Here you can find supporting documents and templates for both the LinCTU and the Clinical Governance SOPs. You are welcome to download these documents, but please acknowledge the source, and tell us if you see any changes that are required.
- CG-QMS RF CG01-RF02 Internal/External Training Log
- CG-QMS RF CG08-RF02 Site Initiation Checklist
- CG-QMS RF CG08-RF03 Site Initiation Outstanding Issues Report
- CG-QMS RF CG09-RF01 Screening and Enrolment Log
- CG-QMS RF CG10-RF01 Serious Adverse Event (SAE) Report
- CG-QMS RF CG12-RF01 Amendment Log
- CG-QMS RF CG13-RF01 Audit Report
- CG-QMS RF CG13-RF02 CAPA Plan
- CG-QMS RF CG13-RF03 CAPA Log
- CG-QMS RF CGD3-RF01 Data and Document Storage Record
Additional Clinical Governance templates:
- Consent From (NHS Research)
- CV Template for IRAS Applications
- Delegation and Signature Log
- Organisation Information Document for non-commercial projects
- Organisation Information Document for data processing only (Non-commercial projects)
- Participant Information Sheet (NHS Research)
- Protocol (Non-interventional e.g. interviews / focus groups / questionnaires)
- Protocol (Interventional e.g. taking blood / active participation)
- Protocol (CTIMP / Device Study)
Please contact us if there is a document you need but can not find.