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R&I 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 research@mhsc.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.
If you wish to have your name added to the email alert system for SOP updates then please contact research@mhsc.nhs.uk
| SOP Title | Reference number | Version | Last review | Next review |
|---|---|---|---|---|
| Preparation, approval and maintenance of Trust Research (R&D) Standard Operating Procedures | rdsop1 | 2 | January 2016 | |
| Researcher Database | rdsop2 | 2 | November 2016 | July 2018 |
| Definition and delegation of investigator responsibilities for CTIMPs | rdsop3 | 2 | November 2016 | July 2018 |
| Research Approval Process (including amendments) | rdsop4 | 3 | November 2016 | April 2018 |
| Maintaining a study file and version control | rdsop5 | 2 | November 2016 | July 2018 |
| Informed consent | rdsop6 | 2 | November 2016 | July 2018 |
| Informed consent -incapacitated adults | rdsop7 | 2 | November 2016 | July 2018 |
| Pharmacovigilance for Trust-Sponsored MHRA-regulated Clinical Trials | rdsop8a | 2 | December 2013 | |
| Pharmacovigilance for MHRA-regulated Clinical Trials not sponsored by the Trust | rdsop8b | 2 | December 2013 | |
| Serious breaches of GCP or the clinical trial protocol | rdsop9 | 2 | December 2013 | |
| IMP approval process | RDSOP10a | 1.1 | Superseded by: Manchester Mental Health and Social Care Trust's (MMHSCT) Approval Procedure for Clinical Trials of Investigational Medicinal Products (CTIMPs) - see RDSOP22 below | |
| IMP Management and accountability | rdsop10b | 3 | February 2016 | February 2019 |
| Research Governance Monitoring | rdsop11 | 2 | January 2015 | |
| Research Passport-Honorary Contracts/Letters of Access | rd sop12 | 2 | November 2016 | July 2018 |
| Contracts Management | rdsop13 | 2 | January 2015 | |
| Trust Sponsorship of Research | rdsop14 | 2 | January 2015 | |
| Writing a GCP compliant protocol for CTIMPs | rdsop15 | 2 | January 2015 | |
| Preparing a GCP compliant protocol for non-CTIMPs | rdsop16 | 2.1 | November 2016 | July 2018 |
| Research Data Management and Security | rdsop17 | 2.1 | November 2016 | July 2018 |
| Statistical Management Procedures | rdsop18 | 2.1 | November 2016 | July 2018 |
| Financial Management of a Clinical Trial | rdsop19 | 2 | January 2015 | |
| End of Study Notification | rdsop20 | 2 | January 2015 | |
| Retention of data, off site archiving and destroying documents | rdsop21 | 2 | January 2015 | |
| Approval Procedure for Clinical Trials of Investigational Medicinal Products (CTIMPs) | rdsop22 | 1.0 | December 2013 | |
| Sourcing Pharmacy Services from Pharmacy Providers | rdsop24 | 3.0 | February 2016 | February 2019 |
| Sourcing Investigational Medicinal Products (IMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPs) | rdsop25 | 2.1 | February 2016 | February 2019 |
| Using Non-Investigational Medicinal Products (NIMPs) in Clinical Trials of an Investigational Medicinal Product (CTIMPs) | rdsop26 | 2.1 | February 2016 | February 2019 |
| Implementing a Drug Recall for IMP/NIMP | rdsop27 | 3.0 | February 2016 | February 2019 |
| Randomisation and Unblinding | rdsop28 | 2.1 | February 2016 | February 2019 |
| Version Control | rdsop29 | 1.0 | March 2018 | |
| Study Conduct | rdsop30 | 1.0 | March 2018 | |
| Study Close-Out | rdsop31 | 1.0 | March 2018 | |
| Gaining MHRA Approval | rdsop32 | 1.0 | November 2016 | March 2018 |
| R&I Committee Oversight | rdsop33 | 1.0 | November 2016 | March 2018 |
| Development Safety Update Reporting | rdsop34 | 1.0 | November 2016 | March 2018 |
| Recording and reporting AEs for non CTIMPs | rdsop41 | 1.0 | November 2016 | March 2018 |
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