You did it!
- You saw your last patient, and ensured their safe participation.
- You completed all of the case report forms, and filed all source documents.
- You have had your study close-out visit, and the sponsor has informed you that you have fulfilled all of your duties as an investigative site.
- You have submitted the study closure report to your IRB and received their acknowledgment.
- All essential documents and correspondence are filed in your regulatory binder, or should I say binders.
- So what do you with all of it now?
The answer may vary depending on the investigative site, the sponsor, and/or the study itself. As a monitor, I recently completed a number of close-out visits and asked each site this very question. Of course the answers varied depending on institutional policy and site practices. However, there was a common theme in all of the replies I received. “We keep it forever.” Many sites were actually surprised to learn that not only is keeping records “forever” not a requirement- but how long depends on your role in the study.
According 21 CFR 56.115(d) Institutional Review Boards (IRBs) are required to prepare and maintain adequate records for at least 3 years after completion of the research. However, for an investigator or a sponsor, the answer is not so clear cut. The answer is in 21 CFR 812.140(d) and 21 CFR 312.62 which indicate maintenance of records for a period of 2 years after the latter of two occurrences:
- 1. The date when the investigation is terminated or completed, or
- The date that the records are no longer needed to support a premarket approval (PMA) or new drug (NDA) application.
Essentially, the 2 year clock starts depending on whether or not a drug or device has received approval. For example, if approval has been obtained and the study closed the answer seems clear that the records are required to be maintained for 2 years from the date study closure is completed.
In another scenario, the study is terminated or completed and approval has not yet, or may never be obtained. In this case, the answer is not so clear cut. What if the sponsor waits six months before submitting their PMA/NDA after the study is complete? What if they conduct another study that takes four additional years to complete and then pool the data with the original study to submit a PMA? In this scenario, it makes it difficult to predict just when the 2 year clock will begin. Perhaps it’s for this reason that many people keep study records indefinitely. Better safe then sorry? Most would agree that it would be better to have all the documentation and not need it, than to have disposed of something prematurely.
Whatever your role, inadequate maintenance and storage records can be costly. There must be a solution that provides good balance to meet the requirements in a cost effective manner. Do you have the answer? What is your sites policy for retaining study records? We’d love to know your thoughts on the topic.
Photo Credit: 401(K) 2013