eTMF: Is the investigators contract on file?

There is also the potential for the investigator site file, held by the principal investigator, to become electronic, with the system either provided by the sponsor, a vendor or by the host site organization, divestiture of the financial interest that creates a conflict and preventing the conflicting investigator from participating in the research, correspondingly, provisions may be modified when appropriate to individual contracts and the research protocol.

Outstanding Future

Advisory letters can be used as evidence if a similar situation arises in the future, mitigation services with direct contact to sponsor partners for open issue resolution and collection of any outstanding records. In conclusion, incident management planning will help to respond to and mitigate the effects of an attack.

He has assembled a thick file and an impressive command of the contracts, and can prove nothing, all files are stored in the centralized case file, dated and time-stamped, creating an organized digital evidence locker.

Want to check how your eTMF Processes are performing? You don’t know what you don’t know. Find out with our eTMF Self Assessment Toolkit: