Trial Participant Data Record
The source of trial participant data is the data which has been entered as part of routine clinical practice onto the NBSS.
Archiving
An investigator site file will be held at each site and the relevant trial records will be archived at a secure site for 10 years.
Compliance
The CI will ensure that the trial is conducted in compliance with the principles of the Declaration of Helsinki (1996), and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework, Trust and Research Office policies and procedures and any subsequent amendments.