Outsourcing the TMF: 5 Vendor Qualities for a Successful Remediation

November 4, 2015

  • eTMF Resources

Proper TMF QC and remediation can be a strain on organizations with limited resources. To ensure these processes are properly managed, many organizations outsource to clinical trial service vendors. Skilled vendors can ensure a TMF is complete, compliant, and consistent in a timely manner. However, unskilled vendors can further complicate and extend the review process thereby extending critical study/regulatory submission timelines.

Sholeh Ehdaivand, President and Chief Executive Officer of LMK Clinical Research, shared with us five key qualities to look for when choosing a TMF QC and remediation vendor.

  1. Experienced TMF resources

TMF QC is not just a review of documents; it is a review to confirm that all of the content is a proper reconstruction of the clinical trial. In order to perform TMF QC and remediation, the resource has to have a thorough understanding of clinical trials. The TMF is the only evidence that we have to prove that we protected our patients’ safety. If the evidence is not present and in proper order and the person performing QC does not understand what to expect and the order, then the TMF will not be complete and compliant.

Vendor resources should all have at least two years of direct clinical trial and TMF (which includes records management) experience. In addition to records management skills, TMF QC specialists must know how to QC against what is expected, rather than just what is present.

2. Understanding the SOPs that were followed during the study

Standard Operating Procedures are a good indication of how a company manages their clinical trials. In addition to ICH GCP and regulatory requirements, the SOPs can help vendors determine what company specific documentation to expect. For example, if a company’s SOPs require a full CV of all their principle investigators, it is important to know and understand that requirement before for starting a TMF QC project.

3. Understanding the study

No two studies are alike even within the same company. There are always some protocol variations. In order to fully understand the TMF, the vendor must understand the study. For example, did the study utilize a Data Monitoring Committee? Is it a first human trial? These are just a few examples, but when a third party is reviewing the TMF, it is imperative to understand the study specifics to understand what should be expected in the TMF.

4. Proper oversight

It is crucial to maintain consistency when performing QC and remediation. The vendor should be able to provide documentation of their oversight process (to ensure consistency amongst their reviewers). The vendor should be able to confirm the policies/processes they have in place to ensure proper oversight of their QC and remediation resources. For instance what constitutes a pass? A fail? As the client, do you understand the criteria that the vendor is utilizing and are you in agreement.

5. Timing

As we learned in last week’s blog post, identifying issues and following up on them immediately is the best way to ensure successful remediation. The longer discrepancies are pending and outstanding, the more difficult it becomes to resolve. Choose your vendor early on in your trial, and make sure they allocate enough time to perform TMF QC and remediation.