Archiving of Research Documents

Following a close of the trial it is necessary to archive all trial related documentation to ensure that all study documentation are:

  • Stored correctly and confidentiality maintained
  • Not passed on without the appropriate consent
  • Accessed in-line with Trust policies and procedures
  • Only used for the defined purpose

and to ensure:

  • Patient safety in using and recording information
  • Up-to-date information is stored
  • Staff awareness of responsibilities and accountability
  • Information is accessible when required

Storage of personal data is subject to the Data Protection Act 1998 and, in clinical trials, the applicable elements of the UK Clinical Trial Regulations.

A Standard Operating Procedure ISOP IO3 describes the procedure for the archiving of all study documents on ALL research studies that are sponsred by or hosted by North Bristol NHS Trust. The length of time for archiving is dependent upon each individual protocol and/or guidance from the commercial sponsor.