Cambridge Clinical Trials Unit SOPs and Documents

The CCTU, part of Cambridge University Hospitals NHS Foundation Trust, makes its quality assurance (QA) documentation publicly available on its governance page. These materials underpin its work across phase II–IV drug trials, randomised controlled trials, single‑ and multi‑centre studies, and international research.

1. Pre‑Trial Phase
Covers the foundational planning activities to initiate a trial:

• Protocol development and documentation: Includes feasibility, site selection, and activation procedures (SOP081, SOP039).
• Funding and collaboration: Guidance on financial and partnership processes (INFO014, SOP054).
• CTIMP start‑up: Procedures for trial team setup and activation (SOP047).
• Complementary SOPs provide details on management structures, responsibilities, document control, participant information, and consent.

Example: Before activating a Clinical Trial of an Investigational Medicinal Product (CTIMP), a sponsor completes the site feasibility using SOP081, then moves to initiation per SOP039.

2. Pharmacovigilance

• Ensures participant safety through regulatory and operational safety oversight:
• Routine safety reporting: Annual DSUR and progress reports (SOP003).
• Urgent safety measures: Steps for immediate action in CTIMPs (SOP019).
• Investigator pharmacovigilance processes: Ongoing management of safety data and issues (SOP002).

3. Data Management and Statistics

• Handles all data‑related aspects from collection through analysis:
• Data collection and handling: Case report forms and management plans (SOP013, SOP033).
• Randomisation methods: Procedures for sealed envelopes and blinded approaches (SOP046, SOP058, SOP053).
• Statistical framework: Principles and analysis population definitions (SOP022, SOP023, SOP032).

4. Sample Management

• Defines laboratory and biosample handling processes:
• Laboratory selection and qualification: (GD054).
• Sample logistics: Management, equipment oversight, packaging, and transport (SOP044, SOP030, SOP016).
• Tracking and documentation: Template for monitoring sample processing (TPL031).

5. Trial Conduct

• Focuses on trial operations, monitoring, and compliance:
• Safety oversight and monitoring: Sponsor and on‑site review (SOP068, SOP007, SOP011, SOP061).
• Operational control: Version control, data transfer, deviation management, and form templates (SOP031, SOP029, SOP018, SOP014, FRM013, FRM121).

6. Close‑Out and Post‑Study

• Covers proper termination and archiving procedures:
• End‑of‑trial activities: Checklists and workflow documentation (FRM117A, SOP004).
• Archiving and retention: Location recording and secure long‑term storage (SOP006, FRM017, TPL037).
• Reporting: End‑of‑trial report templates for sponsor review.

How can it be useful for investigator‑initiated studies: 

• Provides a concrete operational framework for academic‑sponsored trials
• Individual SOPs that can be adapted by research teams or CTUs lacking their own documents and templates 
• llustrates best practice for UK‑regulated clinical research.
• Organisation: Documents can be browsed by lifecycle stage via on‑page category links and by document reference within each section.