How to avoid Trial Master File-related inspection findings - TMF guidance explained

Recording of the 2hr webinar held in April 2022, plus additional time if required to answer participant’s questions.

The course highlights key inspection findings relating to TMF and then goes on to use the EU TMF guideline as a template for good TMF structure and management. A number of questions are addressed, as if being challenged by an inspector
 

• Why is getting the TMF right so important?
• What makes up your entire Trial Master File?
• Where are all of your TMF documents located?
• What documents are not filed in the TMF?
• Do you have documentation that ranks the importance of your e-systems?
• Does your documentation allow me to reconstruct the trial conduct and show compliance with the protocol and GCP?
• Which documents do you segregate in your TMF and how do you do that?
• Are your documents filed chronologically?
• How do you deal with documents common to several trials?
• Do you have a standard TMF checklist? – highlights that a standard checklist is not feasible and needs to be trial specific
• How do you handle draft documents?
• How do you handle superseded documents?
• How do you manage correspondence in the TMF?
• Tell me how you deal with emails? – brings in need for metadata
• How do you deal with copies of TMF documents? – brings in certified copies
• Do you ensure metadata are retained when transferring documents?
• How do you document management and oversight of your vendors?
• How and when do you file documents to your TMF?
• How and where do you store your TMF? Have you documented a risk assessment for this?
• What controls do you have in place for your e-systems and e-TMF?
• How do you QC your TMF?
• Do you have a policy for destroying documents after scanning?
• What arrangements are in place for the retention of your TMF?
• What impact has the pandemic had on TMF management and documentation?
• What are the requirements for getting remote approval of documentation?
• What processes are in place for the oversight of the TMF?
• Is your TMF always inspection ready?
• Optional section: Protocol deviations and the TMF.
• Case study on document data integrity.

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