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 | 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 |
RDSOP05 |
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 |