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?