LMK was contracted by a large pharmaceutical company to ensure that all of the Trial Master File (TMF) indices (ie, regulatory submission) were present for their “high-risk” studies according to each study’s specification.
To verify TMF completeness, LMK resources performed a gap analysis on the electronic TMF (eTMF) processes using our customized electronic quality control tool—to identify potential process gaps and discrepancies. By reviewing the clinical trial SOPs and TMF Master Table of Contents, we were able to create an Indices Quality Review (IQR) process that determined which indices should be present according to the study phase, therapeutic area, and TMF type (paper, hybrid, or all electronic). After creation of the IQR process, LMK resources performed a quality review for high-priority studies identifying gaps within the TMF through missing documents. Examples of missing documents included regulatory submissions and approvals, protocol acceptance forms, training records, and periodic safety reports. Based on our findings, we discussed corrective measures with each individual study team, and the missing documentation was filed.
Our client recognized and acknowledged the gap within their eTMF study initiation process and made changes to remedy the discrepancies. During the setup of the study, the study teams now perform a series of checks to confirm that all required documentation is present. LMK’s IQR process is now a standard check that is performed throughout the life of the study to ensure that all indices and subsequent documentation is filed appropriately in the TMF.