Standard Operating Procedures (SOPs) and Guidance Documents
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 |
April 2024 |
|
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RDSOP08B Pharmacovigilance for MHRA-regulated Clinical Trials not sponsored the Trust |
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 |
August 2027 | |
|
RDSOP13 Contracts Management |
October 2024 |
|
|
RDSOP14 Trust Sponsorship of Research |
RDSOP14 | July 2024 |
|
RDSOP16 Writing a GCP compliant protocol for non-CTIMPS |
January 2025 |
|
|
RDSOP17 Research Data Management and Security |
RDSOP17 | August 2023 |
|
RDSOP18 Statistical Management Procedures |
October 2024 |
|
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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 |
April 2024 |
|
|
RDSOP22 Confirmation of Capacity and Capability procedure for CTIMPS |
May 2025 |
|
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RDSOP24 Sourcing Pharmacy Services for Clinical Trials from non-GMMH Pharmacy Providers |
August 2027 | |
|
RDSOP25 Sourcing Investigational Medicinal Products (IMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPS) not sponsored by the Trust |
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 |
August 2027 |
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RDSOP31 Study Close-Out |
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 |
March 2027 |
|
|
RDSOP42 Grant Application Process |
August 2027 |
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