Set up and maintenance of the Sponsor File

For when an investigator/institution takes responsibility for setting up and maintaining the sponsor file

 

 

Publication Version
2.0
Publication Code
QA06
Procedure Author
WWARN

The sponsor should retain all sponsor-specific Essential Documents pertaining to a trial. However, sometimes a trial site team will maintain both the investigator site file and the sponsor file, the latter on behalf of the sponsor, and this procedure describes the process for maintaining the sponsor file.

Attachments