Long Term Data Storage (LTDS) is the storage of clinical data once a study database has closed out. Following the approval of the addendum to E6 and the requirement that the sponsor should not have exclusive control of the CRF data, Datatrial now provides a long-term archive facility for data and documents so that the sponsor can demonstrate that the final data from the CRF (PDFs, datasets and other data) is stored in a secure environment. This provides assurance that your clinical data are as they were at the end of your study, and have not been modified in the interim.
How long does my data need to be stored?
Each country/regulatory board have different retention periods, so here are some of the key points for Canada, US and Europe:
- Canada: The 25 years retention period refers to Section C.05.012(4) “ …the sponsor shall maintain all records referred to in this Division for a period of 25 years.” Added clarification can also be found here: “…Sponsors may also be required to maintain records under provincial law, institutional policies, and contractual agreements with QIs, REBs or others. Where it is not possible to comply with both sets of requirements, the federal Regulations would govern and the records must be maintained for 25 years.”
- US: 21 CFR Part 312.57 states “(c) A sponsor shall retain the records and reports required by this part for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”
And 21 CFR Part 312.62 “(c) 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.”
- EU: EudraLex Volume 10 Chapter 4 Annex 6 section 2.4 “The inspection files should be maintained for at least 25 years or as determined by national requirements, whichever retention period is longer.”
The responsibility does reside with the Sponsor but extends to their contractors or vendors (i.e. CROs) as applicable.
Can I access my data once it is archived?
At any point during the data storage, a customer may request access to the files. A process must be followed by the company storing the files and the customer for any file transfer request and there must be a clear audit trail to ensure there is visibility of any person or file which has been released during the storage period.
How can Datatrial help?
Datatrial offer two types of long term data storage; cloud storage using a Microsoft Azure portal and through our platform Nucleus. The main differences between the two are Nucleus can offer an enhanced audit trail and provide user permissions so it is easier to gain access to your data. Nucleus would be chosen if access to your data on a regular basis was required.