mavii

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 ...

Purpose of the layperson summary Submission of trial results and layperson summary 5 • Inform research participants about the trial they participated in • Patient Engagement-Patient as partners in research • help to identify clinical trials easily and evaluate relevance for patient treatment • Public interest/Transparency on trial results

Lay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research. 1 This effort is supported by an increasing interest of study participants in study results and call for greater transparency. 2 ...

A PLS, also known as a Lay Summary, is a short document summarising the results of a clinical trial for people who are not scientists or medical professionals. ... The protocol and Patient Information Sheet (PIS)/Informed Consent form (ICF) should both say how the results of the trial will be shared with participants. 8. 2 Write. There are 10 ...

Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers); 2. Name and contact details of the sponsor; 3. General information about the clinical trial (including where and when the trial was ... •Mail of lay summary print-out or distribution of lay summary via the trial site •+ more ...

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. To support sponsors, a guidance cocreated and endorsed by the European Commission aims to help implement organizational capabilities to write and share lay summaries.

Lay summaries represent a valuable resource for increasing the visibility and impact. of your research. Excelya can be a one-stop partner for the coherent and cost-effective development of protocol and protocol lay summary or end-of-trial clinical. report development and corresponding lay summary in compliance with regulatory

1. Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers). 2. Name and contact details of the sponsor. ... The third and fourth pages of this lay summary (Figures 4 and 5) describe the study conduct, outcome assessments, and results using non-technical language.

Other lay friendly, patient facing documents are also likely to come to the fore in the near future. Per the EU Q&A document (originally released in January 2022[3]), sponsors are recommended to provide a summary of the clinical trial protocol in a format understandable to laypersons. This document is termed a lay protocol synopsis (LPS). If a

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”. In response to requests for more guidance, the

A lay summary is an overview of a research project described in a way that can be easily understood by those without prior experience of the subject. It is not a slight modification of the abstract or a simplification of the research; a well-written lay summary allows the public to understand research and its value, impact, and applications.

The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.

Writing your lay summary for your IACUC proposal can be a challenge. Your goal is to write a lay summary that any member of the public would be able to understand. Remember – one of the required members of the IACUC is the non-scientific member. ... Write the lay summary at the beginning or end of the creation of the protocol rather than in ...

Examples of Lay Summaries for Your IRB Protocol Submission . Biomedical Study Examples . Example 1: Sometimes people injure their knees by something poking into the joint. When the doctors suspect this has happened, they perform a test to see if there is a tear in the knee joint. During

The Lay Protocol Synopsis: Requirements and feasibility Lay titles for clinical trials: Is industry achieving the balance? To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective ...

The lay summary describes a single study – there is no context of wider clinical development to enable the reader to properly ... 1. Clinical trial identification (including title, protocol number, EU trial number and other identifiers). This section should have factual information, but how helpful it is for patients is questionable. If the ...

EFACCT Lay Protocol Summary Version 1.0 19/06/2017 Summary Protocol Evaluating patient follow-up and complexity in cancer clinical trials. EFACCT IRAS Reference: 218440 Background for the study Providing cancer patients with access to the latest treatment options through clinical research is an important focus for the NHS.

Clinical Trial Lay Summaries – a unique chance for transparency The Clinical Trials Regulation (CTR EU No 536/2014) is directly applicable in all EU/EEA Member States and obliges clinical trial sponsors to prepare a summary of the results of every clinical trial for the non-specialist/ general public audience. Mandatory as of 31 January 2022, this […]

Plus, the availability of a lay summary in a patient’s native language is an important element of fair access to information, and so the translation of these documents to the local official language(s) of each of the countries affected is required. ... “This also effects the plain language summary of the Protocol Synopsis among other ...