In striving towards having an inspection ready TMF, which comprises of thousands of documents and in most cases the work of multiple parties, it is the legal responsibility of a pharma or biotech firm to have a solid grasp on the actual status of the file. By having complete visibility on how far away the reality of an airtight Trial Master File is, this provides the pharma firm with an opportunity to alter the project’strajectory if needed. This transparency can be preserved via a range of avenues which include having: solid metrics, clear oversight, frequent exchanges with the CRO and accurate understanding of the required documents.
CRO Oversight
In commissioning a CRO to manage a clinical trial, according to EU regulations the pharma or biotech firm is still responsible for the trial and so they need to retain complete oversight. Inevitably, a sponsor’s access to the TMF will be required, which is simplified by the electronic format. The sponsor will also have to decide what proofing needs to be sent by the CRO, so they can ensure the required level of documentation is obtained. Sponsor representatives need to at any given point have an awareness of the project’s progress and its level of quality. UK regulatory body MHRA clarifies that this should stretch to the presence of guidance in the organization to assist the Chief Investigator in maintaining the files via audits. The body added that outsourced workers can be held accountable with oversight documents and plans held by the sponsor’s governance department.
In Pharma IQ’s 2015 industry research, the effective management of CRO interactions – was voted as the predominant focus for the following 12 months.When outlining an oversight strategy it is wise to establish the CRO’s awareness of their responsibilities at the start of the project. This also provides a good opportunity to finalise aspects like how often documents should be uploaded, QC checks and oversight guidelines for the sponsor.
An e-tmf system, coupled with quality metrics that enable the collation of special overview reports, can provide a dashboard view to a sponsor so they can fully grasp the status of the TMF. This can reveal for example how many of the file’s 10,000 documents received spot checks from the CRO and what findings have been uncovered.