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 Postal Address: UCL, Gower Street London WC1E 6BT Tel No Fax No Web-sites: Standard Operating Procedure (SOP) for Preparation of Site File to Implement the National Institute for Health Research (NIHR) Research Support Services (RSS) Framework SOP ID Number Version Number Approved by Effective Date Review Date 1 Dr Sue Kerrison 16 th February th February 2014 Author: Name and Job Title Approved by Date: Target Trusts Hameedah Bogle-Dawoud Senior Research Administrator [SRA] 16 th February 2012 UCLH and RFH Target Audience Investigator RSS SOP2 Related SOPs Investigator RSS SOP3 Close the study down SOP4 Study approvals and NHS permission SOP8 Setup and Control Study Processes SOP e-document kept: G: RESEARCH: RM&G Team/NIHR RMG RSS SOPs/ SOP-13_Preparation of Site File and S: RMG\NIHR RSS SOPs 1 of 16

2 Revision Chronology Previous SOP ID Number Effective Date Reasons for Change Author 2 of 16

3 Joint Research Office 1. SUMMARY This SOP describes the essential documentation that should be maintained within a Site File. Non CTIMPs sponsored by UCL, UCLH or RF Hampstead should follow either Appendix 2 or 3 depending on type of study. Information about the requirements for UCL sponsored CTIMPs can be found at: For hosted studies, the sponsor should provide guidance but where they do not, the following guidance should be used. a. CTIMPS where the sponsor does not provide an SOP for this purpose - Appendix 1 b. Interventional studies Appendix 2 c. Studies not in category a or b above Simple Studies - Appendix 3 2. DEFINITIONS Clinical Trial of Investigational Medicinal Product (CTIMP) Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal products(s) and/or Study absorption, distribution, metabolism and excretion of one or more investigational product(s) with the object of ascertaining its (their) safety and/or efficacy. NIHR RSS Framework (including Appendix 1 Glossary of Terms and Acronyms) Interventional study A study where the research intervention is one of the following A device A drug but not a CTIMP A Procedure which requires entry into a body cavity Radiation including X-rays Surgery 3. PURPOSE and SCOPE This SOP outlines the requirements for keeping site files for UCL sponsored studies with the exception of CTIMPs Hosted studies where the sponsor does not provide guidance 3 of 16

4 If after reading the guide anything is unclear or you would like to discuss study documentation in greater detail, please contact a member of the JRO R&D RM&G Team. 4. RELATED SOPs Investigator RSS SOP3 Close the study down SOP4 Study approvals and NHS permission SOP8 Setup and Control Study Processes 5. JOINT RESEARCH OFFICE (JRO) POLICY All SOPs produced from the JRO must be used in conjunction with local NHS Trust and UCL policies and procedures. Where applicable there is also a requirement to include stakeholder engagement as appropriately identified. The JRO represents UCL, UCLH or RF as the Sponsor and UCLH and RF as Participating Sites, depending on the type of research study. The JRO is responsible to ensure that appropriate research management and governance processes are in place. The RM&G SOPs will provide a quality assurance system for these requirements. 6. BACKGROUND This SOP complies with RG framework Research Governance Framework for Health and Social Care 2005 (2 nd Edition), NIHR RSS framework Good Clinical Practice (GCP) European Directives for CTIMPs as 2001/20/EC and 2005/20/EC (these Directives were transposed into UK law as statutory instruments SI2004/1031, SI2006/1928) and subsequent amendments incorporating elements of ICH GCP tripartite guidelines (E6). Data Protection Act 1998 It is a legal requirement to maintain a Site File or Trial Master File (TMF) for all CTIMPs. For other studies, it is a requirement of the Research Governance Framework. Sponsors of Clinical Trials, falling under the Medicines for Human Use (Clinical Trials) Regulations (CTIMPS), usually provide SOPs indicating their requirements for keeping an Investigator Site File or TMF. Where such SOPs are provided by the sponsor, for CTIMPs and non CTIMPS, then the investigators must follow them. However, where no such instructions are provided then investigators should follow guidance for different types of studies to be found in Appendices of 16

5 Documentation for each study should be kept in a study file with a dedicated member of staff responsible for maintaining and updating the file. The filing of study documents, in an orderly and timely manner, greatly assists the smooth running of the study and aids any audits, monitoring visits or inspections. 7. RESPONSIBLE PERSONNEL AND THEIR DUTIES Responsible person e.g. RNC Summary of duties 1 Chief or Principal investigators ensuring that a site file is kept in accordance with the guidance in Appendices Designated Research Team ensuring that a site file is kept in accordance with the guidance in Appendices PROCEDURE Essential Documents and Site File (TMF) Initiation and Maintenance 1. A Site File or TMF should be established as soon as possible after an outline protocol/proposal is available and/or first contact is made with a research Sponsor. 2. The Chief or Principal Investigator should designate a specific member of the research team to be responsible for maintaining and updating the essential documents within the Site File or TMF until the study is formally closed. 3. Not all documents listed in the Appendices 1-3 will be of relevance to every project the content of the Site File or TMF will therefore differ according to the nature of the study. For example, for Clinical Trials of Investigational Medicinal Products (CTIMPs), most of the essential documents must legally be maintained, whereas, for solely observational studies the storage of some documents will not be applicable. This SOP has attempted to indicate this wherever possible. The guide should, therefore, be read in the context of each specific project. The Appendices are not exhaustive and it is strongly recommended that any approvals and communication not listed here should also be retained. 4. For multi centre studies, the Site File or TMF should be held at the site acting as the lead in the investigation. Minimal and locally relevant documents should be kept at participating, or hosting, sites. 5. For amended documents, amendment chronologies must kept, indicating the changes and the dates in which these were implemented. Old documents must be retained in the Site File or TMF alongside the new amended version(s). Please remember that any substantial amendments to documents such as the protocol or informed consent forms should be approved by the relevant authorities (the research Sponsor, RECs, MHRA etc.), as appropriate, prior to implementing any changes to the study/trial at each participating site. 5 of 16

6 Storage 1. As some of the documents within a TMF will be originals and/or contain confidential data, it is important that they are retained within a secure place and with restricted access. It is recognised as best practice to store documents within a locked cupboard within a locked room, never off site. 2. Documents should be maintained in a legible condition and easy to retrieve. There are currently no regulations relating to the storage of documents in electronic format, until such a time, it is necessary to print and retain the hard copies of all study information. 3. For CTIMPs, only, source documents must be traceable. Source documents are the original documents relating to the trial, to medical treatment and the history of the subject, e.g.; the patients medical record, laboratory reports, subject diaries, x-ray films, etc. If documents are routinely stored separately from the patient notes and they belong to the source data, then a note should be made in the Study File or in the other source data as to where the other documents are stored. If there are several such documents, it maybe necessary to complete a table for each documenting where they can be found (Location of Source Data form). Archiving 1. It may be necessary for the results of a clinical research project/trial to be examined and checked after it has finished so essential documents should be archived in an easily accessible way and readily available on request. For further details on archiving see G: RESEARCH: RM&G Team/NIHR RMG RSS SOPs/ SOP12/Archiving Study 9. IMPLEMENTATION & TRAINING If after reading the guide anything is unclear or you would like to discuss study documentation in greater detail, please contact a member of the JRO R&D RM&G Team. The fully approved and signed master copy is also stored in a designated binder within the JRO. Any further changes to the SOP after this point will have to be undertaken through the Document Control System. 10. REVIEW SOPs will be reviewed every 2 years unless an earlier review is required. 6 of 16

7 11. ACRONYMS CI CTIMP GCP ICH ISF JRO MHRA NIHR RSS (RSS) PI QA REC RM&G RFH SI SOP TMF UCL UCLH Chief Investigator Clinical Trial of Investigational Medicinal Products Good Clinical Practice International Conference on Harmonisation Investigator Site File Joint UCL/UCLH/Royal Free Research Office Medicines and Healthcare products Regulatory Agency National Institute for Health Research (NIHR) Research Support Services Principal Investigator Quality Assurance Research Ethics Committee Research Management & Governance Royal Free Hospital NHS Trust Statutory Instrument Standard Operating Procedure Trial Master File University College London University College London Hospitals NHS Foundation Trust 12. REFERENCES JRO Website Research Governance Framework 2005 (2 nd Edition) lasset/dh_ pdf NIHR RSS Framework (including Appendix 1 Glossary of Terms and Acronyms) 7 of 16

8 13. APPENDICES Appendix 1 CTIMPs Study Site File [where Sponsor provides no guidance] TABLE OF CONTENTS Site File Index Study synopsis Sponsor Contact details Sheet 1.0 CORRESPONDENCE 1.1 s/Letters/Telephone Conversation /Investigator Meeting 1.2 Related Sponsorship / Regulatory correspondence 2.0 SPONSORSHIP / R&D APPROVAL 2.1 Sponsorship letter 2.2 Insurance/Indemnity Letter 2.3 Data Protection Form and registration confirmation 2.4 Signed Site-Specific Form (SSIF) / IRAS Form / R&D Form 2.5 Honorary contracts / Research Passport / Letter of access for non- NHS staff 2.6 R&D NHS Permission Letter (CI & Sponsor to hold approvals for each site if multi-site) 2.7 Site Initiation Visit Register 2.8 Participating Site NHS Permission Letter 3.0 AGREEMENTS 3.1 Grant Application and award letter(s) 3.2 Full Economic Costing for the study 3.3 Funding Approval Letter / Arrangements / Funder s grant conditions or Reference to conditions 3.4 Pharmacy Agreement (if applicable) 3.5 Clinical Trials Agreement (if applicable) 3.6 Material Transfer Agreement (if applicable) 3.7 Funding Agreement(s) 3.8 Laboratory Service Agreement (if applicable) 3.9 PI / CI Agreement 3.10 Clinical Study Site Agreement (CTSA) for participating sites 3.11 other Agreements (if applicable) 4.0 REGULATORY APPROVALS 4.1 REC Provisional Opinion Letter (if applicable) 4.2 REC Approval Letter 4.3 Medicines Healthcare products Regulatory Agency (MHRA) OR confirmation that study is not a clinical trial under the Medicines for Human use (Clinical Trial) Regulations 4.4 MHRA Notice of Acceptance Letter 4.5 Human Tissue Authority confirmation that an HTA licence is not required 4.6 Human Fertilisation and Embryology Authority (HEFA) (Human embryology and fertility studies) 4.7 ARSAC / IRMER certificate / approval letter 4.7 Gene Therapy Advisory Committee (GTAC) (Genetically modified substances) Filed? (Y/N) N/A 8 of 16

9 4.8 Substantial Amendment Acknowledgement and Approval Letter(s) 4.9 Substantial Amendment Notification form(s), supporting superseded versions of all ethics approved documents and Cover letter(s) submitted to MHRA and REC 4.10 NRES Progress / Annual Safety Report(s) / Final Report 5.0 PROTOCOL 5.1 Final Approved Protocol 5.2 All Superseded versions of the protocol (if applicable) 5.3 Log of (Protocol or GCP) Deviations / Violations / Potential Serious Breaches / Serious Breaches / Urgent Safety Measures 5.4 Protocol Training Log 5.5 Summary of all Logs of amendment 6.0 PARTICIPANT INFORMATION 6.1 Patient / Subject Information Sheet (PIS) / (SIS) 6.2 Previously Approved PIS(s) / SIS(s) 6.3 Informed Consent Form (ICF) 6.4 Previously Approved ICF(s) 6.5 Log of all different versions of the PIS and consent form 6.6 GP Letter 6.7 Previously Approved GP Letter(s) 6.8 Patient Screening Log 6.9 Patient Enrolment Log 6.10 Original Informed Consent Forms for all patients consented at site 7.0 RESEARCH TEAM 7.1 Name / Log of all personnel involved in the study 7.2 Signed and Dated CVs for site personnel OUTLINING GCP and other Trainings 7.3 GCP course certificate of each staff member working on this study. If a central Lab is being used to carry out a specific test, then the GCP certificate of the Head of that Lab is required to be in the Chief Investigator s file 7.4 Staff Signature Log and Site Delegation of Tasks 7.5 Individual Staff SOPs and Courses Training Log 8.0 SERIOUS ADVERSE EVENT 8.1 Serious Adverse Event Log All Adverse Events should be recorded in the Serious Adverse Event Log for PHASE 1 studies. 8.2 Sample SAE form and a copy of SOP for the recording, Management and Reporting of AEs by the investigator 8.3 Completed SAE and SUSAR Forms hour contact card (if applicable) 8.5 SOP for the Recording and Reporting of (protocol and GCP) deviations, violations, serious breaches and urgent safety measures. 8.6 Emergency Un-blinding (If applicable) SOP 8.7 Copies of correspondence to report SAE / SUSARs to Sponsor (e.g. acknowledgment of receipt of SUSAR by the JBRU) 9.0 MONITORING AND AUDIT 9.1 Log of Monitoring Reports 9.2 Reviews of CI/PIs self-monitoring reports 9.3 MHRA Study specific findings list 9.4 CI s review of PI-self monitoring reports 9 of 16

10 9.5 CI s self-monitoring reports or PI s self-monitoring reports 9.6 Audit Summary / report and certificate 10.0 STANDARD OPERATING PROCEDURES 10.1 Relevant local and sponsor s / hosts SOP and applicable policies 11.0 TREATMENT RELATED DOCUMENTS 11.1 Product Information Update 11.2 Last version of (IMPD, SmPC, IB) MUST be updated yearly 11.3 Decoding SOP for Blinded Study s 11.4 IMP Accountability Form (completed BEFORE ARCHIVING) 11.5 Destruction Log completed (if applicable) 11.6 Last version of (IMPD, SmPC, IB) MUST be updated yearly 12.0 DATA MANAGEMNET (COLLECTION, HANDLING & STORAGE) 12.1 Signal detection, trend analysis undertaken by the PI and CI 12.2 Signed, dated and completed CRFs (or a File Note with location) 12.3 Sample copy of template (case report file CRF) approved by Sponsor 12.4 Superseded versions of template (case report file CRF) 12.5 Instructions for completion (if applicable) 12.6 Completed data collection tool(s) if stored in a different site contact for access should be noted Previous versions of data collection tool(s) 13.0 LABORATORY RELATED DOCUMENTS IF APPLICABLE 13.1 List of Study specific Labs used with contact details 13.2 Record of retained body fluids/tissue/samples 13.3 List of Study specific equipment used 13.4 Copies for calibration records for technical equipment 13.5 Lab technical procedure/test certification of accreditation 13.6 Normal Lab reference ranges for any tests or medical procedures in the protocol 13.7 Record of retained body fluids/tissue/samples 14.0 STUDY CLOSURE AND ARCHIVING 14.1 End of Study Notification 14.2 End of Site Notification 14.3 Appointed Archiving Personnel Details 14.4 Archiving arrangements and logs 14.5 Summary of study findings 15.0 MISCELLANEOUS 10 of 16

11 Appendix 2 Interventional Study Site File TABLE OF CONTENTS Site File Index Study synopsis Sponsor Contact details Sheet 1.0 CORRESPONDENCE 1.1 s/Letters/Telephone Conversation /Investigator Meeting 1.2 Related Sponsorship / Regulatory correspondence 2.0 SPONSORSHIP / R&D APPROVAL 2.1 Sponsorship letter 2.2 Insurance/Indemnity Letter 2.3 Data Protection Form and registration confirmation 2.4 Signed Site-Specific Form (SSIF) / IRAS Form / R&D Form 2.5 Honorary contracts / Research Passport / Letter of access for non- NHS staff 2.6 R&D NHS Permission Letter (CI & Sponsor to hold approvals for each site if multi-site) 2.7 Site Initiation Visit Register (if applicable) 2.8 Participating Site NHS Permission Letter (s) 3.0 AGREEMENTS 3.1 Grant Application and award letter(s) (if applicable) 3.2 Full Economic Costing for the study(if applicable) 3.3 Funding Approval Letter / Arrangements / Funder s grant conditions or Reference to conditions(if applicable) 3.4 Pharmacy Agreement (if applicable) 3.5 Material Transfer Agreement (if applicable) 3.6 Funding Agreement(s) (if applicable) 3.7 Laboratory Service Agreement (if applicable) 3.8 PI / CI Agreement 3.9 Clinical Study Site Agreement (CTSA) for participating sites(if applicable) 3.10 Agreement for supply of equipment (if applicable) 3.11 other Agreements (if applicable) 4.0 REGULATORY APPROVALS 4.1 REC Provisional Opinion Letter (if applicable) 4.2 REC Approval Letter 4.3 For Device studies, Medicines Healthcare products Regulatory Agency (MHRA) letter or confirmation that study is not a device trial under the Medicines for Human use (Clinical Trial) Regulations. The Device Brochure/CE marking certificate 44 For Mechanistic studies, Medicines Healthcare products Regulatory Agency (MHRA) letter or confirmation that study is not a Mechanistic trial under the Medicines for Human use (Clinical Trial) Regulations 4.5 For studies of non EC marked devices, MHRA Notice of Acceptance Letter 4.6 Human Fertilisation and Embryology Authority (HEFA) (Human embryology and fertility studies) (if applicable) 4.7 ARSAC / IRMER certificate / approval letter (if applicable) 4.8 Substantial Amendment Acknowledgement and Approval Letter(s) 4.9 Substantial Amendment Notification form(s), supporting superseded versions of all ethics approved documents and cover letter(s) Filed? (Y/N) N/A 11 of 16

12 submitted to REC (and MHRA if applicable) 4.10 NRES Progress / Annual Safety Report(s) (if applicable)/ Final Report 5.0 PROTOCOL 5.1 Final Approved Protocol 5.2 All Superseded versions of the protocol (if applicable) 5.3 Protocol violations 5.4 Protocol Training Log 5.5 Summary of all Logs of protocol amendment 6.0 PARTICIPANT INFORMATION 6.1 Patient / Subject Information Sheet (PIS) / (SIS) 6.2 Previously Approved PIS(s) / SIS(s) 6.3 Informed Consent Form (ICF) 6.4 Previously Approved ICF(s) 6.5 Log of all different versions of the PIS and consent form 6.6 GP Letter (if applicable) 6.7 Previously Approved GP Letter(s) 6.8 Patient Screening Log 6.9 Patient Enrolment Log 6.10 Original Informed Consent Forms for all patients consented at site 7.0 RESEARCH TEAM 7.1 Name / Log of all personnel involved in the study 7.2 Signed and Dated CVs for site personnel outlining other Training 7.3 GCP course certificate of each staff member working on this study 7.4 Staff Signature Log 7.5 Delegation Log 7.6 Protocol Training Programmes 8.0 REPORTABLE EVENTS 8.1 Serious Adverse Event Log 8.2 Incident reports 8.3 Complaints Log 8.4 Copies of correspondence regarding reportable events 8.5 Protocol breaches and actions 9.0 AUDIT 9.1 Audit Reports 10.0 STANDARD OPERATING PROCEDURES 10.1 Relevant local and sponsor s / hosts SOP and applicable policies 11.0 RELATED DOCUMENTS 11.1 Product Information Update(if applicable) 11.2 Device related documents (if applicable) 12.0 DATA MANAGEMENT (COLLECTION, HANDLING & STORAGE) 12.1 Signed, dated and completed CRFs (or a File Note with location) 12.2 Completed data collection tool(s) if stored in a different site contact for access should be noted Previous versions of data collection tool(s) 13.0 LABORATORY RELATED DOCUMENTS IF APPLICABLE 13.1 List of Study specific Labs used with contact details(if applicable) 13.2 Record of retained body fluids/tissue/samples(if applicable) 12 of 16

13 13.3 List of Study specific equipment used(if applicable) 13.4 Copies for calibration records for technical equipment(if applicable) 13.5 Lab technical procedure/test certification of accreditation(if applicable) 13.6 Normal Lab reference ranges for any tests or medical procedures in the protocol(if applicable) 14.0 STUDY CLOSURE AND ARCHIVING 14.1 End of Study Notification 14.2 End of Site Notification 14.3 Appointed Archiving Personnel Details 14.4 Archiving arrangements and logs 14.5 Summary of study findings 15.0 MISCELLANEOUS 13 of 16

14 Appendix 3 Simple Study Site File TABLE OF CONTENTS Site File Index Study Synopsis Sponsor Contact details Sheet Filed? (Y/N) N/A 1.0 CORRESPONDENCE 1.1 s / Letters / Telephone Conversation / Investigator Meeting 1.2 Related Sponsorship / Regulatory correspondence 2.0 SPONSORSHIP / R&D APPROVAL 2.1 Sponsorship Letter 2.2 Insurance / Indemnity Letter 2.3 Data Protection Form and Registration Confirmation (UCL Sponsor) 2.4 Signed Site-Specific Form (SSIF) / IRAS Form / R&D Form if applicable 2.5 Honorary Contracts / Research Passport / Letter of Access for non- NHS staff 2.6 R&D NHS Permission Letter (CI and Sponsor to hold approvals for each site if multi-site) if applicable 2.7 Participating Site NHS Permission Letter (s) if applicable 3.0 AGREEMENTS / FUNDING 3.1 Grant application and award letter(s) if applicable 3.2 Full Economic Costing for the study if applicable 3.3 Funding Approval Letter / Arrangements / Funder s conditions or reference to condition if applicable 3.4 Material Transfer Agreement (if applicable 3.5 Funding Agreement(s) 3.6 Laboratory Service Agreement (if applicable) 3.7 PI / CI Agreement 3.8 Clinical Study Site Agreement (CTSA) for participating sites 3.9 Other Agreements (if applicable) 4.0 REGULATORY APPROVALS 4.1 REC Provisional Opinion Letter (if applicable) 4.2 REC Approval Letter 4.3 Substantial Amendment Acknowledgement and Approval Letter(s) 4.4 Substantial Amendment Notification form(s), supporting superseded versions of all ethics approved documents and cover letter(s) submitted to MHRA and REC 4.5 NRES Progress / Annual Safety Report(s) / Final Report 14 of 16

15 TABLE OF CONTENTS 5.0 PROTOCOL 5.1 Final Approved Protocol 5.2 All Superseded versions of the protocol (if applicable) 5.3 Log of Protocol Deviations 5.4 Urgent Safety Measures 6.0 PARTICIPANT INFORMATION (IF APPLICABLE) 6.1 Patient / Subject Information Sheet (PIS) / (SIS) if applicable 6.2 Previously Approved PIS(s) / SIS(s) 6.3 Informed Consent Form (ICF) 6.4 Previously Approved ICF(s) 6.5 Log of all different versions of the PIS and ICF(s) 6.6 GP Letter if applicable 6.7 Previously Approved GP Letter(s) Filed? (Y/N) N/A 7.0 RESEARCH TEAM 7.1 Name / Log of all personnel involved in the study 7.2 Signed and dated CVs for site personnel ( outlining GCP and other Training) 8.0 INCIDENTS, COMPLIANTS and PROTOCOL BREACHES 8.1 Incident reports 8.2 Incident report forms if applicable 8.3 Complaints 8.4 Protocol breaches and actions 8.5 Copies of correspondence to relating incidents, complaints and protocol violations 9.0 AUDIT 9.1 Audit reports 10.0 STUDY CLOSURE AND ARCHIVING 10.1 End of Study Notification 10.2 End of Site Notification 10.3 Appointed Archiving Personnel Details 10.4 Archiving arrangements and logs 10.5 Summary of Study Findings 11.0 MISCELLANEOUS 15 of 16

16 14. SIGNATURE PAGE Author: Name / Job Title Hameedah Bogle-Dawoud Senior Research Administrator [SRA] Signature / Date: 16 th February 2012 Reviewed by: Name / Job Title Dr Susan Kerrison Head of Risk and Regulation Signature / Date: 16 th February 2012 Authorised by: Name / Job Title Dr Susan Kerrison Head of Risk and Regulation Dr Rajinder Sidhu RM&G Manager Signature / Date: 16 th February th February of 16

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