The development, handling, filing, and archiving of essential documents is an interdisciplinary task and cannot be allocated to a specific department or function. Why not? Because the term ‘essential document’ comprises many different documents with varying content and usage. The documents will be developed by various persons or functions, e.g., medical writer, data manager or CRA, at different stages of the clinical trial. However, to all these essential clinical trial documents, the same principles apply.
Against this background, you as a sponsor should consider the following key aspects:
- Standardization on a company level at the CRO.
- The CRO should have processes implemented covering the life cycle of essential documents. The more standardized the approach is, the less room will be left for insecurities and pitfalls. It should be obvious, that the CRO should be able to provide evidence that all affected personnel were trained on these processes and their documentation.
- Adequate filing in an electronic or paper Trial Master File (TMF).
- Paper TMF? So old-fashioned! But - is that really the case? If you have the CRO using an electronic TMF (eTMF), it is important to know that some relevant guidelines need to be respected, such as e.g., EMA/INS/GCP/856758/2018 and EMA/INS/GCP/112288/2023. That might be regarded as a manageable task when it comes to filing during the study conduct. But please consider that for the archiving period of up to 25 years, adequate provisions need to be implemented, and these also must be guideline compliant.
- Ensuring that investigators have their Site Files adequately maintained.
- According to the Clinical Trials Regulation and guideline EMA/INS/GCP/856758/2018, the Investigator Site Files, ISFs, are part of the Trial Master File. Consequently, they are named as ‘Investigator TMF’. As a sponsor you should make sure that the investigators involved in your clinical trial are aware of their responsibility to maintain the Investigator TMF. The CRA will verify that the Investigator TMF is adequately maintained and complete, but the responsibility for the correction of the CRA’s observations will always remain with the investigators and their teams.
Interested in optimizing your clinical trial processes? Learn more about our comprehensive services tailored to meet your needs. Contact us today for a consultation.
Autor: Dr. Christoph Ortland, January 2024
Wollen Sie mehr über Forschungsdock erfahren?
Nutzen Sie gern unser Kontaktformular. Wir setzen uns umgehend mit Ihnen in Verbindung.