Standard Operating Procedures (SOPs) and Guidance Documents Accessibility Tools Selecteer een taal MENU Home Research and Innovation Researcher Resources Standard Operating Procedures (SOPs) and Guidance Documents 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 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 RDSOP04 May 2024 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 January 2024 RDSOP09 Notification of a Serious Breach of GCP or the Clinical Trial Protocol RDSOP09 July 2021 RDSOP11 Research Governance Monitoring RDSOP11 October 2023 RDSOP12 Research Passport—Issue of Honorary Contracts and Letters of Access RDSOP12 August 2023 RDSOP13 Contracts Management RDSOP13 October 2024 RDSOP14 Trust Sponsorship of Research RDSOP14 July 2024 RDSOP16 Writing a GCP compliant protocol for non-CTIMPS RDSOP16 August 2021 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 RDSOP20 April 2024 RDSOP21 Retention of Data, Off-Site Archiving and destroying of Documents RDSOP21 April 2024 RDSOP22 Confirmation of Capacity and Capability procedure for CTIMPS RDSOP22 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 RDSOP28 July 2024 RDSOP30 Study Conduct RDSOP30 August 2021 RDSOP31 Study Close-Out RDSOP31 April 2024 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 RDSOP41 October 2024 Taking Part in Research Research Units Researcher Resources Carrying Out Research Communications Resources and Guidance Recording Recruitment in GMMH Standard Operating Procedures (SOPs) and Guidance Documents Useful links and online training R&I News Events Performance in Initiating and Delivering Research Contact Us R&I Our CQC Rating Service users and carers Visiting GMMH Carers, Family and Friends Helpful information Get involved Professionals Work for us Research and Innovation Get involved Training Crisis Care Suicide prevention Referral services Greater Manchester Mental Health NHS Foundation Trust Bury New Road, Prestwich, Manchester, M25 3BL Tel: 0161 773 9121 Greater Manchester Mental Health NHS FT © 2021 Powered by VerseOne Technologies Ltd We place cookies on your computer to help make this website better. You can at any time read our privacy policy to find out more. By using this site we will assume that you are happy to continue.