Regulatory Binder Templates for Logs, DSMP, and other Inserts
Study name: Study PI:
Study ID #:
This is a log of important communications between the site and those external to the site, such as FDA, the sponsor, etc. You may decide to maintain a separate communication log for each type of communication, so that, for example, all FDA communications would be on one sheet, etc. or you may use only one main log for a listing of all communications.
representative name, affiliation
BUMC Clinical Research Study Regulatory Binder Tab Inserts Version 7/1/08