You must follow the archiving arrangements that have been agreed when receiving sponsorship.

For multi-centre trials, it is common practice for trial documents held by a Principal Investigator to be archived by their host organisation; however responsibilities should be defined in any relevant agreements prior to study start up. Researchers need to be aware of the specific arrangements for their trials.

Local instructions will need to be followed on the actual practicalities of archiving.  Some archivists require that all paper documents are removed from hard files, polypockets and have staples taken out. This is not only to reduce the amount of space required but also helps prevent degradation of the documents. It is worth noting that this will not be the same at each site therefore care must be taken to ensure that a researcher fulfils the obligations locally.

Once archived, access to the documents is controlled through special request and restricted to designated members of staff.

As the archive period nears and end, the Chief Investigator or delegate will be contacted to discuss retention or destruction of the documents.

Instructions on how to archive your study correctly can be found on our SOP and Templates page.


Study Management

 

Consent and recruitment Progress and Safety Reporting Management and Monitoring Inspection and Audit End of Study Analyse Data Final Reports