Would Your eTMFs Pass an Audit?
The popularity of Electronic Trial Master Files is growing rapidly; in 2010, 50% of respondents to a survey said they maintained TMFs in paper only. Just two years later, in 2012, that number dropped to 32%. In addition, the number of survey respondents who maintained inspectable eTMFs and paper TMFs increased from 27% in 2010 to 48% in 2012, showing a significant increase in just two short years.
So, it’s clear that a strong transition to electronic trial master files is underway.
There are many benefits to using eTMFs, but it also requires new work procedures and methods. One of the most critical is the way companies handle agency audits; with paper TMFs, investigators must make sure that all paper records are available. The same holds true with an eTMF, along with several additional concerns that must be addressed.
Check Your Records against this Trial Master File Audit Checklist:
- All records in the eTMF must be secured against alterations and unauthorized access at all times.
- A validated quality control process must be used when paper documents were scanned and uploaded to ensure final records are legible and complete.
- A system should maintain records to validate that this process was followed.
- All documents in a study should define the quality control process.
- If any expected documents were not received, justification must be provided.
- Any and all significant actions must be recorded in an audit trail; this trail must be understood by auditors and users.
- If there are associated paper records, they must be retrievable and preserved, unless a certified process is in place for their destruction.
- The entire, complete TMF needs to be available, including paper documents and electronic ones.
- Record retention policies must be documented and followed.
- Inspectors should be able to access all electronic trial master files using a user-friendly interface.
- Records must be indexed in a way that is clear, showing that all essential documents are present.
- Validation records for the system must be made available.
Begin with the End in Mind!
The best way to ensure your eTMFs meet these criteria is to consider each tip when TMFs are first designed and implemented. It is critical that you ensure the readiness of the eTMF for audits. Quality control must be standard – never optional. Confirm that all reports and queries provide a catalog of all documents comprising the trial master file, and be sure to reveal any documents that are missing or those that have not passed/completed quality control processes.
What Else do the Authorities Want?
Auditors are willing to conduct audits in an eTMF environment, and they expect you to take the necessary steps to provide them with everything they need to complete the audits in a timely manner. Checking your system against this trial master file audit checklist will ensure that this happens.
Learn more about eTMFs in our upcoming Trial Master File conference – click here for information.
