- This topic has 0 replies, 1 voice, and was last updated 2 years, 10 months ago by
.
Viewing 0 reply threads
-
Posts
-
-
I have a few questions regarding the close out of a eTMF:
* If a study will not go through an audit, what is the procedure for closing out a eTMF?
* When closing out a eTMF, is there an internal audit that is required or is that per the organization’s SOP? Who does that audit typically occur by and when?
* If a database lock has occurred, how long does the TMF team have to close out the eTMF?Thank you!
-
Viewing 0 reply threads
- You must be logged in to reply to this topic.