Since 06 December 2018 the guideline on the content, management and archiving of the TMF is final and will be effective from 06 May 2019 onwards. All enthusiasts of paper TMFs should review the guideline carefully and honestly question their way of approaching TMF management over the last 20 years. Sponsors of multinational studies should consider the following requirements:
- The sponsor may choose to outsource duties and functions of the sponsor to a CRO. The sponsor remains responsible for the trial and will need to maintain oversight. Therefore, access to the CRO maintained part of the sponsor TMF or at least regular access to relevant documents from it will be necessary to fulfil these responsibilities effectively.
Do you spend the manpower, time and money to visit your CRO and their local facilities on a regular basis to maintain TMF oversight?
- The timelines for submission and filing of all documents to the TMF in procedural documents or TMF plans should be defined. This is particularly important for more complex TMF arrangements with multiple parties involved.
Where timelines are defined, timelines need to be controlled. Do you control the TMF management timelines in your TMF?
- The TMF should be managed securely at all times to ensure completeness and to prevent accidental or premature loss, unauthorized alteration or destruction of documents. Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution.
Do you know every storage location of the essential documents throughout the course of your studies? Have you visited the home offices of freelancers and homebased staff? Do you control whether the role-based permissions of accessing the TMF are kept?
- As per Article 58 of the Clinical Trials Regulation (EU) No 536/2014 “unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical TMF for at least 25 years after the end of the clinical trial.
Do you have the capabilities to archive your documentation for the prolonged period, which requires more space, more manpower and little staff turnover?
After many years of experience in conducting and auditing multinational studies including TMF auditing, we have seen a large number of paper-based TMFs, stored at different locations and facilities, maintained by a large variety of people according to different cultures, rules and timelines. At least 90% of those paper TMFs did not match with the new EMA guideline on TMF management.
Most likely, if a TMF of a multination trial is to be established and managed on paper, the required resources for the TMF will let the study costs explode. Comparing costs for storage, control and manpower of an electronic TMF with a paper TMF, is similar to comparing the costs for doing a job with a computer versus using a typewriter.
The main difference is that the typewriter has been removed from most offices 30-40 years ago. It seems that the only reason for using a paper-based TMF is a nostalgic one. Without any doubt, the transition from paper to digital systems requires resources. Nevertheless, postponing this transition will cause even greater economical disadvantages for sponsors and may significantly risk the success of clinical trials and organizations.
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