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SOPs and guidance relevant to CI’s for studies (other than ATIMPs, CTIMPs and medical device studies) which are sponsored by UCL or UCLH and managed through the JRO (only).
SOP for Reporting Research Incidents and Events in non-CTIMPs
- AE Log
- SAE Log
- Protocol Deviation Log
- Protocol Violation Log
- Participant Screening Log
- Participant Enrolment/Withdrawal/Completion Log
SOP for Peer Review for studies sponsored by UCL and UCLH (Last updated 11/12/2023)
- Guidance for Researchers: JRO Peer Review Requirements for UCL/UCLH Sponsorship
- UCL Data Protection Form
- UCL Insurance Registration Form
- Risk Assessment (CTIMPs & non-CTIMPs)
Standard Operating Procedure for JRO Administration of Research Passports (Last updated 11/12/2023)
UCL Complaints from Research Subjects About UCL Sponsored Studies and Trials policy
Protocol templates for UCL/UCLH sponsored research
- UCL/UCLH Observational protocol template
- UCL/UCLH Interventional studies protocol template
- UCL/UCLH Data only studies
Templates for supporting documents
The package of supporting documents you will need to provide will depend on the type of application and the type of research activity that is planned. Supporting documents include:
- Consent forms and participant information
- Contracts and study agreements
- Model Clinical Trial Agreement (mCTA) and CRO-mCTA
- Commercial Primary Care Model Clinical Trial Agreement (PC-mCTA)
- model Clinical Investigation Agreement (mCIA) and CRO-mCIA
- Model non-commercial agreement (mNCA)
- Model agreements for Participant Identification Centres (mC-PICA and mNC-PICA)
- Model Material Transfer Agreement
- Standalone Data Processing Agreements
- Other model agreements