Standard Operating Procedure:

Transcription

1 Standard Operating Procedure: Preparation and Submission of Annual Progress Reports for all Research Projects and Development Safety Update Reports SOP Number: SOP-QA-21 Version No: 1 Author: Date: (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: (Professor Julie Brittenden, R&D Director, NHS Grampian) Approved by: Date: (Professor Steve Heys, Head of School, University of Aberdeen) Issue Date: Effective Date: Review Due Date: Document History: Version Description of Changes Date Effective 1 Change of number for Q-Pulse Addition of other NHS areas to scope at 2.3 (Replaces UoA-NHSG-SOP-013 V2) This SOP will be reviewed at least every 3 years from initial and subsequent issue dates. Page 1 of 7

2 1. PURPOSE/INTRODUCTION 1.1 To describe the procedure for preparing and submitting Annual Progress Reports (APR) to the approving Research Ethics Committee (REC) for all research projects sponsored or co-sponsored by University of Aberdeen (UoA) and/or NHS Grampian (NHSG). 1.2 To describe the procedure for preparing and submitting Development Safety Update Reports (DSUR) for Clinical Trials of Investigational Medicinal Products (CTIMPs) which have obtained a Clinical Trials Authorisation (CTA). 1.3 This procedure complies with the current edition of the Scottish Executive Health Department s Research Governance Framework for Health and Community Care and the requirements of the Medicine for Human Use (Clinical Trials) Regulations 2004, as amended. 2. SCOPE 2.1 For the preparation and submission of APRs, this SOP applies to all researchers participating in research projects sponsored or co-sponsored by UoA and/or NHSG that have Research Ethic Committee (REC) approval For the preparation and submission of DSURs this SOP applies to researchers participating in CTIMPs sponsored or co-sponsored by UoA and/or NHSG. This also applies to other interventional studies involving a Medicinal Product (MP) that is also used in a CTIMP sponsored or co-sponsored by UOA and/or NHSG. (Hereafter referred to as Sponsor ). This SOP may also be used by staff from other NHS areas, or organisations, with prior agreement. 3. RELATED DOCUMENTATION 3.1 SOP-QA-7 SOP-QA-14 SOP-QA-19 TMP-QA-15 Establishing a TMF Requirement for SmPC, IPC and IMP Dossier for Research Projects Involving Medicinal Products Management Submission of Substantial and Non Substantial Amendments for all Research Studies including CTIMPs DSUR Template Copies of completed exemplar DSURs are available from the Sponsor. researchgovernance@abdn.ac.uk Page 2 of 7

3 4. REFERENCES Scottish Executive Health Department Research Governance Framework for Health and Community Care 2 nd Edition (2006) UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) as amended. Medicine and Healthcare Products Regulatory Agency website (MHRA) Current versions of these documents can be accessed via the Clinical Research Governance and Quality Assurance Website: Frequently asked questions regarding the Development Safety Update Report (DSUR) It is assumed that by referencing the principal regulations, all subsequent amendments made to the principal regulations are included in this citation. 4.1 ABBREVIATIONS AND DEFINITIONS APR CI CTA CTIMP DIBD DSUR IB MHRA MP NHSG R&D REC SmPC TMF UoA Annual Progress Report Chief Investigator Clinical Trial Authorisation Clinical Trial of an Investigational Medicinal Product Development International Birth Date Development Safety Update Report Investigator Brochure Medicines and Healthcare products Regulatory Agency Medicinal Product NHS Grampian Research & Development Research Ethic Committee Summary of Product Characteristics Trial Master File University of Aberdeen 5. RESPONSIBILITIES 5.1 Responsibility for completing and submitting APRs and DSURs is delegated by the Sponsor to the Chief Investigator (CI). 5.2 The Sponsor shall review APRs for all interventional studies and all DSURs prior to submission. Page 3 of 7

4 6. PROCEDURE 6.1 PREPARATION AND SUBMISSION OF AN ANNUAL PROGRESS REPORT (APR) TO THE NHS REC An APR shall be submitted annually for all research projects which have NHS REC approval. The first progress report is due 12 months after the date of the favourable opinion for the research project and shall be submitted within 30 days this date. The APR shall be submitted regardless of whether or not recruitment has started. If recruitment has not started, an explanation should be included in the APR The APR shall be completed on the appropriate NRES Annual Progress Report Form. The most recent versions can be obtained on the Health Research Authority website For non-interventional research projects, the CI shall ensure signed APRs are submitted to the NHS REC which provided the favourable opinion. Submission shall be made by sending a hard copy or by . The APR shall also be copied to the Sponsor and to any NHS R&D departments who have given management permission For all interventional research projects the CI shall forward the draft APR to the Sponsor for review at least 2 weeks prior to the required submission date. The Sponsor will review the draft APR and either confirm that the APR can be submitted or request changes and further review. The CI shall submit the signed APR to the NHS REC which provided the favourable opinion. Submission should be made by sending a hard copy or by . The APR shall also be copied to the Sponsor and to any NHS R&D departments who have given management permission All progress reports will be acknowledged in writing by the REC within 30 days of receipt of the report. Should the REC require further information they will write to the CI requesting a response. The CI may be required to attend a meeting of the REC to discuss the progress of the study The CI must ensure that a copy of the APR, acknowledgement and any other communication with the REC, Sponsor or R&D are filed within the Trial Master File (TMF) as detailed in SOP-QA-7 - Establishing and Maintaining a TMF Following receipt of the first APR, the Chair of the main REC has the discretion to waive the requirement for further APRs on receipt of a written request from the CI. This may be appropriate where a study has completed recruitment and assessments for the study, but has a long period of follow up with minimal participant involvement. Page 4 of 7

5 6.2 PREPARATION AND SUBMISSION OF A DEVELOPMENT SAFETY UPDATE REPORT (DSUR) TO THE MHRA AND THE NHS REC DSURs are required for CTIMPs sponsored by UoA and/or NHSG and other interventional studies involving a Medicinal Product (MP) that is also used in a CTIMP sponsored by UoA and/or NHSG DSURs shall be submitted annually. The first DSUR is due 12 months after the date of the Clinical Trials Authorisation (CTA) and shall be submitted within 60 days of this date. In the event of a DSUR submission incorporating more than one research project, the earliest CTA authorisation date will be used as the annual submission date. For research projects involving MP which have a Development International Birth Date (DIBD) this date may be used for the DSUR submission. The DSUR shall be submitted regardless of whether or not recruitment has started. If recruitment has not started, an explanation should be included in the DSUR The DSUR should be submitted in the format of the template (TMP-QA-15) associated with this SOP. Headings within this template should not be deleted. For each heading where information is available, the information should be presented concisely. Where the CIs team do not have access to information requested in specific sections (e.g. manufacturing issues, non-clinical data, marketing status) this should be stated in the DSUR as not applicable. Copies of completed exemplars are available on request from the Research Governance Team. The MHRA guidance on completing the DSUR is available as an associated document to this SOP In preparing the DSUR an annual check should be made on the Summary of Product Characteristics (SmPC) and/or the Investigator Brochure (IB) to ensure that the safety profile does not require to be updated (see SOP-QA-14 Requirement for SmPC, IB and IMP Dossier for Research Projects Involving Medicinal Products). The date of SmPC check should be recorded in the DSUR (section 7.1 of template TMP-QA-15). Any update to the IB should also be recorded in this section The CI shall forward the draft DSUR to the Sponsor for review at least 2 weeks prior to the required submission date. The Sponsor will review the draft DSUR and either confirm that the DSUR can be submitted or request changes and further review The CI shall submit the signed DSUR and any associated documents e.g. SmPC, IB, to the MHRA on a CD to the address below : Information Processing Unit Area 6 Medicines & Healthcare products Regulatory Agency Page 5 of 7

6 151 Buckingham Palace Road Victoria London SW1W 9SZ This submission should be made by courier or other signed for delivery service e.g. Royal Mail. Copies of the delivery request and proof of delivery should be held in the TMF and sent to the Sponsor via The receipt of DSURs will NOT always be acknowledged by the MHRA. However the CI will be contacted if there is a need to discuss an issue which arises on MHRA review of the DSUR The CI shall ensure DSURs are submitted to the NHS REC who provided the favourable opinion. The NHS REC form (CTIMP Safety Report to REC, available on the HRA website should be completed and sent with the DSUR. The format for the NHS REC submission may be electronic or hard copy depending on which NHS REC provided the favourable opinion. The REC should be approached for their preferred format. The REC will acknowledge receipt of the DSUR by signing and returning the CTIMP Safety Report to REC form The DSUR shall also be copied to the Sponsor and to any NHS R&D departments who have given management permission The CI must ensure that a copy of the DSUR, acknowledgement and any other communication with the MHRA, REC, Sponsor or R&D are filed within the Trial Master File (TMF) as detailed in SOP-QA-7 Establishing and Maintaining a TMF In the event of more than one sponsored or co-sponsored trial involving the same MP, the Research Governance Team will liaise with the CIs involved to ensure the production of a single report for all concerned trials For research projects which involve combination/multi-drug therapies it is usual for a single DSUR to be prepared and submitted. However, any exceptions to this (see examples in Appendix 1) should be discussed with the Research Governance Team in advance of preparing the first DSUR. Page 6 of 7

7 SOP-QA-21 APPENDIX 1 Multi-drug therapy used in clinical trial(s) Investigational drug (A) + marketed drug(s) (X, Y, Z). Two investigational drugs (A) + (B). Two (or more) marketed drugs as an investigational drug combination (X, Y, Z) DSUR Either a single DSUR focusing on (A+X+Y+Z) or A single DSUR focusing on (A) including data on the multi-drug therapy. Either a single DSUR focusing on (A+B) or Two separate DSURs (A) and (B), each including data on the multi-drug therapy. A single DSUR focusing on the multi-drug therapy (X + Y + Z). Page 7 of 7