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

RDSOP04 Procedure for Identification of Potential Participants in Research Studies

RDSOP04

August 2019

RDSOP06 Informed Consent

RDSOP06

August 2019

RDSOP07A Informed Consent—Minors

RDSOP07A

August 2019

RDSOP07B Informed Consent—Incapacitated Adults (for CTIMPS)

RDSOP07B

August 2019

RDSOP13 Contracts Management

RDSOP13

August 2019

RDSOP15 Writing a GCP compliant Protocol for CTIMPS

RDSOP15

August 2019

RDSOP16 Writing a GCP compliant protocol for non-CTIMPS

RDSOP16

August 2019

RDSOP18 Statistical Management Procedures

RDSOP18

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

RDSOP28 Randomisation and Unbinding in CTIMPS

RDSOP28

August 2019

RDSOP30 Study Conduct

RDSOP30

August 2019

RDSOP31 Study Close-Out

RDSOP31

August 2019

RDSOP41 Recording and Reporting for Adverse Events for non– CTIMPS

RDSOP41

August 2019