1. INTRODUCTION This SOP has been produced in accordance with the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, the Department of Health s Research Governance Framework 2005 and ICH GCP Guidelines. This document describes the procedure for closing down a clinical trial sponsored by Nottingham University Hospitals (NUH) of an investigational medicinal product (CTIMP) and complies with the principles of good clinical practice (GCP). 2. SCOPE In accordance with The Medicines for Human Use (Clinical Trial) Regulations (2004) and the National Research Ethics Service (NRES), written notification of the end of trial shall be given for all clinical trials of Investigational Medicinal Products (CTIMPs) within 90 days of the end of project, or within 15 days if the project is terminated early. 3. PROCESS The definition of the end of the trial should be provided and justified in the protocol and any change to this definition should be notified as a substantial amendment. In most cases, it will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol. Final analysis of the data (following lock of the study database) and report writing may occur after formal declaration of the end of the project. For NUH sponsored trials please contact the appropriate Research Manager at Research and Development within three days of the end of trial. NUH, acting on behalf of the CI will notify the REC who gave favourable opinion and the MHRA. The information is to be sent when: the trial ends in the United Kingdom (UK) and/or the complete trial has ended in all participating centres, in all countries within and outside the EU. Once notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit. SOP 43 End of Trial Declaration for Studies Page 2
1. Information Required Complete the EudraCT Declaration of End of Study Form available at https://eudract.emea.europa.eu/document.html The following information should be provided: Name and address of the Sponsor or sponsoring group s legal representative in the UK Title of the trial EudraCT number Trial protocol code number, if any Date of end of trial Date of end of complete trial in all participating centres in all countries within and outside the EU, if relevant. Note: specific requirements may vary across countries The investigational medicinal product(s) (IMPs) tested in the trial. 2. Trial Suspended or Early Termination Whenever a trial is terminated early, the CI must notify the MHRA, REC and Sponsor within 15 days and clearly explain the reasons for termination. 3. Trial does not commence If the CI decides not to commence a trial, he or she should notify the MHRA, REC and Sponsor and clearly explain the reasons for not starting the trial. 4. Serious Adverse Events All SAEs must be followed up according to protocol, legal requirements and Sponsor SOP until resolved. 5. IMP (Investigational Medicinal Product) a. Return and destruction of IMPs must be carried out as according to protocol, legal requirements and Sponsor SOP. b. All IMP must be accounted for, including a check that all IMP has been returned by trial subjects and that all IMP not used for the study is present and unopened. c. IMPs are not to be destroyed until permission to do so is given by the Sponsor. A Destruction of IMP Certificate should be issued when the IMP is destroyed or sent for destruction. d. All IMP logs must be checked for accuracy and any discrepancies must be accounted for. Serious breaches in IMP accountability must be brought to the attention of the CI and Sponsor. 6. Clinical Samples SOP 43 End of Trial Declaration for Studies Page 3
Storage and destruction of clinical samples must be carried out as according to protocol, legal requirements and Sponsor. 7. Study Documentation a. A Quality Control check on the Trial Master File (TMF) and/or Investigator Site File must be made before archiving to ensure that all essential documents required are present. b. All Case Report Forms (CRFs) relating to study participants must be retained. c. Original, or copies of original, signed informed consent forms (ICFs) must be retained with the TMF. d. The study Participant Log must be retained in the TMF. e. The Pharmacy Site File (PSF) should be archived along with all other study files and documentation and should include randomisation codes, if any. 8. Data Management All data queries must be fully resolved before a study is archived. 9. Final Reports a. A summary of the final report on the research should be sent to the MHRA, main REC and Sponsor within 12 months of the end of the project. b. There is no standard format for final reports. As a minimum, the main REC and Sponsor should receive information on whether the project achieved its objectives, the main findings and arrangements for publication or dissemination of the research, including any feedback to participants. All correspondence with the MHRA and REC should be retained in the TMF and copied to the Sponsor. c. Checklist for Study Closure Close down : Inform MHRA and REC of Trial Close Down using The Declaration of the End of a Clinical Trial form Inform the Sponsor of Trial Close Down by copying the The Declaration of the End of a Clinical Trial form to them. Inform Host NHS R&D office of Trial Close Down by copying the The Declaration of the End of a Clinical Trial form to them. Study Reports: Within 12 months, provide MHRA and REC with End of Trial Study report. Data Analysis: After database lock Dissemination of Results Archiving SOP 43 End of Trial Declaration for Studies Page 4
d. References WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects. (http://www.wma.net/e/policy/b3.htm) Medicines for Human Use (Clinical Trials) Regulations 2004. (http://www.opsi.gov.uk/si/si2004/20041031.htm) It is assumed that by referencing the principal regulations, all subsequent amendments made to the principal regulations are included in this citation. CONSORT Transparent Reporting of Trials http://www.consort-statement.org/home/ SOP REVIEW PERIOD This procedure will be reviewed by the owner on a biennial basis, unless new local, national and/or international recommendations force an earlier review. SOP 43 End of Trial Declaration for Studies Page 5