STANDARD OPERATING PROCEDURE

Transcription

1 STANDARD OPERATING PROCEDURE Title Reference Number End of Study Report SOP-RES-027 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s) Natalie McGregor, Research Project Manager Teresa O Leary, Head of Regulatory Compliance Authorisation (Original signatures are retained by Research & Innovation) Dr Stephen Ryder Director of Research & Innovation Dr Stephen Fowlie Medical Director 04 Apr Apr 2016 USERS OF THIS STANDARD OPERATING PROCEDURE MUST REFER TO TO ENSURE THE MOST CURRENT VERSION IS BEING USED

2 Page 2 of 6 1. Document History Version Issue Date Reason for Change Number 1 7 th May 2014 Original SOP Apr 2016 Biennial review

3 Page 3 of 6 2. Introduction The results of a study must be documented in a final report which should accurately reflect the study objectives, what happened and the outcome of the results. All final study reports must be submitted to the appropriate bodies within 12 months of the end of the study. For clinical research with medicinal products which falls under Directive 2001/20/EC, the final study report and clinical trial summary results must be posted in the European Clinical Trials Database (EudraCT). The definition of the end of the study can be found in the protocol. The timelines for paediatric studies are 6 months after the end of the study but this could be extended to 12 months if the submitting party has demonstrated submission is not possible within 6 months for objective scientific reasons. 3. Purpose and Scope This standard operating procedure (SOP) is intended to assist with the writing of the end of study report for studies sponsored by Nottingham University Hospitals NHS Trust (NUH). This SOP should be used when compiling the final study report for submission to the Medicines and Healthcare products Regulatory Agency (MHRA), EudraCT, Research Ethics Committee (REC) and sponsor. For studies not sponsored by NUH, individual sponsor reporting requirements will apply. 4. Responsibilities Chief Investigator (CI) Complies the end of study report and submits it to the sponsor within 10 months of the end of study. Responsible for updating the Clinicaltrials.gov record or EudraCT with the results of the study. If the appropriate permissions enabling the CI to do this have not been set up, the CI should contact the sponsor who will facilitate the necessary permissions. Sponsor (fulfilled by the Research and Innovation department (R&I) on behalf of NUH) Assist the CI with compiling the end of study report should this be required. Undertakes an audit of the final report if required.

4 Page 4 of 6 Ensures the final study report is submitted to the relevant bodies within 12 months of the end of the study. 5. Definitions CI CONSORT CTIMP Documas EudraCT GCP ICH IMP MHRA NUH R&I REC RPM SOP TMF Chief Investigator Consolidated Standards of Reporting Trials Clinical Trials for Investigational Medicinal Product A document management system to assist with the management, control and governance of the research and ethics processes covering research and development projects European Clinical Trials Database Good Clinical Practice International Conference on Harmonisation Investigational Medicinal Product Medicines and Healthcare products Regulatory Agency Nottingham University Hospitals NHS Trust Research and Innovation Research Ethics Committee Research Project Manager Standard Operating Procedure Trial Master File

5 Page 5 of 6 6. Procedure It is a condition of the European Commission, MHRA, REC, and NUH approval that the results of a study are written up and made available. For randomised studies, the Consolidated Standards of Reporting Trials (CONSORT) statement principles should be followed to facilitate the transparent reporting of randomised studies. The MHRA and REC do not provide an end of study report template. The NUH End of Study Report template (TAFR02701) has been created with guidance from the MHRA, REC and ICH Guideline for the Structure and Content of Clinical Study Reports (E3) and incorporate the CONSORT checklist, therefore this template should be used for presenting the results of all NUH sponsored studies. The template is meant as guidance and not all sections will be appropriate for all studies. Where a section is not relevant, this should be deleted. 6.1 Compiling the End of Study Report The CI completes the end of study report (TAFR02701) and should ensure that data tables are checked for accuracy (this could be completed by the research fellow, research nurse or data manager for the study but must be documented). As per SOP-RES-017 Non-Compliance and Serious Breach Reporting all deviations that occurred during the study should be referenced in the final study report. The study statistician should also be aware of any non-compliance as this may affect the analysis of the data. The CI should facilitate appropriate review by any collaborators, funders and journals before the report is finalised. The report must be version controlled in accordance with SOP-QMS-002 Document Version Control. The report final draft is then sent to R&I via the researchsponsor@nuh.nhs.uk inbox for review within 10 months of the end of the study. The RPM will check that the report complies with the appropriate guidelines and procedures before authorising the report to be published and submitted to the MHRA /European Clinical Trials Database (EudraCT), and/or REC, and any other relevant parties as per study agreements. Any change requests will be sent to the CI. If a statement of GCP compliance is included in the final study report the RPM will liaise with the QA Auditor who will assess if an audit is required (refer to SOP-QMS-004 Audits and Inspections).

6 Page 6 of Submission of the End of Study Report R&I will authorise submission of the final study report to the MHRA/EudraCT, and/or REC (that issued a favourable opinion). R&I will submit the final study report to the MHRA/EudraCT and/or REC, and any other parties, however this may be delegated to the CI or third party (as defined in an agreement); In addition R&I will upload the end of trial summary results to EudraCT as per the commission s guidelines on posting and publication of resultrelated information. Submission of the final study report to the MHRA for medicinal products which falls under Directive 2001/20/EC will be via the EudraCT database. However you must send a short confirmatory to CT.Submission@mhra.gsi.gov.uk once the resultrelated information has been uploaded to EudraCT, with End of trial: result-related information: EudraCT XXXX-XXXXXX-XX as the subject line. You will not get an acknowledgment or letter. Submission to REC is via attaching the relevant documentation. Submission must be within 12 months of the end of the study, unless it is a paediatric CTIMP, in which case submission may be required within 6 months of the end of the study. All end of study reports will be stored in the Trial Master File (TMF), both electronically and in the hard copy file, and uploaded to Documas. 7. References and Associated Documents Further information on the CONSORT statement can be found on the CONSORT website European Commission Communication 2009/C28/01 International Conference on Harmonisation Guideline for the Structure and Content of Clinical Study Reports (E3) Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006External link icon TAFR02701 SOP-QMS-002 SOP-QMS-004 End of Trial Report Document Version Control Audits and Inspections