All requests to undertake clinical research in the Imperial CRF must be approved by the Protocol Review Board (PRB), consisting of the CRF Director, CRF Head of Clinical Research, CRF General Manager, CRF Lead Nurse, and non-ICRF members covering toxicology, clinical pharmacology, pharmacy, safety and medical statistics. Further information can be found in our Application SOP. The PRB meets twice monthly and requires the following information:
- A copy of the research protocol
- Completed ICRF Application form v 7.2
- Completed ICRF-OR09 Fm 3 v4.2 Clinical Risk Assessment and Management Plan“>Clinical Risk Assessment and Management Plan for all CTIMP studies
- Completed ICRF Phase I Additional Information template for Phase I studies. Phase I studies will only be reviewed at the second PRB per month
- PI and lead researchers’ CVs
An electronic format for each document is required and this should be e-mailed to the CRF General Manager at least one week before the next PRB meeting. The dates of the upcoming meetings can be found here. The PI and/or the key trial coordinator of the study will be invited to the relevant PRB meeting and will be given the opportunity to introduce their study and discuss their application with the Board. Further reading on our SOP’s can be be found here.
The project will be assessed according to the:
- Scientific value of the question asked
- Availability of resources, including access to appropriate numbers of subjects
- Existing activity within the CRF
The outcome of the meeting will be forwarded to the PI within 5 working days of the PRB meeting.
For further enquiries about the PRB process, please contact the CRF General Manager.
For further information on