The project tasks were to receive the Trial Master Files (TMFs) for two European studies from the Sponsor and two (2) CROs, consolidate each TMF into a separate file, inventory each file to ensure that all Essential and Regulatory Documents were present, scan each compiled TMF to a portable document format (pdf), and file documents electronically to replicate the hardcopy TMF. The TMFs included all documents as defined by ICH Topic E6 §8.0 (e.g. Protocols and Amendments, IVRS Files, Monitoring Files, Investigator Files, Data Management Files, etc.).
While the TMFs were in-house, Advarra also supported the compilation of CSR appendices by the CRO, provided Project Management expertise, tracked all activities, and provided updates to the Sponsor.
Small specialty biopharmaceutical company involved in the conduct of global clinical trials using an approved and commercially available product worldwide.
The Sponsor purchased the compound while multiple US and EU studies were in progress. Challenges arose with the oversight of the CROs as well as the maintenance of the previous Sponsor’s TMFs. As the studies were being closed, the Client had concerns about the integrity of the previous TMFs and did not have internal knowledge of ex-US requirements. In addition, the Sponsor did not have the physical space or resources to complete the reconciliation of the files.
Advarra assigned dedicated inventory, scanning/electronic filing and Quality Control teams. A standardized TMF index and naming conventions were generated collaboratively with the Client. TMF sections were reviewed for completeness and re-filed according to the TMF index. The sections were scanned into an electronic format. The electronic documents were named according to the TMF naming conventions and electronically filed according to the TMF index. All electronically filed documents were entered into a Master Tracker with hyperlinking capabilities; the Tracker served as the TMF table of contents for the hardcopy and electronic TMF. Each scanned and tracked TMF section was boxed for archived off-site storage with complete inventory capabilities. Missing documents and/or deficient sections were listed and provided to the Client for follow-up with the CRO. As requested by the Client, documents were provided to the CRO for use in the CSR appendices. All activities were accomplished on-time and under budget.
A quality assurance sampling of documents and sections were reviewed to ensure that the selected document/section was reviewed, inventoried, scanned, and filed (electronically and hardcopy) according to the TMF index and naming conventions. After all activities were complete, the Master Tracker was updated with the appropriate box number, the boxes were sent off-site for archival, and the electronic files (including the Master Tracker) were copied to DVD and delivered to the Client, and the Master Tracker was also uploaded to the Client’s server.