Joint Research Office

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1 Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Tel: Fax: Website: Postal Address: UCL, Gower Street London WC1E 6BT Standard Operating Procedure for Assess, Arrange and Confirm (Feasibility) Assessments conducted for UCLH Hosted Studies by the Joint Research Office (JRO) SOP ID Number Version Number Effective Date Review Date JRO SOP Author: Name and Job Title Reviewed by Target Audience Tabitha Kavoi, Senior Portfolio Coordinator (JRO) 1. Arpita Shivmani, Contracts and Legal Affairs (JRO) 2. Jamil Ahmed, Portfolio Coordinator (JRO) 3. Joe Mwanza, Head of Finance (JRO) 4. Sanjeev Kumar, Finance Manager (JRO) 5. Stuart Braverman, Data and Information Manager (JRO) Joint Research Office UCLH Service Support Departments Please check this is the latest version of the SOP on the Joint Research Office website:

2 Revision Chronology Version Effective Date Reasons for Change Author FIRST VERSION

3 Standard Operating Procedure for Assess, Arrange and Confirm (Feasibility) Assessments for UCLH Hosted Studies Managed by the Joint Research Office 1. Purpose and Scope This Standard Operating Procedure (SOP) describes the procedure for conducting Assess, Arrange and Confirm (feasibility) assessments for UCLH hosted research studies managed by the Joint Research Office (JRO). The scope of this SOP covers: The procedure for registration of studies managed by the JRO The procedure for feasibility assessments, contracting, costing and service support department authorisations for studies managed by the JRO The requirements for maintaining study trackers, ReDA updates throughout the assessment process The required level of information sharing between the JRO and the study investigator and Sponsor This SOP outlines how the JRO will manage and track studies for which it is assigned the feasibility lead. The procedures outlined in this SOP are in line with the UCLH wide requirements for Assess, Arrange and Confirm (feasibility) as outlined in: JRO SOP 17 Standard Operating Procedure for Feasibility Assessments for UCLH Hosted Studies Managed by UCLH Research Units and Clinical Research Facilities. This SOP should be read in conjunction with: SOP 17: Standard Operating Procedure for Assess, Arrange and Confirm (feasibility) assessments conducted for UCLH hosted studies managed by UCLH Research Units and Clinical Research Facilities SOP 19: Standard Operating Procedure for costing activities associated with Assess, Arrange and Confirm (AAC) for studies conducted at UCLH SOP 20: Standard Operating Procedure for Assess, Arrange and Confirm (feasibility) assessments conducted for UCLH hosted studies by UCLH Service Support Departments JRO Guidance (feasibility) 1: Guidance on contracting process for UCLH Hosted studies JRO Guidance (feasibility) 2: Requirements for Assess, Arrange and Confirm (feasibility) assessments: Pharmacy JRO Guidance (feasibility) 3: Requirements for Assess, Arrange and Confirm (feasibility) assessments: Imaging and Nuclear Medicine JRO Guidance (feasibility) 4: Requirements for Assess, Arrange and Confirm (feasibility) assessments: Clinical Director Authorisations JRO Guidance (feasibility) 5: JRO reda and templates to support Assess, Arrange and Confirm (feasibility) assessments JRO Guidance (feasibility) 6: JRO Feasibility Form: Guidance for completion

4 Exemptions to the procedure: This SOP does not cover the review procedures for studies sponsored by UCLH nor UCL. The SOP covers only activity considered to be host site feasibility assessments. This SOP does not cover the responsibility of the units in the oversight or tracking of studies once commenced at UCLH. This procedures outlined in this SOP are applicable to studies where the HRA have provided, or are in the process of providing a HRA assessment. In circumstances where the HRA have specifically advised that confirmation of capacity and capability are not required, the JRO will liaise with the Sponsor to determine the cost and contracting requirement for the study. The JRO and the Sponsor will then determine (and document) which further steps will be applicable. In such circumstances the JRO will outline which aspects of this SOP were applicable to the approval of the study. This will be documented within the JRO Quality Management Systems and within the JRO database, ReDA. 2. Responsibilities The JRO as a feasibility Unit is responsible for conducting Assess, Arrange and Confirm (feasibility) assessments on behalf of UCLH investigators and Divisions which do not have arrangements to manage these reviews locally. The JRO will maintain a list of Units which do have adequate local arrangements in place. These Units are formally delegated to take on these responsibilities from the JRO. This list and associated delegations are maintained within the JRO SOP store (ReDA). The responsibilities of each unit (including the JRO) when conducting Assess, Arrange and Confirm (feasibility) are outlined in an associated SOP: JRO SOP 17 Standard Operating Procedure for Feasibility Assessments for UCLH Hosted Studies Managed by UCLH Research Units and Clinical Research Facilities. Responsible Personnel Covered within this SOP: JRO Feasibility Coordinator JRO Research Officer JRO Contracts Manager JRO Finance Officers JRO Service Support Administrator 3. Outline Procedure for the receipt and management of host studies at UCLH The procedure (depicted in flow diagram 1. below) outlines the core roles and responsibilities of each group within the JRO when conducting the Assess, Arrange and Confirm (feasibility) review. The procedure notes the updating of a tracker ( tracker updated ) and ReDA. This tracker is the JRO study progress tracker. ReDA is the JRO study database. Details of the tracker and ReDA, their use and oversight are held separate to this document. The procedure notes three sets of core documentation required the first code document set, the service support department agreed documents and information and the final document set. The content of each are outlined within the relevant guidance notes as outlined in section 1.

5 JRO Data Management: Flow diagram 1: JRO procedure for Assess, Arrange and Confirm (feasibility) where JRO acts as a feasibility unit. Sponsor approach to JRO site set up Within 24 working hours register study and requests minimum document set as defined in SOP 17 page 8, uploads to ReDA and populates all ReDA fields according to ReDA guidance. Within 24 working hours of receipt of minimum document set as defined in SOP 17 page 8, allocate to JRO coordinator and notify SP (update ReDA) Makes contact with the SP/PI within 24 working hours of allocation (ReDA updated and added to the tracker) PI s/nurses: Within 5 working days, confirms the following: SOA and SOE or costing template reflects correct time to deliver procedure (sense check) Completes relevant section of feasibility assessment form. Confirms study feasibility (in principle). JRO Research Officer and PI: Liaises with Network to secure funding/ resources (tracker updated) Confirms funding/ resources with JRO Coordinator Within 24 working hours alert JRO contract & Legal affairs regarding contracts (according to HRA initial assessment- ensure templates are in ReDA) (ReDA & tracker updated) Within 2 working days, determine Service Support requirements by reviewing minimum document set and provide SDA with agreed documents/information via ReDA (ReDA & tracker updated) Within 2 working days completes relevant sections of the feasibility assessment form using the document set provided (ReDA & tracker updated) Within 2 working days, contacts PI with part feasibility form, costing template/ SOA & SOE and other relevant documents from the minimum document set as per SOP 17 page 8 (ReDA & tracker updated) Updates ReDA & tracker the receipt of study feasibility confirmation from the PI. Alerts JRO Research Officer & JRO Costing Team of any additional NIHR costs/ resource required from LCRN (ReDA & tracker updated) Collates & alerts JRO Costing Team of sense- checked costing template/soa/ SOE and completion of UCLH costs etc. (ReDA & tracker updated) Attaches feasibility form, draft costing template/soe & SOA and seeks Clinical Directors Authorisation (ReDA & tracker updated) Request response from Clinical Directors within 5 working days. Collates all final documents and outstanding regulatory approvals Completes feasibility checklist ReDA & tracker updated and populates all ReDA fields according to ReDA guidance JRO Contract Manager: Within 24 working hours respond and advise on deviation from contract templates to JRO Coordinator as per SOP 17 section 4 (F) Initiate contract review/negotiation with the SP within 3 working days of receipt from the JRO Coordinator. Request a response from the SP within 5 working days (ReDA updated) SDA: Confirms agreement to the contract to JRO Coordinator & JRO costing team. Passes agreed relevant documents to the Service Support Departments within one working day of receipt (ReDA & tracker updated) Service Department: SDA: Completes costing and feasibility review within 10 working days and sends back confirmation to SDA. JRO Costing team: Within one working day of receipt of confirmation, forwards feasibility & costings to JRO coordinator and costings to JRO Costings team (ReDA & tracker updated) Verify tariffs on costing template/soe from the JRO Coordinator within 3 working days of receipt. If off the template costs are identified, liaise with relevant departments & request response within 5 working days. Advise JRO Coordinator & PI where additional costs may be required & liaise with the sponsor once PI has confirmed. Request response from SP within 5 working days & inform JRO Coordinator. Once costs agreed, insert financial appendix to the contract. Alerts JRO Coordinator & confirm with JRO Contracts Manager that contracts can be signed (ReDA updated) JRO contract & Legal: Within one working day obtains contract signatures Within 7.5 working hours, alerts JRO Data Management to issue decision to deliver - Updates Reda and tracker JRO Data Management: Within 7.5 working hours of JRO Coordinator alert, provide decision to deliver to PI, SP and LCRN where applicable Updates Reda SP: Sponsor PI: Principle Investigator SDA: Service Department Administrator LCRN: Local Clinical Research Network, SOA: Statement of Activities, SOE: Schedule of Events

6 Appendix 1: Feasibility Checklist Document Description On ReDA? (Y/N) Version and/or date. 1. IRAS Form Fully signed and dated by the CI and Sponsor (and any other signatories) 2. Copy of HRA Initial All correspondence related to HRA Assessment letter (if one is issued) and (when issued) HRA Approval letter 4. Protocol Latest REC and HRA approved version 5. REC approval All the correspondence related to REC, this includes provisional approvals, response to further clarification and any amendments made since the original approval and related correspondence 6. Participant Information Sheet Latest REC and HRA approved version localised (with contact details) and on local site headed paper 7. Consent Forms Latest REC and HRA approved version localised (with contact details) and on local site headed paper 8. GP Information sheet/letter (If applicable) Latest REC and HRA approved version localised and on local site headed paper 9. Advertisement & Invitation Letter (If applicable) Latest REC and HRA approved version localised and on local site headed paper e.g. Participant invitation letters, posters, newspaper, website adverts, diary care, questionnaires etc. 10. MHRA approval Applicable to CTIMPs and regulated device trials only. 11. ARSAC Certificate Applicable where exposure to radioactive material is involved that is in addition to routine care 12. Investigator s Brochure Applicable for Device Trials and CTIMPs only 13. SmPC Applicable to CTIMPs/trials involving drugs only 14. Evidence of valid Insurance Fully signed and dated

7 15. Contract(s) Signed 16. Statement of Activities Applicable to non-commercial studies 17. Schedule of Events Applicable to non-commercial studies 18. CV for Principal Investigator Most up to date version. DO NOT include personal details on the CV e.g. home address, date of birth 19. CVs of all members of the local research team 20. GCP Certificates for all members of the local team 21. Other Regulatory approvals 22. Research Passports For those listed on SSI form. Most up to date. DO NOT include personal home addresses and details on the CVs Applicable to CTIMPs only. Ensure this is no more than 2 years old Any other e.g. CAG, GTAG, etc. and all correspondence Applicable where members of the local research team are not directly employed by the local research site 23. Costing review completed 24. Pharmacy authorisation 25. Radiology authorisation Feasibility form 26. Clinical Director authorisation/ committee approval 27. Confirmation of Capacity and Capability to deliver study Where there is no contract with a financial appendix, confirmation from JRO costings should be sought Applicable to CTIMPs only. uploaded Applicable to studies involving radiation only. and/or form uploaded Completed and authorised by the Clinical Director uploaded with signed contract or statement of activities where applicable

8 SIGNATURE PAGE Author: Name / Job Title Tabitha Kavoi, Senior Portfolio Coordinator Signature / Reviewed by: Name / Job Title 1. Arpita Shivmani, Contracts and Legal Affairs (JRO) 2. Jamil Ahmed, Portfolio Coordinator (JRO) 3. Joe Mwanza, Head of Finance (JRO) 4. Sanjeev Kumar, Finance Manager (JRO) 5. Stuart Braverman, Data and Information Manager (JRO) Signature 1. / Signature 2. / Signature 3. / Signature 4. / Signature 5. / Authorised by: Name / Job Title Rajinder Sidhu Deputy Director, Research Support Signature /