation Committee 2008-30 Version Control of Investigator Site Procedure Manual (Part 1)
Related classification: Other
Date of first publication: January 2009
Question
We would like to revise the procedure manual (SOP) of Investigator Site. The current SOP is divided into separate volumes for each item, and we are considering revising it to make it a single volume. However, the number of editions is assigned to each book, so there is a 2nd edition, a 10th edition, etc. In this case, we would like to revise the SOP into a single book. In this case, please let me know how we should do the edition number when we revise it to one volume.
JPMA's Opinion
There is no rule in GCP regarding the number of editions of procedure manuals (SOPs). It is fine to number the SOPs in accordance with the procedures for preparing SOPs at Investigator Site. In the case of your question, it would be acceptable to record and store the version control of the SOPs that were previously in separate volumes, along with the revision history, and to treat the newly integrated SOP as the first revised version. In this case, we think it is important to record the history of the transition from a separate SOP to an integrated SOP.