Module 12 2019

TMF Process Flow

Manage Sponsor File Throughout trial

Initiate Sponsor File

Close Out TMF

Conduct Final Completeness and Accuracy of TMF

Collect and File Records in Sponsor File Within Given Timelines

Initiate Sponsor File Initiate Using List of essential elements

Communicate List of Trial Related Expected Records

Apply Good Document Practice for all Records

Move TMF to Archive

Remediate Issues

Conduct Completeness and Accuracy of Sponsor File

Report on Status of Sponsor File

The Organisation for Professionals in Regulatory Affairs