How long do you have to keep research data?
Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) and UVA regulations require that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan.
How long should you keep data for?
You should consider any relevant industry standards or guidelines. For example, we have agreed that credit reference agencies are permitted to keep consumer credit data for six years. Industry guidelines are a good starting point for standard retention periods and are likely to take a considered approach.
What is a TMF plan?
This plan outlines how records for the trial will be managed and stored during and after the duration of the trial, including study specific processes and documentation for archiving and destruction. All relevant study team members are expected to understand and adhere to this TMF Plan.
What is a clinical trial master file?
The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed.
What are CRO services?
A Contract Research Organisation, also called Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).
Why is TMF important?
The reason why the TMF is so important is that it permits the study to be independently recreated from these study records. TMF is a quality process, allowing to document all of the activity that has been performed during the study.
What does ISF mean in clinical trials?
An Investigator Site File (ISF) should be established at the beginning of each clinical trial. The ISF contains the minimum list of essential documents that have to be maintained throughout the clinical trial.