Research and Development SOPs and Policies are listed below for your information.
- S01 – Preparation of SOPs V6
- S02 –Submitting Protocol Amendments V3
- S03 – Archiving V4
- S05 – Notification of Serious Breaches of GCP or Study Protocol V5
- S07 – Contracts V1.1
- S09 – CTIMP Sponsorship V2
- S11 – Delegation of Roles V3
- S13 – Regulatory Approvals V3
- S14 – Honorary Contracts V2
- S15 – Informed Consent V6
- S19 – Monitoring V6
- S21 – Confirmation of Capacity and Capability V3
- S22 – S22 Safety Reporting V5
- S26 – Training for Researchers V3
- S29 – Letters of Access and the Research Passport V4
- S31 – Reporting required for sponsored CTIMPs V3
- S39 – Venepuncture in Infants and Children V2
- S43 – Establishing and Maintaining Trial Master Files and Investigator Site Files for RD&E Sponsored Studies V3
- S45 – Transportation of Temperature Sensitive Medicinal Products for Clinical Trials V3
- S47 – Clinical trial participant pregnancy V2
- S48 – Non-CTIMP Sponsorship V2
- S52 – Urgent Safety Measures V3
- S60 – Electronic Transfer of Prescriptions to Trial Pharmacy V2
- S63 – Urgent Public Health Research V3
- S66 – Managing medical emergencies and incidents for research teams based outside the main hospital template V2
- Non-Cytotoxic Intrathecal IMP Policy V2