In the context of clinical trials, the end of study transfer is a crucial process that involves the transfer of various study-related documents, data, and materials from the sponsor or contract research organization (CRO) to an appropriate entity or repository for long-term storage and archiving.
Clinical trials generate a significant amount of data, including patient data, study protocols, case report forms, and other documents that are critical for the integrity, transparency, and reproducibility of the study results. Proper long-term storage of these data ensures that they are securely preserved and can be accessed for future reference or regulatory purposes. For example, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines on the retention of essential documents, including long-term data storage, in its Guideline for Good Clinical Practice (GCP). Additionally, regulatory authorities such as the FDA have specific regulations on the retention and archiving of clinical trial data, including requirements for electronic records and signatures.
Yet despite its importance, very few emerging life sciences organizations plan ahead for the end of study transfer of the electronic trial master file (eTMF), often breaking the audit trail and putting them out of compliance.
Here is a scenario a Kivo customer navigated recently:
Brian, the Director of Regulatory Affairs at a small biotech company, was notified by the regulatory inspection agency that the company’s investigational therapy had been selected for approval contingent on a review of their Phase IIb trial. The agency informed Brian that they would be scheduling an on-site visit to carry out the inspection in the coming weeks.
Immediately after receiving the notification, Brian notified his colleagues, Lisa, the Clinical Project Manager, and Nicole, the Document Management Specialist. Although the Phase IIb trial was outsourced to a CRO, their company had acquired the Trial Master File (TMF) back from their CRO at the end of the study years ago. The team developed a plan of action and began preparing for the upcoming inspection.
Nicole informed Lisa that the trial documentation was stored on a thumb drive at Iron Mountain, so she placed a request for it to be retrieved from storage. The next day, the thumb drive arrived at the office. At that point, Nicole realized that her new computer did not allow her to use the USB port and she needed to contact IT for support. Once IT enabled her USB port, no one was able to find the e-mail containing the encryption key since the TMF transfer from the CRO was handled by an employee who had since left the company.
Brian and the team realized they were now at the mercy of reaching out to the CRO, hoping they can help. They worried about the possibility that the CRO might no longer have the encryption key or might have no record of the TMF.
As you can see, a poorly managed end of study transfer can jeopardize the many years and thousands of hours of work that go into a clinical trial. It is important for sponsors, CROs, and other stakeholders involved in clinical trials to be aware of all relevant regulations and guidelines and ensure that proper procedures are in place for the end of study transfer and long-term data storage.
Below is a list of best practices to follow when managing an end of study TMF transfer:
- Establish your end of study TMF transfer plan early with your CRO, and create a cadence for regular communication
- Include in your plan all the quality checkpoints required before, during and upon completion of the TMF transfer
- Determine the scope of the TMF transfer and define what needs to be transferred (all essential documents and data records stored in the eTMF as well as content from ancillary systems, make sure you capture e-mail chains where applicable)
- Establish a timeline for your transfer and account for time needed to check the contents of what is transferred
- Assess the quality of your TMF prior to the transfer and check for completeness and correctness of data and associated metadata
- Ensure audit trails are captured and preserved in your eTMF of record
- Record and document the transfer process for regulatory compliance and ensure that all changes or alterations to the TMF are traceable
- Chose a secure and compliant method for the data transfer i.e. SFTP
- Perform thorough QC on the transferred data
- Choose a fit-for-purpose eTMF system that is validated and streamlines workflow with built-in security, searchability and supports inspection-readiness
- Make sure your system supports long-term storage of the eTMF according to regulatory requirements
- Consider reaching out to your eTMF vendor for support with the TMF migration process
- Don’t sign off on finalization of delivery until you have completed a thorough quality check (QC)
- Don’t accept files that are encrypted – unless you have the key and can secure it for later access
- Make sure all files are uploaded to a validated system
Most importantly, don’t wait till the end of the study to plan for the TMF transfer. And if you need support, we at Kivo are here to help.
