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.
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SOP Title |
Link |
Next Review Due |
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RDSOP04 Procedure for Identification of Potential Participants in Research Studies |
August 2019 |
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RDSOP06 Informed Consent |
August 2019 |
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RDSOP07A Informed Consent—Minors |
August 2019 |
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RDSOP07B Informed Consent—Incapacitated Adults (for CTIMPS) |
August 2019 |
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RDSOP13 Contracts Management |
August 2019 |
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RDSOP15 Writing a GCP compliant Protocol for CTIMPS |
August 2019 |
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RDSOP16 Writing a GCP compliant protocol for non-CTIMPS |
August 2019 |
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RDSOP18 Statistical Management Procedures |
August 2019 |
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RDSOP20 End of Study Notification |
August 2019 |
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RDSOP21 Retention of Data, Off-Site Archiving and destroying of Documents |
August 2019 |
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RDSOP22 Confirmation of Capacity and Capability procedure for CTIMPS |
August 2019 |
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RDSOP28 Randomisation and Unbinding in CTIMPS |
August 2019 |
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RDSOP30 Study Conduct |
August 2019 |
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RDSOP31 Study Close-Out |
August 2019 |
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RDSOP41 Recording and Reporting for Adverse Events for non– CTIMPS |
August 2019 |