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.

In the context of health research, both observational studies and clinical trials are crucial for understanding disease processes, patient outcomes, and the safety and efficacy of treatments. However, due to varying regulatory requirements and standards, the archiving requirements for these types of studies are distinct. Here are some of the key differences:
 
[1] Regulations and Guidelines: Clinical trials as governed by a global set of ethical and scientific standards, such as ICH GCP. These standards are then adopted into law in different regions, say for instance, through the Regulation EU/536/2014, and 21 CFR 312 in the US. These rules are clear about how to manage, store, and archive data and require specific documents to prove the integrity of the trial data. They also set out how long these crucial documents should be kept (e.g., at least 25 years).
 
On the flip side, observational studies aren’t governed by such unified requirements when it comes to document retention and archiving. They still follow ethical guidelines and good practice principles like the Declaration of Helsinki, ISPE GPP, and STROBE guidelines, but these may not give you exact retention times or archiving mechanisms.
 
[2] Data Collection and Confidentiality: Clinical trials are data-rich; they collect a large amount of confidential and sensitive patient data. Regular sponsor audits and regulatory inspections mean they need to keep robust records. Observational studies, while they also handle sensitive data, usually don’t interact with patients as much and don’t face as many regulatory inspections. So, they’ve traditionally not had to maintain as meticulous records.
 
[3] Data Accessibility: Clinical trial data is often more restricted in terms of who can access it and how it can be shared. This is due to both regulatory needs and commercial interests. Observational data, though, is often used for big-picture disease studies, and it’s usually designed to be more shareable – as long as it’s anonymized and ethical procedures are followed.
 
It’s important to remember that what I’ve explained are general patterns. The exact requirements can change based on region, the type of data you’re dealing with, and even who’s funding your work. If you need specific guidance, don’t hesitate to reach out to an expert or regulatory authority in your area.