Substantial amendments require approval (from the relevant bodies) before they can be implemented except in the case of Urgent Safety Measures. The sponsor of the clinical trial should ensure that the details and rationale for the amendment(s) are clearly described in the submission. 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. Our MREC checks if the submission and the documents are in order. changes to the design or methodology of the study, or to background information likely to have a significant impact on its its scientific value; changes to the procedures undertaken by participants; changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study; 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; a change to the insurance or indemnity arrangements for the study; 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; 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. 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. Catherine Cochrane 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. 6.2 Version number and date of amended documents must be up-dated for non- substantial amendments according to the SOP on Version Control (GCP SOP 01). University Research Committee Please Note: all substantial amendments must be reviewed by your R&IS departmental officer prior to submission Non-CTIMP. 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 … An amendment is a change to a research project after the initial approval has been given from a review body. You should summarise the change(s) included in the amendment and briefly explain the reasons in each case on the notice of amendment. They can be ‘substantial’ or ‘non-substantial’. This site uses session cookies and persistent cookies to improve the content and structure of the site. These should be sent to all participating organisations on receipt to ensure the participants' safety. They are classified as either substantial or non-substantial, depending on the nature of the change. Such amendment should contain a brief description of the change and reference (date and number) to the submission that contained the original protocol. It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial. Substantial amendment: YES or NO or "it depends" Yes = Generally, the change must be submitted as a substantial amendment. Departmental Administrative Officer & PA to the Director These funds are for necessary expenses related to disaster relief, long-term recovery, restoration of infrastructure, If you need to notify a Substantial Amendment to your study then you MUST use the appropriate Substantial Amendment form in 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). 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 … 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. 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. The quality or safety of any investigational medicinal product used in the study Coventry What is the procedure? minor changes to the protocol or other study documentation, e.g. 3.3 A non-substantial amendment is defined as a change to the details of the study which will have no significant implications for participants, the scientific value, conduct or management of the trial, or quality and safety of the Investigational Medicinal Product in a CTIMP. The Health Research Authority website uses essential cookies. Amendment No. Please let us know if you agree to functional, advertising and performance cookies. Examples of substantial and non-substantial amendments are available on the HRA website. You should submit the non-substantial amendment digitally. 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. Notification of Amendment (Not Substantial) Partner Organisations: Health Research Authority, EnglandNIHR Clinical Research Network, England. 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. Amendments are changes made to the research after a favourable ethical opinion has been given. Which is likely to affect, to a significant degree: The safety, or physical or mental integrity, of any subject of the trial. You need to send a notification of amendment form, a revised application form … Changes introduced on the request of AFSSAPS or the CPP It is the responsibility of the Sponsor to classify the amendment which will determine the action required. An amendment to a research project can be either substantial or minor (non-substantial) in nature. However, they do not need REC, HRA or MHRA approval. Amendment Acknowledgement and Implementation Information R&IS staff bulletin. Tel: (024) 765 75732 6 (Non-Substantial) to Community Development Block Grant Disaster Recovery Action Plan JEFFERSON PARISH LOUISIANA . Director of Research & Impact Services, Please contact Karen Julian, 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: the safety or physical or mental integrity of the subjects of the trial; the conduct or management of the trial; or. Please complete our short feedback 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. We are still testing the new HRA website to ensure it meets your needs. L. No. 2.1. Non-Substantial Amendments to the Action Plan are defined as minor, one that does not materially change the activities or eligible beneficiaries. Non-substantial amendments do not need to be notified. 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. Financial Regulations for Research 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. non-substantial / minor. provide detailed instructions on submission of amendments. Notification of Non-Substantial/Minor Amendments(s) for NHS Studies This template must only be used to notify NHS/HSC R&D office(s) of amendments, which are NOT categorised as Substantial Amendments. Non-substantial amendment. If you want to make changes to your approved research file that are non-substantial, you can do so via a non-substantial amendment. Amendment No. 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. 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. Stay up to date with latest news, updates to regulations and upcoming learning events, REC that approved your original application. 5. By continuing to browse the site you are agreeing to our use of cookies. You must inform the main NHS REC of all substantial amendments by completing a notice of substantial amendment. NON-SUBSTANTIAL AMENDMENT #3 ACTION PLAN INTRODUCTION The Disaster Relief Appropriations Act, 2013 (Pub. 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. 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. Non-substantial amendments should be notified to the Sponsor where they may affect indemnity. § 2.2.2). R&IS Staff, Research Ethics Committees The scientific value of the trial. WHAT ARE THE SUPPORTING DOCUMENTS REQUIREMENTS? HSC Research & Development, Public Health Agency, Northern Ireland. Urgent Safety Measures. Ideate Queries Non-substantial amendments do not have to have prior authorisation, but must be recorded Substantial Amendment A Substantial Amendment can be defined as an amendment to the terms of the REC application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: 1. Confirmation of Amendment Categorisation as Category B Non-substantial amendment notification Minor amendment covering letter Summary of changes to the Patient Information Sheet Non Substantial Amendment 4. minor changes to the protocol or other study documentation, e.g. The amendments help section in the Integrated Research Application System (IRAS) will tell you whether you need to notify a review body and if so, in what capacity. *It is the responsibility of the sponsor to decide whether a substantial amendment requires authorisation, or an ethical opinion, or both. 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 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 … These changes count as a substantial amendment to your clinical trial authorisation. Non Substantial Amendment 3. University House Non-substantial amendments. You should notify both the main NHS REC and the relevant local NHS REC if the principal investigator’s contact details have changed. It is important that you complete the form using language comprehensible to a lay person. This guidance does address aspects related to Ethics Committees only insofar as the provisions contained in Directive … Notification of. For further details please see NHS HRA: UK Process for Management of Amendments. Amendments may be made to the conduct of a clinical trial. 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. NHS Research Scotland NISCHR Permissions Co-ordinating Unit, Wales. 29). This site uses cookies. Examples of non-substantial amendments: minor changes to the protocol or other study documentation, e.g. 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: Email: Karen dot Julian at warwick dot ac dot uk, Research & Impact Services 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. For all studies, it is the responsibility of the sponsor to determine whether an amendment is substantial and confirm which approvals are required (prior to any submission being made by the delegated responsible party). University of Warwick 113-2, approved January 29, 2013) allocated funding for the Community Development Block Grant program. You can update your cookie preferences at any time. Substantial amendments refer to amendments: Which change a local sponsor or principal investigator of the trial. We aim to process your amendment within 10 working days. 7 (Non-Substantial) to Community Development Block Grant Disaster Recovery Action Plan JEFFERSON PARISH LOUISIANA . The conduct or management of the trial. A non-substantial amendment can be defined as a change to the details of a study which will have no significant implications for participants, for the conduct of the study, its management or scientific value. Examples of Non-substantial amendments Research Professional 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. 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. 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). the quality or safety of any investigational medicinal product used in the trial. Records of the amendment and when it was implemented must be kept in the Research File (Trial Master File for Clinical Trials). The notice of substantial amendment form can be submitted via IRAS for electronic authorisation by sponsor. Amendments are changes made to the research after a favourable ethical opinion has been given. 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. 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. Tel: (024) 765 24760 CV4 8UW They can be ‘substantial’ or ‘non-substantial’. We use cookies to give you the best online experience. The system also provides guidance on substantial amendments and their submission. 4.4.4 For non-substantial/minor amendments(s) the sponsor will authorise the Non-Substantial/Minor Amendments(s) for NHS Studies Form and return it to the CI 4.5 Submit Once authorised by the sponsor the amendments should be