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Post Approval

Congratulations, your research study has Management Approval! What happens next? R&I will ensure that all research studies are carried out in line with national guidelines as described in the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and other relevant government legislation.

Once R&I has issued Management Approval the Investigator is authorised to proceed with the research study. R&I is then responsible for research management and governance of the research study and will require updates on recruitment, study progress and will approve all study amendments throughout the lifetime of the study

NHSGGC responsibilities

Once R&I approval has been issued NHS GG&C has responsibility for:

  • Ensuring investigators perform pharmacovigilance to required regulatory timelines as dictated by government legislation (CTIMPS only)
  • Ensuring research teams are working to GCP standards as required by the EU Directive and Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended) (CTIMPS only)
  • Following the trial to completion and ensuring regulatory requirements are met for the termination and final reports are submitted to ethics and/or the regulatory authority
  • Capturing publication and dissemination, service benefits and other key research outputs

Multi-site Studies Where a research study is being extended to sites outwith GG&C to other NHS organisations, R&I will generate multi-site agreements which set out the responsibility of each party. R&I regularly organise international trials which have global sites round the world, e.g. U.S.A, Australia, France and Japan.

Monitoring R&I has a responsibility to monitor research studies conducted on its premises under ICH-GCP, the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and the Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended).

Investigator responsibilities

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&I 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&I must also be supplied with a copy of the report made to ethics and the Principal Investigator (PI) must inform R&I 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&I 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

Amendments

Amendments made to any study specific documentation must be reported to ethics, the MHRA (if the research study is a CTIMP or medical device) and R&I. The NRES require changes to studies to be reported with those deemed substantial to be approved. Guidance on whether an amendment is substantial or non-substantial can be found here. Please submit the following documentation to R&I to ensure management Approval of your study is still valid:

  • Copy of the Notification of Amendment form sent to ethics
  • Copy of the favourable opinion of the amendment from ethics
  • Copies of all documentation listed in the amendment favourable opinion letter received from ethics
  • Copy of amendment approval letter from the MHRA (only required for CTIMP or medical device).

Once the above documents have been satisfactorily reviewed by R&I you will receive an email confirming R&I Approval is still valid