Essential Documents
Thorough and efficient management of essential documents is an important practice throughout a trial, from start-up to close out. CRDO has developed the below resources to help both sponsor and site teams for IITs to manage their essential documents and creating uniform filing structures across sites.
The electronic management of essential documents for clinical trails is complicated space as data and privacy laws, along with GCP and GDPR, require electronic trial binders to meet rigorous standards. MCRI sponsored trials that wish to file digitally are encouraged to use Florence eBinders. Florence eBinders is a cloud-based platform design for clinical trials. It is a research eBinder platform that can manage TMF, SIF and ISFs for single and multi-site MCRI IITs. To find out more about Florence capabilities and use at MCRI visit MCTC Florence Binders.
A Trial Master File (TMF) is a filing repository controlled by the Sponsor/Sponsor-Investigator. It is the collection of essential documents that allows the Sponsor responsibilities for the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with Good Clinical Practice (GCP) to be evaluated.
Paper TMF filing guidance
MCTC012 Guidance | Trial Master File (TMF) Table of Contents Document Filing
MCTC119 Template | TMF Table of Contents
MCTC120 Template | TMF Paper binder section dividers
Electronic TMF filing guidance
A subsection of the TMF contains duplicates of site-specific essential documents required for the management of the trial, these are the Site Information Files (SIF).
Paper SIF filing guidance
MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
MCTC115 Template | SIF Table of Contents
MCTC116 Template | SIF Paper binder section dividers
Electronic SIF filing guidance
An Investigator Site File (ISF) is a filing repository controlled by the site Principal Investigator. It is held at the trial site and contains all the essential documents necessary for the site trial team to conduct the trial as well as the essential documents that individually and collectively permit evaluation of the conduct of the trial at the site and the quality of the data produced.
Paper ISF filing guidance
MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
MCTC117 Template | ISF Table of Contents
MCTC118 Template | ISF Paper binder section dividers
Electronic ISF filing guidance
MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials