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The use of the clinical trial information system (CTIS) is now mandatory for all initial clinical trial applications in the European Union (EU), as of the 31st January 2023.. With this and the EU CTR, plain and lay language summaries are introduced at the start and the end of a clinical trial.. Plain Language Protocol Summary (EU CTR Annex I, D24) A plain language protocol synopsis helps any ...

Good Lay Summary Practice 29 October 2021, Version 1 ... to the CTIS via the EU Portal no later than 12 months from the protocol-defined end of the clinical trial, 6 months for paediatric studies, and up to 30 months for non-therapeutic Phase 1 trials. More detailed rules about the publication of

To ensure readability of the lay summary, sponsors are highly encouraged to involve laypersons, in particular patients or patient organisations, early on in the development and the review process. 6 Publishing of lay summary via CTIS is obligatory, but different ways of dissemination e.g. sharing on a website, direct mailing to study ...

The content requirements of the Lay Summary of Clinical Trial Results are outlined in full in Annex V of the Regulation, but in contrast, the Protocol Synopsis is only mentioned in one line in Annex 1 (D.24), which states simply, “the protocol shall be accompanied by a synopsis of the protocol”.

The European Clinical Trial Regulation now requires sponsors to provide a lay summary of clinical trials in a set time period following the trial end. ... This dissemination is facilitated by the European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) that was launched at the end of January 2022. Sponsors are required to ...

The EU Clinical Trials Regulation 536/2014 (EU CT Regulation) requires that a Lay Summary (LS) must be provided for every clinical trial conducted within the European Union and henceforth included in the publicly accessible EU database, a core element of the EU “Clinical Trials Information System” (CTIS). The lay summary or simply referred as ‘LS’ is a document that is written in plain ...

#CTIS insights Trial results How to submit trial results and lay person summary of results 7 How to manage a clinical trial Sponsors must submit a summary of results and a lay person summary within one year from the end of a CT (in all EEA MSC or globally, if applicable), and within 6 months in case of paediatric trials. 3.

Once the template has been finalised, the process for reviewing each lay summary should be clarified before it’s sent to CTIS, the compulsory submission platform for trial documentation. Creating a template will help to reduce costs, lower the time taken to generate and translate lay summaries, as well as provide a greater level of consistency.

Article 37 of the CTR requires sponsors to submit a lay summary (LS) for each clinical trial involving medicinal products included in the EU Clinical Trials Database (part of the Clinical Trials Information System, CTIS, available from January 31, 2022). The LS must be submitted to CTIS generally no later than 12 months after the protocol ...

Mandatory as of 31 January 2022, this Lay Summary must be uploaded to the Clinical Trials Information System (CTIS) at the latest one year after the end of the trial (6 months for paediatric studies). This regulation is a major step forwards in transparency. It is an opportunity to explain drug development to the general public, and hopefully ...

The portal, named Clinical Trials Information System (CTIS), was launched on 31 January 2022. Clinical trial sponsors could use CTIS from 31 January 2022, but were not obliged to use it immediately. There is a 3-year transition period from the Clinical Trials Directive to the EU CTR: ... A PLS, also known as a Lay Summary, is a short document ...

2022 marks the start of a new era in clinical trials in Europe with the implementation of EU Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) going live on 31 January 2022. Significant new rules have come into effect alongside a series of non-legislative initiatives, bringing the hope of more efficient processes and greater patient benefit.

CTIS public portal: Trial Results . This section includes the trial’s summary of results and layperson summary of results, as submitted by the sponsor on CTIS, and could include the Clinical Study Report, if submitted by the relevant Marketing Authorisation Holder. See the relevant definitions in the table below.

These lay person 48 summaries will be made available in the EU Portal and Database. 49 Annex V of the Regulation sets out the ten elements that must be addressed in the lay 50 summaries. This document includes recommendations and templates to help authors when 51 writing the lay summary. Consistency in the way that trial results are presented ...

Along with a Lay Summary, a technical summary of the results of all interventional studies, from phase I to phase IV, will need to be submitted within 12 months of the end of the study to the Clinical Trial Information System (CTIS) established by the European Medicines Agency (EMA), in accordance with Annexes IV and V to the above-mentioned ...

Lay person summary of results . Access Trial results results Steps that users need to follow Guide to access the ‘Trial results’ sub-tab. Summary of for users to be able to view and submit the summary of results. Roles & permissions This section provides an explanation of which roles can view, submit, update and withdraw the summary of results.

Recommendations, Good Practice, …. •Guidance Good Lay Summary Practice adopted by the EU Clinical Trials Expert Group (v.1, Oct. 2021) •Recommendations Summaries of clinical trials results for lay persons of the expert group on clinical trials for the implementation of the EU CTR (v2, 2018) •Summaries of Clinical Trials Results for Laypersons. ...

CTIS public portal: Trial Documents . This section includes the documents of the clinical trial application that are subject to publication: protocol, protocol synopsis, Summary of Product Characteristics (if available), Recruitment arrangements, Subject information and informed consent form. Their lay language descriptions are available in

trial, the sponsor must submit to CTIS a summary of the results of the trial, within one year from the end of a clinical trial in all Member States concerned or within six months for a trial in paediatric population. The summary of results shall be accompanied by a summary written in a manner that is understandable to laypersons.