GCT has been selected for eTMF setup and maintenance for a clinical study in the US and rest of world (ROW). GCT will perform activities to ensure a smooth merge of the TMF between US sites and ROW. The Phase I/II study has been ongoing in the US for over five years in 45+ sites. At the time, a paper TMF was implemented, however the Sponsor would now like to transition the paper files to an eTMF.
Our team will transfer the files from paper TMF to eTMF to ensure an audit ready Trial Master File. We will check that all files were correctly maintained to identify and resolve any issues. GCT’s responsibilities include but are not limited to maintaining electronic files and original paper copies — where necessary, related to study sites and to third-party vendors contracted by GCT, as well as study-related regulatory Essential Documents and safety-related documentation. The GCT team will be responsible for obtaining, collecting, labeling and filing all documents in the eTMF following an initial QC. Our Project Manager will be also responsible for the regular review of the TMF content.
Once study documents are uploaded
to the appropriate section of eTMF, they will be kept in a secure area with
limited access. All documents will be readily available and directly accessible
for audit purposes.
The selected eTMF system is fully validated and meets compliance with 21 CFR Part 11 and other global regulations. It is available 24/7 from anywhere in the world. Having an eTMF ensures constant inspection readiness by means of automated folders completeness statistics, missing documents reports and various notifications. The validation process is based on GAMP methodology. Fundamental to successful validation technical security and 21 CFR Part 11 required controls are implemented in the system.