Standard Operating Procedures (SOPs) and Guidance Documents

Operating Procedures

This section contains the Standard Operating Procedures (SOPs) and guidance documents issued by the R&I department. When a new SOP is authorised, or when an existing SOP is revised, Chief Investigators must ensure all staff within their team are trained on the relevant SOP and this training documented in a training record.

If you require assistance with SOP training please contact

The R&I office will endeavour to ensure all relevant staff are notified when a new or updated document has been approved for implementation. However, we encourage all investigators to visit this page regularly to ensure that they are aware of and working to the latest SOPs and guidance documents relevant to their research.


SOP Title


Next Review Due

RDSOP01 Preparation, Approval & Maintenance

RDSOP01 August 2021
RDSOP02 Research Governance Annual, Monthly & quarterly Monitoring RDSOP02 August 2021
RDSOP03 Delegation and Oversight of Investigator Responsibilities in Research Studies RDSOP03 January 2024

RDSOP04 Procedure for Identification of Potential Participants in Research Studies and Delegation of Clinician Responsibility to Research Delivery Team staff 


May 2024

RDSOP05 Maintaining a Study File and Version Control


October 2023

RDSOP06 Informed Consent


April 2024

RDSOP08B Pharmacovigilance for MHRA-regulated Clinical Trials not sponsored the Trust

RDSOP8B January 2024

RDSOP09 Notification of a Serious Breach of GCP or the Clinical Trial Protocol

RDSOP09 July 2021

RDSOP10 Investigation Medicinal Product (IMP) Management and Accountability

RDSOP10 August 2020

RDSOP11 Research Governance Monitoring

RDSOP11 October 2023

RDSOP12 Research Passport—Issue of Honorary Contracts and Letters of Access

RDSOP12 August 2023

RDSOP13 Contracts Management


August 2021

RDSOP14 Trust Sponsorship of Research

RDSOP14  July 2024

RDSOP15 Writing a GCP compliant Protocol for CTIMPS


August 2021

RDSOP16 Writing a GCP compliant protocol for non-CTIMPS


August 2021

RDSOP17 Research Data Management and Security

RDSOP17  August 2023

RDSOP18 Statistical Management Procedures


August 2021

RDSOP19 Financial Management of a Clinical Trial

RDSOP19 April 2024

RDSOP20 End of Study Notification


April 2024

RDSOP21 Retention of Data, Off-Site Archiving and destroying of Documents


April 2024

RDSOP22 Confirmation of Capacity and Capability procedure for CTIMPS


January 2024

RDSOP24 Sourcing Pharmacy Services from Pharmacy Providers

RDSOP24 July 2024

RDSOP25 Sourcing Investigational Medicinal Products (IMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPS)

RDSOP25 July 2024

RDSOP26 Using Non-Investigational Medicinal Products (NIMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPS)

RDSOP26 July 2024

RDSOP27 Implementing a Drug Recall for IMP NIMP

RDSOP27 July 2024

RDSOP28 Randomisation and Unbinding in CTIMPS


July 2024

RDSOP30 Study Conduct


August 2021

RDSOP31 Study Close-Out


April 2024

RDSOP32 Gaining MHRA Approval

RDSOP32 August 2021

RDSOP33 R&I Committee Safety Oversight

RDSOP33 August 2021

RDSOP34 Development Safety Update Reporting

RDSOP34 August 2021
RDSOP35 Principles of Paris use for consented GMMH study participants RDSOP35 January 2024
RDSOP36 Use of DATIX in Research RDSOP36 January 2024

RDSOP41 Recording and Reporting for Adverse Events for non– CTIMPS


August 2021