Perhaps one of the most inconsistently fulfilled industry regulations in the world of clinical trials is the process for document management, including policies for document retention. Companies vary widely in their approach to these important aspects of drug development record-keeping despite the longstanding industry axiom that says “If it isn’t documented, it didn’t happen!”
David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider that has been successfully deploying IRT systems globally for more than a decade, has a Master’s degree in Information Science and has spent much of his career, first in large CROs, then as IRT co-owner, establishing Standard Operating Procedures (SOPs) for compliant quality control of clinical trial documentation.
“There are two clear starting points to developing SOPs for document management in CROs and Sponsor organizations: (1) know what GCPs and the FDA want and (2) know how your own internal QA interprets what GCPs and the FDA want,” Goldston says. Regulations aimed at Sponsors necessarily apply to the assorted vendors who carry out clinical trial activities on the Sponsor’s behalf.
Defining your company’s document management processes – including the use of standard filing requirements, naming conventions, a document management system that prevents conflicting overwrites, and adopting methods to ensure that you can always put your hands on the most current version of a document quickly -- is the first order of business.
“As a general rule of thumb, a successful document management system, including procedures and tools, should allow you to retrieve any document in 90 seconds or less,” Goldston says.
Equally important but less often discussed are interpretive issues surrounding document retention strategies.
According to ICH-GCPs: “The sponsor specific essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirement(s) or if needed by the sponsor.
The FDA in 21CFR Part 312 says this about record retention: “An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.”
It is immediately obvious that the exact ‘end point’ for retention requirements is not hard-set for vendors (even less so than it is for Sponsors who at least have some measure of control over a drug’s fate). Vendors are required to adopt strategies that put them ‘on the safe side’ of whatever happens with a drug investigation in a potentially open-ended environment.
Other requirements can add another layer of complexity. For example, in addition to GCP requirements, the Finnish Medicines Agency Regulation 2/2012 requires that original trial documents must be stored for at least 15 years after the end of the trial. The records retention schedule of patient files is governed by the relevant general provisions and regulations. Trial registers are governed by the provisions of the Personal Data Act.
Some industry document storage experts – for example, Iron Mountain – offer retention guides by country.
But there are forces other than regulatory considerations that impact a vendor’s document retention policies.
“For instance,” Goldston says, “there’s zero possibility that we will not archive for the life of the company a copy of each IRT system we’ve ever produced and all the internal project documentation (e.g., specifications, change orders, etc.) related to it. This is to be able to recall these things at any point we might be required to, as expected by the industry, both for referral and for any potential evidentiary situations.
“As a vendor you must develop plans for how long you will keep paper/wet ink, electronic records, and backup media. There may be different retention periods for each category. At Veracity Logic, we keep physical backup media and paper/wet ink for 7 years. Scans of those documents are kept for the life of the company. Of course, the originals of wet ink, client-facing documents are sent to clients in real time throughout the study, and electronic records can made available to clients via secure portals such as ShareFile at throughout a study. We keep all electronic records for the life of the company.”
Here are a few pivotal guidelines to keep in mind when developing a retention policy:
- Clearly define retention periods for each document category (i.e., electronic, wet ink, DVD/CD-ROM, etc.) in a formal SOP.
- Be sure to faithfully follow your retention schedule! This includes developing processes for ensuring that document destruction will be accomplished in the timeframe specified in the SOP – for example, within 90 days of the target destruction date.
“It is extremely important that you stick to your plan,” Goldston says. “Legal issues can result if documents are destroyed too early or too late. For example, you never want to accidentally give the impression that you may be destroying records for some inappropriate reason (like coincidentally destroying documents just before an audit or just after a lawsuit of some sort has surfaced in the industry!). If you stick to your documented schedule, no one can infer nefarious intentions. If your SOP says you will destroy X in 7 years from effective date, do it!” Caveat: if there is pending litigation related to documents scheduled for destruction, you must delay destruction of the documents until the litigation is resolved.
- Make sure your Non-Disclosure or Confidentiality Agreement with clients includes a clause that all materials will be returned to them at study end with the exception of an archival copy that is incorporated into your routine backup procedures.
- Remember to consider any and all international requirements (by country) which may aid your thinking about how long to retain documents.
Share this Post