STANDARD OPERATING PROCEDURE FOR THE ... - Accord

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ACCORD NHS Lothian R&D and The University of Edinburgh SOP Number: CR008v2.0 Effective Date: 14/SEP/2011 1. INTRODUCTION It is a requirement of maintaining both Research Ethics Committee approval and a Clinical Trials Authorisation (CTA) that reports are submitted at least annually. It is imperative that the Sponsor of a study is able to maintain oversight of these reports especially where their submission is the Sponsor’s responsibility. 2. PURPOSE To document the procedure for preparing and submitting annual progress reports and annual safety reports. It also outlines in what instances they are applicable and who is responsible for their completion and dissemination to relevant parties. 3. SCOPE This Standard Operating Procedure (SOP) applies to Chief Investigators (CIs), or designees, for all studies sponsored by NHS Lothian and/or the University of Edinburgh (UoE). CIs must ensure that annual progress reports are submitted. In addition, for studies that require a CTA, there is an additional obligation for the CI to prepare annual safety reports in the form of a Development Safety Update Report (DSUR). The SOP also applies to the ACCORD Governance and QA team. In order to ensure sponsor oversight, the ACCORD Governance and QA team are responsible for administering and logging this process; reviewing the content of the reports; submitting annual safety reports; and filing the paperwork. 4. REFERENCES EMEA, “Note for Guidance on Good Clinical Practice” (E6) R1, CPMP/ICH/135/95. The Medicines for Human Use (clinical trials) Regulations 2004. http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrial s/Safetyreporting-SUSARsandASRs/index.htm accessed 17/11/10, 1130hrs. http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progressreports/ accessed 17/11/10, 1100hrs. http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progressreports/#progressSafety accessed 17/11/10 1200hrs. http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrial s/ManagingyourCTA/Endoftrial/index.htm accessed 17/11/10, 1200hrs. Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the latest version Page 2 of 5
ACCORD NHS Lothian R&D and The University of Edinburgh SOP Number: CR008v2.0 Effective Date: 14/SEP/2011 5. <strong>PROCEDURE</strong> 5.1 Responsibilities 5.1.1 It is the responsibility of the Chief Investigator (CI) to ensure annual progress reports are completed and submitted to relevant parties. 5.1.2 For studies that require a CTA, it is also the responsibility of the CI to complete annual safety reports. The sponsor is responsible for submitting annual safety reports to the relevant parties 5.1.3 For studies that require a CTA, the Senior Clinical Trials Monitor or Quality Assurance (QA) Officer, or designee, will be responsible for ensuring that the Chief Investigator for each study is contacted and provided with a partially completed annual progress or annual safety report 6-10 weeks prior to the deadline for the report. 5.1.4 Prior to submission to the regulatory authority the annual safety report must be reviewed by the Senior Clinical Trials Monitor, or designee, or QA Officer. 5.2 Annual Progress Reports (All Studies) 5.2.1 Annual progress reports for all research studies must be submitted to the Research Ethics Committee REC that approved the study and the sponsor. 5.2.2 Annual progress reports must be submitted on the anniversary of receipt of a favourable ethical opinion from the main REC and then every year until completion of the study. 5.2.3 An annual progress report must be submitted for all studies, even if they have not started before the first anniversary of approval. The report should clearly explain the reasons why the study has not started. 5.2.4 For Clinical Trials of Investigational Medicinal products (CTIMPs) annual progress reports will be submitted to the REC using an NRES annual progress report form. This can be found on the NRES website http://www.nres.npsa.nhs.uk/applications/after-ethical-review/annual-progressreports/ 5.2.5 Where the responsibility for preparing the annual reports has been delegated to another party by the CI, the CI must review and sign the report before submission to the main REC. 5.2.6 The annual progress report will be acknowledged by the REC coordinator within 30 days. The REC may write to the CI for further information if they identify any issues with the report. 5.2.7 The CI must ensure that a copy of the annual progress report, acknowledgement from the REC, and any other relevant progress reports are sent to the sponsor for inclusion in the Trial Master File (TMF). 5.3 Annual Safety Reports (CTIMPs) Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the latest version Page 3 of 5
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