RWE 101 – Archiving Specifics

Proper archiving of clinical study documents is an important practice for maintaining the quality, integrity, and usability of study data, and for ensuring regulatory compliance. These aspects are especially important in the context of RWE studies, where the scope and complexity of the regulatory requirements and standards, can differ significantly across and between regions. For example, here are some country-specific archiving timelines for observational drug studies:
Argentina = 2 years
Austria = 15 years
Brazil = 5 years
Germany = 10 years
Japan = 5 years
Netherlands = 15 years
South Korea = 3 years
Turkey = 5 years
According to ISPE GPP, where there are no specified national or regional requirements for retention of study materials, the archive should be maintained for at least five years after final report or first publication of study results, whichever comes later.
Additional considerations when determining what to archive and for how long, include:
[1] Legal Protection (Contractual Obligations): Archiving documents can offer protection in the event of legal questions or disputes related to the conduct of the study, data ownership, patient consent, adverse event reporting, etc. If you are a vendor, check study management contracts for any document retention obligations.
[2] Real-World Study Document Index (RWS-DI): The RWS-DI is a framework developed by a working group of real-world study (RWS) experts to address the challenges of filing essential documents for non-interventional and observational studies. Designed to be consistent with the TMF RM format and structure, but removes artifacts specific to clinical trials and replaces terminology such as “trial” with “study” and “subject” with “patient.”
In conclusion, the process of archiving clinical study documents should not be overlooked, especially in the arena of RWE studies. Regulatory compliance, data validation, legal protection, and future research potential hinge on the effective preservation of these important materials. As the rules can differ wildly from Argentina’s 2-year requirement to Austria and Netherlands’ 15 years, it’s critical to be aware of both regional specifics and overarching guidelines like the ISPE GPP’s five-year rule. Additionally, tools like the RWS-DI provide a specialized framework to ensure that archiving practices are tailored to the unique needs of RWE studies. So, when you’re next managing an observational study, remember – good archiving isn’t just about meeting regulations; it’s about safeguarding the integrity of your study, its results, and the future studies it may inspire.

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