This site uses session cookies and persistent cookies to improve the content and structure of the site. Please Note: all substantial amendments must be reviewed by your R&IS departmental officer prior to submission Non-CTIMP. EC approval is required before the change can be implemented NO = If not indicated otherwise, non-substantial changes must be notified to the ethics committee in the annual safety report (KlinO Art. Amendments SOP R&D GCP SOP 08 version 4, 04.02.19 Page 6 of 16 6 Non-substantial amendments 6.1 Examples of non-substantial amendments are given in Appendix 3. University Research Committee correcting errors, updating contact points, minor clarifications; updates of the investigator's brochure (unless there is a change to the risk/benefit assessment for the trial); changes to the chief investigator’s research team (other than appointment of key collaborators); changes to the research team at particular trial sites (other than appointment of a new principal investigator in a CTIMP); changes in the documentation used by the research team for recording study data; changes in the logistical arrangements for storing or transporting samples; extension of the study beyond the period specified in the application form. Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or other study staff are minor amendments but should be notified to the REC that approved your original application. Amendments may be made to the conduct of a clinical trial. WHAT ARE THE SUPPORTING DOCUMENTS REQUIREMENTS? They can be ‘substantial’ or ‘non-substantial’. provide detailed instructions on submission of amendments. Please let us know if you agree to functional, advertising and performance cookies. Non Substantial Amendment 3. changes to the design or methodology of the study, or to background information affecting its scientific value; changes to the procedures undertaken by participants; significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers; a change of sponsor(s) or sponsor’s legal representative; appointment of a new chief investigator or key collaborator; a change to the insurance or indemnity arrangements for the study; temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt; a change to the definition of the end of the study; any other significant change to the protocol or the terms of the REC application. Non-Substantial Amendments to the Action Plan are defined as minor, one that does not materially change the activities or eligible beneficiaries. This guidance does address aspects related to Ethics Committees only insofar as the provisions contained in Directive … NON-SUBSTANTIAL AMENDMENT #3 ACTION PLAN INTRODUCTION The Disaster Relief Appropriations Act, 2013 (Pub. They can be ‘substantial’ or ‘non-substantial’. Non-substantial Amendments Non-substantial Amendments include the following • Correction of typographical errors in the protocol or other study documentation • Non-substantial clarifications of the protocol • Updates of the investigator’s brochure (unless there is … Amendment No. We use cookies to give you the best online experience. You should summarise the change(s) included in the amendment and briefly explain the reasons in each case on the notice of amendment. 5. § 2.2.2). Changes introduced on the request of AFSSAPS or the CPP A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study. Stay up to date with latest news, updates to regulations and upcoming learning events, REC that approved your original application. Ideate Queries correcting errors, updating contact points, minor clarifications; updates of the investigator’s brochure (unless there is a change to the risk/benefit assessment for the trial); changes to the chief investigator’s research team Karen dot Julian at warwick dot ac dot uk, Coronavirus (Covid-19): Latest updates and information, inclusion of a new trial site (not listed in the original application) in a CTIMP, appointment of a new principal investigator at a trial site in a CTIMP, inclusion of new sites and investigators in studies other than CTIMPs, NHS HRA: UK Process for Management of Amendments. A substantial amendment is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: 6 (Non-Substantial) to Community Development Block Grant Disaster Recovery Action Plan JEFFERSON PARISH LOUISIANA . correcting errors, updating contact points, minor clarifications; updates of the investigator’s brochure (unless there is a change to the risk/benefit assessment for the trial); changes to the chief investigator’s research team. Tel: (024) 765 75732 However, they do not need REC, HRA or MHRA approval. Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or other study staff are minor amendments but should be notified to the main NHS REC for information. You do not need to submit a substantial amendment if the sponsor retains an existing UK IMP release site for the UK trial and includes an EU/ EEA release site for trials in the EU/ EEA. What is the procedure? changes to the research team at particular trial sites (other than appointment of a new principal investigator in a CTIMP); changes in the documentation used by the research team for recording study data; changes in the logistical arrangements for storing or transporting samples; inclusion of new sites and investigators in studies other than CTIMPs; extension of the study beyond the period specified in the application form. The conduct or management of the trial. Research Professional Examples of non-substantial amendments: minor changes to the protocol or other study documentation, e.g. It is important that you complete the form using language comprehensible to a lay person. HSC Research & Development, Public Health Agency, Northern Ireland. Notification of. Introduction: On May 29, 2013, HUD issued FR 5696-N-03, notifying Jefferson Parish, Louisiana of an - allocation of $16,453,000.00 from the Disaster Relief Appropriations Act of 2013. Which is likely to affect, to a significant degree: The safety, or physical or mental integrity, of any subject of the trial. Examples of substantial and non-substantial amendments to be notified to AFSSAPS Page 7 of 22 ASSESSMENT OF A NOTIFICATION OF SUBSTANTIAL AMENDMENT(S) BY AFSSAPS SUBSTANTIAL AMENDMENTS REQUIRING AFSSAPS AUTHORISATION (SAA) The procedures regarding SAA are described in Volume 1 of the Notice to Sponsors (cf. University of Warwick Urgent Safety Measures. Some changes, however, will have no significant implications for participants or for the conduct, management or scientific value of the study and can be regarded as ‘non-substantial’ or ‘minor’ amendments. It is the responsibility of the Sponsor to classify the amendment which will determine the action required. CV4 8UW R&IS Staff, Research Ethics Committees If you want to make changes to your approved research file that are non-substantial, you can do so via a non-substantial amendment. Please complete our short feedback form. The sponsor is required to keep records of all substantial and non-substantial amendments to the trial, and provide such records to HSA if requested. The Health Research Authority website uses essential cookies. An amendment to a research project can be either substantial or minor (non-substantial) in nature. Introduction: On May 29, 2013, HUD issued FR -5696-N-03, notifying Jefferson Parish, Louisiana of an allocation of $16,453,000.00 from the Disaster Relief Appropriations Act of 2013. Notification of Amendment (Not Substantial) Partner Organisations: Health Research Authority, EnglandNIHR Clinical Research Network, England. L. No. These should be sent to all participating organisations on receipt to ensure the participants' safety. We are still testing the new HRA website to ensure it meets your needs. It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial. These changes count as a substantial amendment to your clinical trial authorisation. Our MREC checks if the submission and the documents are in order. Examples of substantial and non-substantial amendments are available on the HRA website. 2.1. Classification of Amendments for Clinical Trials with Medicinal Products according to the Austrian Medicinal Products Act (AMG) Example substantial non-substantial Increase in duration of the trial > 10 % provided that… 1. the exposure to treatment with the IMP is not extended, 2. the definition of the end of the trial is unchanged, and 3. Substantial amendments require approval (from the relevant bodies) before they can be implemented except in the case of Urgent Safety Measures. For further details please see NHS HRA: UK Process for Management of Amendments. The scientific value of the trial. They are classified as either substantial or non-substantial, depending on the nature of the change. 113-2, approved January 29, 2013) allocated funding for the Community Development Block Grant program. Examples of Non-substantial amendments This site uses cookies. Email: Karen dot Julian at warwick dot ac dot uk, Research & Impact Services *It is the responsibility of the sponsor to decide whether a substantial amendment requires authorisation, or an ethical opinion, or both. Non-Substantial: This CDBG DR Action Plan modification is classified as a Non-Substantial Amendment as referenced on page 114 of the CDBG DR Action Plan. Non-substantial amendments do not have to have prior authorisation, but must be recorded They should, however, be documented by the sponsor and be made available to AFSSAPS on request. ‘Notice of Substantial Amendment’ forms can be created in the Integrated Research Application System (IRAS). CHANGES OTHER THAN SUBSTANTIAL AMENDMENTS Non-substantial amendments Non-substantial amendments (NSA) do not require notification to AFSSAPS (neither for authorisation nor for information). Substantial Modifications and Amendments CHANGES TO THE INVESTIGATIONAL MEDICINAL PRODUCT WITH A NEED TO REQUEST A SUBSTANTIAL AMENDMENT TO THE IMPD The European Medicines Agency (EMEA) provides detailed guidance for notification to the competent authorities regarding changes to an IMP’s Product Specification File as the development of the … Departmental Administrative Officer & PA to the Director Substantial Amendment Notification Form : PDF version - Word version (revision 3 of June 2010) Declaration of the End of Trial Form : PDF version - Word version (revision 19 of June 2019) Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (revision 1 of … Substantial amendments refer to amendments: Which change a local sponsor or principal investigator of the trial. You need to send a notification of amendment form, a revised application form … You should notify both the main NHS REC and the relevant local NHS REC if the principal investigator’s contact details have changed. 7 (Non-Substantial) to Community Development Block Grant Disaster Recovery Action Plan JEFFERSON PARISH LOUISIANA . Amendments are changes made to the research after a favourable ethical opinion has been given. amendment referred to in point (a) of Article 10 on substantial amendments made to the protocol; (c) the declaration of the end of the clinical trial.’ 2. The sponsor of the clinical trial should ensure that the details and rationale for the amendment(s) are clearly described in the submission. However, non-substantial amendments should be recorded and [...] contained in the documentation when it is subsequently submitted, for example in the subsequent notification of a substantial amendment. Amendments are changes made to the research after a favourable ethical opinion has been given. The system also provides guidance on substantial amendments and their submission. R&IS staff bulletin. You must inform the main NHS REC of all substantial amendments by completing a notice of substantial amendment.