Index of Standard Operating Procedures for all research Sponsored by the UHL

Transcription

1 University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the October Please note that with effect from 2015, all SOPs and Appendices use the same Version Number. Previous versions must not be used after 1 st Originals must be obtained from the Research Web Pages to ensure that the latest versions are being used. Appendix SOP Ref Title Version PCG Ref. No S 1001 Standard Operating Procedure for writing Standard Operating Procedures for Research & Development procedures conducted within or sponsored by University Hospitals of Leicester NHS Trust () (SOP for SOPs) OBSOLETE: Sponsor category confirmation for research sponsored by University Hospitals of Leicester NHS Trust () Date 7 C6/2012 February Review Date June 3.0 C7/2012 March 2015 March S 1002 S 1003 Documentation review process for research sponsored by University Hospitals of Leicester NHS Trust () Sponsor risk assessment and management of research sponsored by University Hospitals of Leicester NHS Trust () 5 C8/2012 March December 6 C9/2012 March December Appendix 1 Sponsor Request Form V5 Appendix 2 Peer Review Form V5 Appendix 3 Data & CRF Information Form V3 Obsolete Dec 2016 Appendix 1 Risk Matrix V6 Appendix 2 Risk Assessment Form V6 Appendix 3 Risk Summary Table V4 OBSOLETE Dec 16 Appendix 4 Risk Assessment Flow Chart V6 Appendix 5 Sponsor review checklist for studies not requiring Risk Assessment V6 Page 1 of 8 Last updated 11 th October

2 S 1004 S 1005 Development Safety Update Report for Clinical Trials of Investigational Medicinal Product Studies Sponsored by University Hospitals of Leicester NHS Trust () Management of contracts for research sponsored by University Hospitals of Leicester NHS Trust () 7 C20/2013 February 5 C4/2014 February Appendix 6 Sponsor review checklist for studies that do require Risk Assessment V6 Appendix 7 Sponsor review document V6 Appendix 1 - Development Safety Update Report Template. V7 Appendix 2 DSUR Reporting Timeframe Guidance Document V7 Appendix 3 DSUR Timeframe flowchart V7 Appendix 1 Contract & Review process V5 S 1006 S-1007 Informed Consent for Research Sponsored by University Hospitals of Leicester NHS Trust () Management (Monitoring) for research sponsored by the University Hospitals of Leicester NHS Trust () 8 C11/2014 March 8 C16/2013 March Appendix 1 Delegation of Authority & Signature Log V8 Appendix 2 Assent Signature Log V8 Appendix 3 Assent/Consent Log V8 Appendix 4 Witness Consent Form Template V8 Appendix 5 Consent Witness Statement V8 Appendix 6 Pre-Consent Proforma Template V8 Appendix 1 Monitoring Plan V8 Appendix 2 Risk Based Monitoring Strategy V8 Appendix 3 Contact Monitoring Log V8 Appendix 4 - Monitoring Visit Log V8 Page 2 of 8 Last updated 11 th October

3 S-1008 S-1009 S-1010 S-1011 Training for Staff Engaged in Research Sponsored by University Hospitals of Leicester NHS Trust () Processing and Reporting of Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions for all Research Sponsored by University Hospitals of Leicester NHS Trust () Chief Investigator Responsibilities for Research Sponsored by University Hospitals of Leicester NHS Trust () Site Initiation for Clinical Trials of Investigational Medicinal Products Research Sponsored by University Hospitals of Leicester NHS Trust () 7 C12/2014 March 8 C10/2014 February 9 C22/2013 February 9 C17/ 2013 February Appendix 5 Schedule of Source Data V8 Appendix 6 - Monitoring Visit Report Form V8 Appendix 7 Pharmacy Visit report Form V8 Appendix 8 Non-CTIMP Monitoring Visit report V8 Appendix 1 SOP Read Log V7 Appendix 2 Protocol Training Log V7 FORM A CTIMP Reporting Form V8 FORM B NON-CTIMP Reporting Form V8 Appendix 1 Pregnancy Form V8 Appendix 2 Multi-centre site listings table V8 Appendix 3 AR/AE/SAE Log V8 Appendix 4 - Flow Chart V8 Appendix 5 SAE amendment request V8 Appendix 6 Multi-Centre line listing template for CTIMPs V8 Appendix 1 Roles & Responsibilities of CI document V9 Appendix 1 Site Initiation Check List V9 Appendix 2 Pharmacy Check List V9 Appendix 3 - SOP Read Log V9 Appendix 4 Subject Screening Log V9 Appendix 5 Subject Enrolment Log V9 Page 3 of 8 Last updated 11 th October

4 S-1012 S-1013 S-1014 Management and Production of Corrective And Preventative Action plan (CAPA) for Studies Sponsored by University Hospitals of Leicester () Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Clinical trials Sponsored by the University Hospitals of Leicester NHS Trust () Green Light Process for Research Sponsored by University Hospitals of Leicester NHS Trust () 6 C13/2014 February 6 C16/2014 February 9 C17/2014 February December Appendix 6 Site Initiation Checklist Non-CTIMP V9 Appendix 7 Site Initiation Checklist Non-CTIMP Guidance V9 Appendix 1 CAPA Form V6 Appendix 2 CAPA Tracking Log V6 Appendix 1 Serious Breach notification form V6 Appendix 2 File note template V6 Appendix 3 Protocol Deviation Log V6 Appendix 1 Green Light Process First Site V9 Appendix 2 Green Light Process Multi Site V9 Appendix 3 Green Light Process Agreements V9 S-1015 S-1016 Management of Essential Documents and Trial Filing for Research Sponsored by University Hospitals of Leicester NHS Trust () Procedure in the Event of Non-Compliance in Research Sponsored by University Hospitals of Leicester NHS Trust () 7 C18/2014 February 5 C19/2014 February Appendix 1 TMF / ISF Contents CTIMP V7 Appendix 2 TMF / ISF Contents Non-CTIMP V7 Appendix 3 Version Control Doc. V7 S-1017 Green Light Process for Amendments to research Sponsored by University Hospitals of Leicester NHS Trust () 5 C35/2013 February July Appendix 1 Amendments requiring MHRA only V5 Appendix 2 Amendments requiring MHRA & REC authorisation V5 Page 4 of 8 Last updated 11 th October

5 S-1018 Approval of Amendments or Additions to Documents for Studies Sponsored by University Hospitals of Leicester NHS Trust () 4 C20/2014 February Appendix 3 Amendments requiring REC opinion V5 Appendix 4 Amendments not requiring notification V5 Appendix 5 Multi-Centre Sponsor Amendment Green Light Process V5 Appendix 6 First / Single Site Sponsor Amendment Green Light Process V5 S-1019 S-1020 S-1021 S-1022 Procedure for the Management of Fraud and Misconduct in Research Sponsored by University Hospitals of Leicester NHS Trust () Process for Assessing Site Feasibility for Research Sponsored by University Hospitals of Leicester NHS Trust () Process for Writing Study Protocols for Research Sponsored by University Hospitals of Leicester NHS Trust () Process for Submission of Annual Progress Reports for Research Sponsored by University Hospitals of Leicester NHS Trust () 4 C24/2015 February 4 C32/2014 February 5 C33/2014 February 4 C34/2014 February July Appendix 1 Suspected Fraud or Misconduct Initial Investigation Template V4 Appendix 2 Suspected Fraud and Misconduct Interview Template V4 Appendix 3 Evidence Listing Template V4 Appendix 1 Site Feasibility Assessment (SFA) V4 Appendix 2 Pharmacy Site Feasibility Assessment V4 Appendix 1 CTIMP Protocol Template V3 OBSOLETE w/e Jan Appendix 2 Non-CTIMP Protocol Template V4 - OBSOLETE w/e Jan Appendix 3 Protocol Training Log V5 Page 5 of 8 Last updated 11 th October

6 S-1023 Process for the IB / SPC Preparation, Review, Approval and Amendment for Research Sponsored by University Hospitals of Leicester NHS Trust () 4 C35/2014 February Appendix 1 IB Template V4 Appendix 2 IB Review Template V4 S-1024 S-1025 S-1026 S-1027 S-1028 S-1029 Process for Study Close Down for Research Sponsored by University Hospitals of Leicester NHS Trust () SOP for Convening a Data Safety Monitoring Committee for Research Sponsored by University Hospitals of Leicester NHS Trust () Urgent Safety Measures SOP for Research Sponsored by University Hospitals of Leicester NHS Trust () Creating a Statistical Analysis Plan for Research Sponsored by University Hospitals of Leicester NHS Trust () Amendments to Contracts for Research Sponsored by University Hospitals of Leicester NHS Trust () Archiving of Essential documents for Research Sponsored by University Hospitals of Leicester NHS Trust () 4 C27/2014 February 4 C28/2014 February 5 C29/2014 February 4 C30/2014 February 4 C31/2014 February 5 C37/2014 March December Appendix 1 Site Closedown Report V4 Appendix 2 Site Closedown visit log V4 Appendix 3 Site Closedown Checklist Non CTIMP V4 Appendix 1 DSMC Charter Template V4 Appendix 1 Urgent Safety measures Template V5 Appendix 1 Archiving Assessment Check List V5 Appendix 2 Archiving Electronic Aspects of TMF V5 Appendix 3 Pre-Archiving Check List V5 Appendix 4 Archiving Process flowchart V5 Appendix 5 Retrieval process flowchart V5 Appendix 6 Archiving Timeline Guidance V5 FORM A V5 FORM B V5 Page 6 of 8 Last updated 11 th October

7 S-1030 S-1031 S-1032 End of Study and study reporting for Research Sponsored by University Hospitals of Leicester NHS Trust () Data Management process for Research Sponsored by University Hospitals of Leicester NHS Trust () Process for Identifying and engaging the services of an external Vendor to provide services for research sponsored by University Hospitals of Leicester NHS Trust () 4 C38/2014 February July 4 C39/2014 February 2 C2/ March January 2019 FORM C V5 S-1033 S-1034 S-1035 S-1036 S-1037 S-1038 Randomisation and Blinding for Research Studies sponsored by the University Hospitals of Leicester NHS Trust () Finance approval process for Research sponsored by University Hospitals of Leicester NHS Trust () Case Report Form production for research sponsored by the University Hospitals of Leicester NHS Trust () Quality Assurance (Audit) of Research Sponsored by the University Hospitals of Leicester NHS Trust () Healthy Volunteers for Research sponsored by University Hospitals of Leicester NHS Trust () Processing and Reporting SAEs, SADEs and USADEs for Medical Device Studies 4 C40/2014 February 3 C48/2015 February 5 C41/2014 February July 2 C6/ March 4 C1/2015 February December 1 C71/ October October 2019 Appendix 1 Case Report Form Template V5 Appendix 2 Guide to completing CRF V5 Appendix 1 Template TOPs Consent Form V4 Appendix 1- Event Categorization Flow Chart V1 Appendix 2 Adverse Event/Device Effect record V1 Appendix 3 Serious Adverse Event Report Form C Appendix 4 -Multicentre line listing V1 Appendix 5 MHRA reporting Timelines Table V1 Page 7 of 8 Last updated 11 th October

8 Appendix 6Medical Device Process Flowchart V1 Appendix 7 Template SAE SADE Follow Up Information Request V1 S-1039 SOP S-1039 Sample management for research studies sponsored by 1 C72/ October October 2019 Appendix 1a Fridge Temperature Log V1 Appendix 1b Freezer Temperature Log V1 Appendix 1c Nitrogen Vessel Storage Log V1 Appendix 2 Sample Tracking Log V1 Appendix 3 Sample End of Study Notification Form V1 Appendix 4 Shipping Instructions for Biological Samples V1 Appendix 5 Human Tissue Disposal Form V1 Page 8 of 8 Last updated 11 th October