STANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down

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1 Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 17. Study Close Down According to ICH Good Clinical Practice (GCP) the close-down of a clinical trial can only be done when both investigator/institution and sponsor files have been reviewed and it has been confirmed that all necessary documentation pertaining to the trial have been completed. ICH GCP guidelines define the study documents to be filed after completion or termination of the trial, see Appendix 1. This is an essential part of the trial process. 2. PURPOSE This Standard Operating Procedures (SOP) is to describe the procedure for study close-down for Basildon and Thurrock University Hospitals NHS Foundation Trust (BTUH) hosted and non-clinical trials of an investigational medicinal product (non-ctimp) BTUH sponsored studies and details the process and essential documentation required. 3. APPLICABLE TO This SOP is applicable to all investigative site personnel who are members of the study teams. If BTUH sponsored, the Chief Investigator (CI) is responsible for informing all members of the study team(s) and all applicable review bodies of the study closure. The CI or delegate is responsible for the closure of the trial according to regulatory and sponsor requirements. The CI should ensure for BTUH sponsored trials that the end of trial is detailed in the approved protocol. If a multi-centre study, the CI should ensure that all sites comply with the study closed procedures. If BTUH hosted, the Principal Investigator (PI) or delegate is responsible for the closure of the trial at BTUH according to regulatory and sponsor requirements. The definition of the end of study should be agreed before the study start and documented clearly in both the protocol and any corresponding agreements. If the end of trial is amended during the course of the trial this should be submitted as a substantial amendment. Study closure responsibilities should be clearly documented in the trial delegation log. 4. PROCEDURE 4.1 Trust Sponsored non-ctimp Study Close Down As soon as the CI is ready to close down the study the CI, or delegate, should develop a closed down process (if not already documented in the protocol); if a multi-centre study the CI to circulate this process to all PIs at all participating sites. Consideration needs to be made to Appendix 1 when developing the closed down process. The CI must inform the research ethics committee (REC) of the close down of the study and will have 12 months to provide the REC with the final study report (refer to the Health Research Authority (HRA) website for up-to-date documents). Once the End of Trial acknowledgements have been received from the REC and Research and Development (R&D) have expressed no material

2 issues with the study closed down, the study can be considered closed and can be archived following SOP 18 Archiving and Destroying Documents. Other CI considerations / actions; If the study is registered on a public research database (e.g. ClinicalTrials.gov) to update as appropriate Make arrangements for future use of research data and samples Fulfil commitments to study participants, such as providing information about the outcome(s) of the research and care after research Publications; researchers have an ethical obligation to publish their research and if the Journal is going to issue a Press Release the Author must inform the Communications Department (Media Policy) 4.2 Trust Hosted Study Close Down As soon as the PI or any study personnel are informed of study closure, the research team will ensure that all data required by the protocol are recorded and that all essential documents are filed (see list of essential documents Appendix 1). The study team will meet to finalise the closure of the study and to confirm that all study-related activities have stopped. The PI or delegate to ensure that all data queries have been completed and any equipment loaned / provided by the sponsor have been returned. The study team need to notify the R&D Office who will update the study status and; Ensure any Honorary Contract or Letters of Access are terminated Ensure any Monitor access is removed from Electronic Medical Records (EMR) Remove Patient Alerts from EMR Ensure all finance is up-to-date The essential documents will be retained in accordance with SOP 18 Archiving and Destroying Documents. A member of the research team will inform pharmacy and other support departments of the study closure. It is the responsibility of each service support department to ensure they close-down in accordance to the study s procedure and forward any files/documents to R&D for archiving. The research team should send a copy of the formal notification of study closure received from the sponsor to the R&D office. Once R&D has received the Sponsor s notification of study closure and the Trial Status Notification form, they will close the study on the R&D database. 5. SUPPORTING DOCUMENTS SOP 12 Monitoring Visits SOP18 Archiving and Destroying Documents Media Policy (CO/PO/00144) 6. REFERENCES ICH-GCP, Section 8.4 Health Research Authority Page 2 of 6

3 7. APPENDICES Appendix 1: Close-down study file contents list 8. DOCUMENT HISTORY Revision Date Previous Revision Date Summary of Changes July Clarification on roles Changes Marked Page 3 of 6

4 APPENDI 1: Close-down study file contents list This guide describes the essential documentation that is required under ICH Good Clinical Practice (ICH GCP). The Clinical Trials Regulations do not require the adoption of ICH GCP but the checklist provides a useful reference. This section will be updated in line with changing regulatory requirements. ICH GCP Ref. Topic Before the clinical conduct of the trial Located in Investigator file Investigator s Brochure Signed protocol and amendments, if any, and sample case report form Information given to trial subject Advertisement for subject recruitment Financial aspects of the trial Insurance statement (where required) Signed agreement between involved parties Dated, documented approval of Research Ethics Committee Research Ethics committee composition Regulatory Authority Authorisation (if applicable) Curriculum vitae and Other documents evidencing qualifications of investigator(s) and sub-investigator(s) Normal values/ranges for medical/lab tests included in the protocol Medical/lab/technical procedures/tests Certification or accreditation; established quality control; Other validation Sample of label(s) attached to medicinal products Instructions for handling of investigational products and trial-related materials (if not in protocol or Investigator Brochure) Shipping records for investigational numbers products Certificates of analysis of investigational product shipped Decoding procedures for blinded trials Master Randomisation List Pre-trial monitoring report Located in file of sponsor Page 4 of 6

5 During the clinical conduct of the trial In addition to having on file the above documents, the following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. ICH GCP Ref. Topic Located in Investigator file Located in file of sponsor Investigator s Brochure updates Any revision to: Protocol/amendment(s) and CRF Informed consent form Patient/Parent Information Sheets Dated, documented approval of independent ethical committee of the following: Protocol amendment(s) Revisions of: Informed consent form- Patient/Parent Information Sheets Any Other documents where approval required Regulatory authorities approvals where required Curriculum vitae for new investigator(s) and subinvestigator(s) Updates to normal values/ranges Updates of medical/lab/technical procedures/tests Documentation of investigational product Certificates of analysis for new batches of investigational product Monitoring visit reports Relevant communication other than site visits Letters inc. printed s, Meeting reports, Notes of telephone calls Signed informed consent forms Source documents Signed, dated and completed case report forms (copy) (original) Documentation of CRF corrections (copy) (original) Notification by originating investigator to sponsor of serious adverse events and related reports Notification by sponsor and/or investigator, where applicable, to regulatory authorities of unexpected serious adverse drug reactions and of other safety information (where required) Notification by sponsor to investigators of safety information Interim or annual reports to independent ethics committees (where required) Subject screening log (where required) Subject identification code list Subject enrolment log Investigational products accountability at site Signature sheet Record of retained body fluids/tissue samples (if any) Page 5 of 6

6 After completion or termination of trial After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the following: ICH GCP Topic Located in Located in file Ref. Investigator file of sponsor Investigational product(s) accountability at site Documentation of investigational product (if destroyed destruction at site) Completed subject identification code list Audit certificate (if available) Final trial close-out monitoring report Treatment allocation and decoding documentation Final report by investigator to Independent ethics committee where required Clinical study report (if applicable) Page 6 of 6