Archival of Clinical Study Records
As per the New Drugs and Clinical Trial Rules (2019) and Good Clinical Practice Guidelines by CDSCO, all essential documents pertaining to a clinical trial must be archived. It is the responsibility of the sponsor to ensure that the documents and trial supplies are archived for at least three years after the completion of the trial, or submission to the regulatory agency; whichever is later. In addition to essential documents and trial supplies, the sponsor may have specific archival policies pertaining to each study and hence the archival plan must incorporate these specifications as well. For instance, the sponsor may retain the documents for a longer duration. Archival is a key requisite to ensure post-trial monitoring, evaluation, and to facilitate further research.
In certain instances, the regulatory authority and/or the ethics committee may recommend a timeframe for archiving of documents for a clinical trial, at the time of granting an approval.
The regulatory agency and/or the sponsor may request the investigator to archive certain essential documents for longer than the specified period. The sponsor should notify the investigator / institution in writing, when the trial related documents are no longer required to be retained. The investigator should ensure that these archived documents have restricted access and are secured in a location that maintains their integrity.
We at Consortium Clinical Research, have established necessary Standard Operating Procedures (SOPs), infrastructure, and a trained team to serve our clients in terms of archiving Clinical Study Records as per relevant guidelines.