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 2019
RDSOP02 Research Governance Annual, Monthly & quarterly Monitoring RDSOP02 August 2019
RDSOP03 Definition & Delegation of Investigator Responsibilities for CTIMPs RDSOP03 July 2020

RDSOP04 Procedure for Identification of Potential Participants in Research Studies

RDSOP04

August 2019

RDSOP05 Maintaining a Study File and Version Control

RDSOP05 July 2020

RDSOP06 Informed Consent

RDSOP06

August 2019

RDSOP07A Informed Consent—Minors

RDSOP07A

August 2019

RDSOP07B Informed Consent—Incapacitated Adults (for CTIMPS)

RDSOP07B

August 2019

RDSOP08A Pharmacovigilance for Trust-Sponsored MHRS-regulated Clinical Trials

RDSOP8A September 2020

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

RDSOP8B September 2020

RDSOP09 Notification of a Serious Breach of GCP or the Clinical Trial Protocol

RDSOP09 July 2019

RDSOP10 Investigation Medicinal Product (IMP) Management and Accountability

RDSOP10 August 2020

RDSOP11 Research Governance Monitoring

RDSOP11 August 2020

RDSOP12 Research Passport—Issue of Honorary Contracts and Letters of Access

RDSOP12  July 2020

RDSOP13 Contracts Management

RDSOP13

August 2019

RDSOP14 Trust Sponsorship of Research

RDSOP14 August 2020

RDSOP15 Writing a GCP compliant Protocol for CTIMPS

RDSOP15

August 2019

RDSOP16 Writing a GCP compliant protocol for non-CTIMPS

RDSOP16

August 2019

RDSOP17 Research Data Management and Security

RDSOP17 July 2020

RDSOP18 Statistical Management Procedures

RDSOP18

August 2019

RDSOP19 Financial Management of a Clinical Trial

RDSOP19 August 2019

RDSOP20 End of Study Notification

RDSOP20

August 2019

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

RDSOP21

August 2019

RDSOP22 Confirmation of Capacity and Capability procedure for CTIMPS

RDSOP22

August 2019

RDSOP24 Sourcing Pharmacy Services from Pharmacy Providers

RDSOP24 August 2019

RDSOP25 Sourcing Investigational Medicinal Products (IMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPS)

RDSOP25 August 2019

RDSOP26 Using Non-Investigational Medicinal Products (NIMPs) for Clinical Trials of an Investigational Medicinal Product (CTIMPS)

RDSOP26 August 2019

RDSOP27 Implementing a Drug Recall for IMP NIMP

RDSOP27 August 2019

RDSOP28 Randomisation and Unbinding in CTIMPS

RDSOP28

August 2019

RDSOP30 Study Conduct

RDSOP30

August 2019

RDSOP31 Study Close-Out

RDSOP31

August 2019

RDSOP32 Gaining MHRS Approval

RDSOP32 August 2019

RDSOP33 R&I Committee Safety Oversight

RDSOP33 August 2019

RDSOP34 Development Safety Update Reporting

RDSOP34 August 2019

RDSOP41 Recording and Reporting for Adverse Events for non– CTIMPS

RDSOP41

August 2019