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 researchoffice@gmmh.nhs.uk

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

Link

Next Review Due

RDSOP01 Preparation, Approval & Maintenance

RDSOP01 October 2024
RDSOP02 Research Governance Annual, Monthly & quarterly Monitoring Decommissioned N/A
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 

RDSOP04

June 2026

RDSOP05 Maintaining a Study File and Version Control

RDSOP05

October 2023

RDSOP06 Informed Consent

RDSOP06

April 2024

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

RDSOP8B

August 2027

RDSOP09 Reporting Protocol and GCP Deviations, Violations and Serious Breaches in Research

RDSOP09 March 2027

RDSOP11 Research Governance Monitoring

RDSOP11 May 2026

RDSOP12 Facilitating Access for External Researchers: Research Passports, Honorary Contracts and Letters of Access

RDSOP12

August 2027

RDSOP13 Contracts Management

RDSOP13

October 2024

RDSOP14 Trust Sponsorship of Research

RDSOP14  July 2024

RDSOP16 Writing a GCP compliant protocol for non-CTIMPS

RDSOP16

January 2025

RDSOP17 Research Data Management and Security

RDSOP17  August 2023

RDSOP18 Statistical Management Procedures

RDSOP18

 October 2024

RDSOP19 Financial Management of a Clinical Trial

RDSOP19 April 2024

RDSOP20 End of Study Notification

Decommissioned

N/A

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

RDSOP21

April 2024

RDSOP22 Confirmation of Capacity and Capability procedure for CTIMPS

RDSOP22

May 2025

RDSOP24 Sourcing Pharmacy Services for Clinical Trials from non-GMMH Pharmacy Providers

RDSOP24

August 2027

RDSOP25 Sourcing Investigational Medicinal Products (IMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPS) not sponsored by the Trust

RDSOP25

August 2027

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 Unblinding in CTIMPS not sponsored by the Trust

RDSOP28

August 2027

RDSOP31 Study Close-Out

RDSOP31

August 2027

RDSOP35 Principles of Paris use for consented GMMH study participants   RDSOP35 May 2026

RDSOP41 Recording and Reporting Adverse Events for GMMH Sponsored Studies

RDSOP41

March 2027

RDSOP42 Grant Application Process

RDSOP42

August 2027

 

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