Development Safety Update Report Guidance

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1 Development Safety Update Report Guidance This document provides instructions for the preparation and submission of a Development Safety Update Report (DSUR) for a Clinical Trial of an Investigational Medicinal Product (CTIMP). A template for and detailed guidance on the contents of the DSUR is also included. This document may be used for all clinical trials for which a Keele CTU staff member has been delegated the Sponsor duty for annual safety reporting of Adverse Events (AEs) for a CTIMP and where no other template is in effect. Abbreviations and Definitions: AE CTA CTIMP DSUR ICH Countries IB IMP MHRA Adverse Event Clinical Trial Authorisation Clinical Trial of an Investigational Medicinal Product Development Safety Update Report Counties using the guidelines set up by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Investigator Brochure Investigational Medicinal Product Medicines and Healthcare product Regulatory Agency Non-commercial clinical trial In accordance with Directive 2001/20/EC, a non-commercial clinical trial is defined as a trial: Conducted by a non-commercial organisation, with no industry sponsor, that is not part of the development program for a marketing authorisation of a medicinal product; or, If potentially leading to a marketing application, where the holder of the intellectual property/patent is a not-for profit organisation REC Research Ethics Committee RSI Term used within EC Detailed Guidance (CT3) June 2011, meaning the applicable product information which is used to determine the expectedness of an Adverse Reaction. This information is normally obtained from within the SPCs or IB; when referring to the IB the relevant section must be defined. It may be a separate document in its own right. It must be defined at the start of a trial. SAE SAR Serious Adverse Event Serious Adverse Reaction

2 SmPC SUSAR UoB Summary of Product Characteristics Suspected Unexpected Serious Adverse Reaction University of Birmingham Background: Sponsors of CTIMPs must submit a DSUR to the competent authority of the member states in which the trial has a Clinical Trial Authorisation (CTA). A summary of this information must also be submitted to the ethics committee of the concerned member states. The aim of the DSUR is to provide a review, and evaluation of, all new available safety information received during the reporting period. It should also provide an ongoing assessment of the risk to trial subjects; describing concisely the results of such analyses and summarising the evolving safety profile of the IMP or combination of IMPs. For trials conducted in the UK, the full DSUR should be submitted to the Medicines and Healthcare product Regulatory Agency (MHRA) and the Research Ethics Committee (REC). For trials run in other concerned countries; a full DSUR should be submitted to the competent authority but the requirements for submission to the ethics committee may differ and should therefore be confirmed at the time the DSUR is required to be submitted. The DSUR: Replaces the requirement to submit an Annual Safety Report in the UK and other EU countries (working under the EU Clinical Trials Directive) and the US IND Annual Report in the USA. It is also effective in all other ICH Countries Came in to effect on 1 st September 2011 for trials run within the EU. Annual Safety Reports will no longer be accepted by the competent authority Is developed with pharmaceutical companies in mind, and aside from published DSUR examples for non-commercial Sponsors (see references) there is no official guidance available for noncommercial trials. It is recognised however by official bodies such as MHRA (during the GCP noncommercial symposium in November 2011 and the European Medicines Agency information day in July 2011) that the current guidelines cannot always be followed for non-commercial trials. The following is therefore assumed In situations where the Sponsor does not have access to the information to be included in specific sections (e.g. the Sponsor might not have information on manufacturing issues, nonclinical data, and marketing status), this should be clearly stated in the report The DSUR should concentrate primarily on the IMP(s) within the trial; it is expected that there will only be one DSUR per trial in the non-commercial setting The DSUR is submitted annually for the duration of the clinical trial until the End of Trial notification has been submitted. In the commercial setting, the Development International Birth Date is used to determine the start of the annual period for the DSUR. This date is the sponsor s first authorisation to conduct a clinical trial in any country worldwide. The start of the annual period for the DSUR is the month and date of the Development International Birth Date For non-commercial trials it is suggested to submit annually from the date that the first CTA was received for the trial from a competent authority (i.e. MHRA for UK only trials). If the trial is conducted in multiple countries this should be the date the first approval was received in any of the participating countries When submission of an annual report is no longer required, it should be stated that the final DSUR serves as the last annual report for the trial in question (if this is known at the time of preparation of the report). It should be indicated whether or not clinical trials are continuing elsewhere, if known In the EU, the DSUR should contain the following information:

3 The report: an analysis of the subjects safety in the context of the concerned clinical trial as per the DSUR Table of Contents (see Template) Appendices: the order and nomenclature of the appendices are as per the DSUR guideline. Some appendices are contained in the body of the main report; the list below refers to mandatory appendices supplied as separate documents a. Appendix 1: Current and any revisions to the Reference Safety Information (RSI)* b. Appendix 5: A line listing of all Serious Adverse Reactions (SARs) and all Suspected Unexpected Serious Adverse Reactions (SUSARs) that were reported in the concerned trial during the reporting period* c. Appendix 6: A cumulative tabulation of all SAEs including SARs and SUSARs that have been reported since the start of the trial* d. Appendix 7: Scientific abstracts* (if relevant) e. Appendix 8: A cumulative tabulation of all SARs and SUSARs that have been reported since the start of the trial* Responsibilities: Chief Investigator: On a yearly basis report safety information to the relevant competent authority(ies) and ethics committee(s) Ensure all relevant documentation including acknowledgment receipts from the competent authority(ies) and ethics committee(s) are filed in the Trial Master File Inform the Sponsor of any potential significant safety issues that may have to be reported to any other trials in the Sponsor s portfolio using the same IMP Inform relevant third parties of any relevant safety data or significant safety issues as appropriate Provide Quality Assurance Manager and/or any external Sponsor (as per agreements) with a copy of the DSUR Maintain confidentiality of trial data Note the CI may delegate the preparation of the DSUR to appropriate members of the trial management team, but the CI retains the responsibility for reviewing the DSUR prior to submission. There may be circumstances (e.g. where safety is the primary end point for the trial) where it is not felt appropriate for the CI to review the aggregated summaries of the DSUR, in which case another independent clinician should be appointed to assume this role. Sponsor: As per their local procedures: Ensure safety information is reported annually to the relevant competent authority(ies) and ethics committee(s) When informed of any potential significant safety issues that may have to be reported to any other trials in the Sponsor s portfolio using the same IMP, ensure further reporting is undertaken Upon receipt of the DSUR, process accordingly Procedure: Reporting time frame Take a snapshot of data for analysis on the anniversary of the date the trial first received approval from a competent authority If the trial has yet to open to recruitment submit a letter explaining this to the competent authority and the ethics committee in place of the DSUR

4 Submit the DSUR to the competent authority(ies) and ethics committee(s) within 60 days of the date of the snapshot End of reporting period: For UK only trials, submit a DSUR annually until the trial is closed with the competent authority For international trials, the last report can be submitted at the end of the reporting period during which the last patient completed treatment in the concerned member state Preparing the report Where the CI (or Keele CTU) is delegated the duty of preparing the DSUR on behalf of the Sponsor: Generate a report based on this template; the information contained in the DSUR should: Be written from a Sponsor perspective: Where the Sponsor does not have access to the information to be included in specific sections (e.g. manufacturing issues, non-clinical data, and marketing status), this should be clearly stated Where the Keele University or other non-commercial Sponsor is not the Manufacturing or Marketing Authorisation holder for the IMP(s), there will be sections of the DSUR which cannot be completed; this information need not be actively sought unless contractually agreed to be provided by a third party Only capture the IMP(s) within the trial (as stated in the CTA application, including placebos), i.e. do not include any non-imps used in the trial For non-commercial trials, it is expected that the DSUR will be produced on a trial-by-trial basis, providing information on the IMP or combination of IMPs within the named trial Include an entry under every heading, even if this is to state that the requested information is not available Note the same information may be asked in different places in the form; do not re-enter the information, but refer to the section where the information has been entered for the first time. Check for updates to the relevant Reference Safety Information (RSI): (i.e. (sections of) Summary of Product Characteristics (SmPCs) or Investigator Brochure (if provided externally); where necessary obtain updated versions from the manufacturer Collate information regarding the evolving safety profile of the IMP(s) and where necessary: Perform relevant literature searches Obtain relevant information, from a third party (e.g. pharmaceutical company) if contractually agreed Where possible, obtain from the Sponsor of this trial a summary of any other DSUR which has been prepared for other trials sponsored by the same Sponsor that utilise the same IMP(s). This includes both ongoing and completed trials. Preparing the appendices Generate line listings, i.e. list all SARs and their details underneath each other; see appendix 5. Ensure that all SAEs (including SARs and SUSARs) are reported from countries for which the Sponsor is responsible If the line listing or summary tabulations are produced electronically, perform checks to ensure accuracy of data, for example cross check a minimum of 2 events for accuracy of all data fields and ensure total number of listed events is as expected. If errors are indentified, amend report as appropriate. Obtain signature(s) Chief Investigator (or delegate); note there may be circumstances (e.g. where safety is the primary end point for the trial) where it is not felt appropriate for the Chief Investigator to

5 review the aggregated summaries of the DSUR, in which case another independent clinician should be appointed to assume this role For externally sponsored trials, the Sponsor may also request to sign the report Reference Safety Information (RSI) The RSI is the safety information that is used to assess expectedness of adverse reaction. This information is embedded in an IB or SmPC. As part of the DSUR reporting check on the anniversary of the CTA if this safety information as embedded in the IB or SmPC has changed over the last year in such a way that the expectedness of adverse reaction has changed as well. Where the RSI has changed: Submit a substantial amendment to the competent authority at the same time as submitting the DSUR. The amendment should reference and be supported by the DSUR Note: the revised RSI can only be implemented once approval from the competent authority has been received Attach old and revised RSI as Appendix 1 of the DSUR Where the RSI has not changed, attach the (unchanged) current RSI to the DSUR Submitting the report in the UK Prepare/obtain the relevant documentation: DSUR (signed) Scan signature page Create signed PDF version Appendices Create PDF version Supporting documentation (e.g. current and any revisions to the RSI) Write a cover letter specifying that the DSUR has been prepared on a trial specific basis Complete the National Research Ethics Service Clinical Trials of Investigational Medicinal Products Safety Report Form available on the NRES website (at time of writing this is Submitting to the MHRA Documentation must be submitted electronically in PDF format on a data CD Recorded delivery is recommended Submit to Information Processing Unit, Area 6, Medicines & Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ The MHRA do not routinely acknowledge the receipt of DSURs, therefore consider including a DSUR acknowledgment slip (or add acknowledgment receipt to the cover letter) and selfaddressed envelope with the CD and instructions for the MHRA to return in order to acknowledge receipt Alternatively send an to ct.submission@mhra.gsi.gov.uk detailing the EudraCT and submission date and request acknowledgement of receipt The details above are correct at the time of writing but should be checked prior to submission; see MHRA website for current details: eporting-susarsandasrs/index.htm The MHRA should acknowledge receipt of the report when supplied with an acknowledgement slip or a request is made via ; if this is not received request for this again upon receipt

6 Submitting to the REC Send the National Research Ethics Service Clinical Trials of Investigational Medicinal Products Safety Report Form available on the NRES website (at time of writing this is Documentation must be submitted electronically in PDF format via (extensive documents may be submitted via data CD; 3 copies should be provided) Appendix 1: the RSI appendices need not be sent to the REC Submit to the relevant REC (refer to NRES website for REC addresses) The REC should acknowledge receipt of the report by signing and returning a copy of cover form within 30 days; if this is not received it should be requested Filing documentation File all documentation (i.e. original signed DSUR, signed copy of the cover letter to MHRA, acknowledgment of receipt from the MHRA and signed (returned) REC covering form) in the Trial Master File It is recommended that all documents are filed together in the Trial Master File (e.g. in DSUR section) Informing third parties The DSUR is a confidential document potentially containing information split by treatment arm hence it should only be sent to third parties where this is a contractual requirement. It should not be forwarded to sites Forward copy of DSUR to third parties (e.g. Sponsor, DMC, international collaborators) as required Highlight any significant safety issues as appropriate Template Use the DSUR Report template as a basis for producing the DSUR Within the document instructions and notes are in blue text Instructions from the DSUR guidance document (ICH E2F) is referenced in grey text Delete the notes and instructions before use In the report all sections in the Table of Contents are mandatory Maintain all headers If no relevant information is available, this must be stated All sections/questions must be kept in the order that they appear in this QCD All appendices marked * are mandatory Maintain order and nomenclature For both the report and appendices: Insert the relevant trial specific information where specified by <text> or <text> Be concise and do not repeat information; cross reference where necessary Throughout the template replace the text Investigational Medicinal Product (IMP) with the specific drug name(s) as appropriate Ensure naming of drugs is consistent in the use of generic or brand names and in keeping with the protocol, CTA and other trial documentation The format of the report can be modified to make it consistent with other trial specific documentation

7 Obtain signed approval for the final report from the Chief Investigator (or delegate) and Sponsor if applicable Note that there may be circumstances (e.g. where safety is the primary end point for the trial) where it is not felt appropriate for the Chief Investigator to review the aggregated summaries of the DSUR and sign the DSUR, in which case another independent clinician should be appointed to assume this role References: (2011/C 172/01) Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3). Version ICH Harmonised Tripartite Guideline: Development Safety Update Report E2F current Step 4 version dated 17th August 2010 DSUR Examples Non-commercial Sponsors: at time of writing SUR/E2F_Example_non-commercial_DSUR.pdf

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