Standard Operating Procedures for Sponsorship
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Sponsor's Representative: Caroline Garrett (researchsponsorship@sussex.ac.uk)
Email. researchsponsorship@sussex.ac.uk
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Sponsored studies (Non-CTIMPs) SOPs
| SOP Title |
|---|
Clinical Trials of an Investigational Medicinal Product (CTIMPs)
This CTIMP Management Framework sets out the minimum expectations for management and oversight of University sponsored CTIMPs. Compliance with these requirements ensures adherence to the applicable legislation and guidance and ensures the University meets its legal obligations as Sponsor of CTIMPs. The Framework is intended to sit alongside the suites of SOPs for Clinical Trial Units (CTUs) managing studies.
Please contact the Sponsor's Representative (researchsponsorship@sussex.ac.uk) with any queries.
| SOP Reference Number | SOP Title |
|---|---|
| SOPRGO01a | |
| SOPRG04 |
Appendix 1: Risk assessment template |
| SOPRG05a |
Monitoring CTIMP research Studies Appendix 1: On site monitoring template Appendix 2: Central monitoring template |
|
SOPRG09a |
|
|
SOPRG10 |
CTIMP Delegation of roles and responsibilities Appendix 1: Delgation log template |
|
SOPRG16 |
Amendments, Urgent Safety Measures and Temporary Halt to a Trial |
|
SOPRG21 |
Appendix 1: Serious Adverse Event Report E-SUSAR reporting portal: https://esusar.mhra.gov.uk/ CTIMPs safety reporting to REC form: https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/safety-reporting/ |
|
SOPRG33 |
Archiving Paper Trial Documents (for University of Sussex as a Sponsor) Appendix 1: Pre-archiving checklist |
|
SOPRG35 |
|
|
SOPRG36 |
Research Passports
General information about the NHS Research Passport system is available from the HRA website.
- Staff: Consult the University NHS Research Passport guidance note on the procedure to follow.
- Students: Contact the Research Governance Officer for more specific University procedures for students.
- BSMS students: Contact the BSMS Research Administrator.