The Investigator is responsible for the conduct of the research study. As a condition of Management Approval the following information is required to be submitted to R&D during the lifespan of the project:
Investigator Site File All research studies must have a site file to aid in document storage and management of the research study. The site file should contain all essential documents required to be stored at site and retained for five years following the study end (CTIMPS only). Please download an Investigator Site File template here.
Progress Reports The Chief Investigator (CI) must submit an annual progress report each year to Ethics. More information can be found at National Research Ethics Committee (NRES). R&D must also be supplied with a copy of the report made to ethics and the Principal Investigator (PI) must inform R&D when the study ends.
Safety SAE Reporting (CTIMPS only) CTIMPS sponsored by NHS GG&C or co-sponsored with The University of Glasgow The PI should ensure that all members of the research team are familiar with GCTU SOPs for Pharmacovigilance available here. Further information on the SAE/SUSAR reporting procedure and services provided by the PV office including assistance with the preparation and submission of Annual Safety Reports are available here.
CTIMPs hosted by NHS GG&C Adverse events must be recorded, assessed and reported as specified in the study protocol. SUSAR Reports and Annual Safety Reports must be provided to R&D as per the conditions of Management Approval. Further information available here
Safety Reporting (Research other than CTIMPs) The NRES has specific reporting requirements for safety reporting in research other than CTIMPs. Details are available here