Updated retention good practice guidance
"The sponsor and investigator/ institution should retain the essential records in a way that ensures that they remain complete, readable and readily available and are directly accessible upon request by regulatory authorities."
Specified retention periods and requirements.
Given the ICH’s global outlook, the guidelines are pretty clear when it comes to retention periods. In short you need to refer to specified local requirements, both where the trial was run, and where you may want to sell the drug into in future.
So for example if a trial is conducted within the European Union, or will be sold into it, you need to adhere to EU CTRs 25-year retention period.
In terms of more specifics about how stakeholders should retain records, we can look to section C.2.6 of the appendix which states:
"The sponsor and investigator/institution should retain the essential records in a way that ensures that they remain complete, readable and readily available and are directly accessible upon request by regulatory authorities, monitors and auditors. Alteration to the essential records should be traceable."
Here we can see clear reference to several of the ALCOA++ principles. We’ve written extensively about these here if you would like to know more about their application to long-term retention.
What is interesting to highlight from the above quote, is that when combined with the previous point about the scope of essential records that should be retained, sponsors and investigators need to approach long-term data management very carefully.
Given many organisations typically retain these records in different systems (either in file sharing platforms, home grown archives or kept within source systems), there is a significant risk posed to long-term access and availability.
I would also argue that it strengthens the case significantly for consolidating all essential records related to a trial into a single and centralised repository – or as ICH E6(R3) refers to, a ‘retention system’. This not only makes providing access to inspectors, auditors and monitors much easier, but also enables organisations to actively manage the data over the entire retention period, and importantly, to ensure that it is complete and readable for the full lifecycle. That’s not even including the capturing and maintenance of complete audit trails for traceability.
Finally, I think it's worth noting a small change to C.2.6 between the draft and finalised guidelines. In addition to regulatory inspection, auditors and monitors were also added to the section. Coupled with the definition of an audit within the glossary, it includes examples such as a sponsor auditing a site or monitoring a CRO. Therefore, it makes sense for C2.6 to change to say that retained records should be accessible to anyone who needs to audit them and not just regulatory authorities.
"The sponsor (or subsequent owners of the data) should retain all of the sponsor-specific essential records pertaining to the trial in conformance with the applicable regulatory requirement(s)."
‘3.16.3 Record Keeping and Retention’
"...not only should the sponsor set the retention period for the site...they should also provide guidance how those records should be retained."
Retention responsibilities for sponsors and investigators
There is a lot of coverage within R3 of the responsibilities and interactions between the sponsor and the investigator/site. From a retention standpoint, several things stand out.
Firstly, when it comes to retention expectations, they are treated the same. Both must adhere to the same requirements that we have referenced throughout the post; we can see this in the above quote (C.2.6) which specifically mentions both.
That said, R3 makes it clear that it is the sponsor who is responsible for setting the overall approach for retention. We can see this in the two quotes below;
2.12.12: "The investigator/institution should retain the essential records for the required retention period in accordance with applicable regulatory requirements or until the sponsor informs the investigator/institution that these records are no longer needed, whichever is the longest. The investigator/institution should take measures to ensure availability, accessibility and readability and to prevent unauthorised access and accidental or premature destruction of these records (see Appendix C)."
3.16 g: ‘The sponsor should provide guidance to investigators/institutions, service providers and trial participants, where relevant, on the expectations for data capture, data changes, data retention and data disposal’
So not only should the sponsor set the retention period for the site (based on their own requirements), they should also provide guidance how those records should be retained. This puts a strong emphasis on the sponsor taking the strategic lead on retention.
It's also worth noting a small change/merging of points here between the draft guidelines and the finalised version. The second half of 2.12.12 has been expanded or moved from other points to specifically reference availability, accessibility and readability, in addition to the prevention of unauthorised access and premature destruction of records within the same section.
"...it is the sponsor who is responsible for setting the overall approach for retention."
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