Files need to be prepared for storing the essential documents for a clinical trial. A Trial Master File (TMF) is held by the sponsor and Investigator Site Files (ISF) are held at sites participating in the trial. The TMF and ISF can be hard copy or in an electronic format.
If the trial is using a drug, then a Pharmacy File is used to ensure appropriate records of the trial drug are kept.
TRIAL GUIDELINES
Guidelines and/or user manuals are required to instruct clinical trial staff on operational aspects of clinical trial management, e.g. collection and entry of trial data; receipt, storage and handling of investigational drugs; collection, processing and storage of biological specimens.
For example:
You and the Sponsor should also determine how the trial should be monitored and this should be documented in the monitoring plan in the protocol.
If you wish to provide feedback or contact the team at the NSW Regional Health Partners Clinical Trials Roadmap please email ctroadmap@hmri.org.au
New South Wales Regional Health Partners respectfully acknowledge Aboriginal people as the past, present and future traditional custodians of the land and recognise their continued connection to land, waters and culture. We aim to partner with the Elders, community members and community controlled health services to improve health outcomes for Aboriginal people.