Trial Documentation Systems

Designing efficient record keeping systems facilitates documentation of trial related activities and improves readiness for audits and inspections.

Accurate and timely documentation of trial processes is critical for managing clinical supply chains. This also ensures that the records are available for audits and inspections. Since Vital Strategies managed the trial supply chain, all records related to procurement, shipment, storage, relabeling, dispensing, returns, and disposal of IMPs had to be maintained in the Trial Master File (TMF) and site pharmacists maintained records in Pharmacy Site Files. Regular filing of documents in the TMF and Pharmacy Site Files by Sponsor pharmacists and site pharmacists, respectively, should be part of daily routine despite the fact that it is time consuming and tedious. As the TMF requires documentation for all sites, having a dedicated staff member to manage the TMF can also help ensure that it is accurately maintained.

The most efficient process for maintaining the TMF emerged as the trial progressed. Records were generated by Sponsor pharmacists, the site pharmacists, or they were received from suppliers as required. World Courier, the logistics organization we partnered with, stored substantial quantities of IMPs and provided access to their stock management database so the status of incoming shipments, stock levels at the intermediary storage depots, and status of outgoing shipments could be documented in real time. All purchases and shipments were recorded in an electronic tracking sheet and electronic and hard copies of the files were maintained in the TMF. However, early in the trial, these processes were not in place. For example, not all IMPs were transported via intermediary storage depots, especially in Stage 1. Additionally, during Stage 1, a consolidated database of purchases and shipments was not maintained and only electronic records for individual purchases and shipments were created. It meant that the system was not as efficient as it needed to be, and previous records had to reconstructed and filed.

Recommended best practices

Efficient record keeping systems should be put in place with the following measures:

  • Records on movement of IMPs from suppliers to participants should be maintained throughout the trial

  • Validated and secure electronic systems to document the supply chain from procurement to dispensation of IMP to trial participants should be available

  • All documents should be filed in the TMF and Pharmacy Site Files on an ongoing basis to ensure the trial is ready for any audits or inspections

  • Have a dedicated staff member to maintain the TMF