Section 1: Lay Summaries
Layperson Summaries of Clinical Trials: An Implementation Guide provides general principles helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation (EU CTR) No 536/2014.
Implementation Guide Supplemental Tools
|Investigator Education Material for Layperson Summary||Provides guidance to consider when developing an educational slide set on the overview of layperson summaries, potential content for the layperson summary, and investigator involvement|
|Sample Thank You Letter||Provides a sample Thank You Letter to thank participants for taking part in the study and provides information on how, when, and where the results and/or layperson summaries will be made available to participants|
|Study Participant – Frequently Asked Questions||Provides guidance when discussing the results of the study with the participants and answering study participants’ questions in a non-promotional manner|
|Introductory Letter to Investigative Sites||Provides a sample letter which may be used to communicate with investigators and site personnel about the plans of providing layperson summaries|
|Roadshow Slide Set||Provides a sample communication deck which describes the vision and overview of the layperson summary program|
Recommendations for Drafting Non-Promotional Lay Summaries of Clinical Trial Results, as referenced in the Layperson Summaries in Clinical Trials: An Implementation Guide, are intended to provide general principles to help sponsors prepare lay summaries in a manner that reduces the risk that the summaries could be perceived as promotional, which would raise regulatory concerns.
TransCelerate’s Clinical Data Transparency Initiative provides comments on the implementation of Regulation (EU) No 536/2014 for clinical trials on medicinal products for human use.
The comments that were submitted cover:
- Presentation of adverse reactions
- Timing of submission of lay summary for pediatric clinical trials
- Dealing with multiple endpoints
- Specific comments on the text within the Summary of Clinical Trials Results for Laypersons
Section 2: De-Identification & Anonymization
The following guidance documents and white papers are under review per Policy 70 direction.
Protection of Personal Data in Clinical Documents
- The revised paper Protection of Personal Data in Clinical Documents – A Model Approach reflects the latest thinking on protecting privacy, including EMA’s Policy 0070 guidance issued in March 2016 to support the publication of clinical documents. It represents current knowledge, experience, and technology available to date. It also includes points for a sponsor to consider while determining the appropriate anonymization approach for clinical documents.
- In September 2014, TransCelerate published Clinical Study Reports Approach to Protection of Personal Data, which is a general approach for protecting personal data in Clinical Study Reports (CSRs) that are shared with researchers, patients and others. The document describes an approach companies may apply when redacting or removing personal information from CSRs and other related clinical trial documents using techniques that were available at the time the paper was published.
De-Identification & Anonymization
- The revised paper De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach (V2.0) highlights which techniques are currently available to conform to existing directives and regulatory guidance and to respond to research requests while safeguarding the privacy of individuals for sharing in a non-public environment. The IPD paper better clarifies the data release context and expands sections considering the Expert Determination method, quantification of risk, and technology needs.
- In April 2015, TransCelerate published Data De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach (V1.0), which describes a model approach for the de-identification and anonymization of individual patient data for sharing with researchers. This paper considers how de-identification and anonymization techniques can be applied to individual patient data (IPD) to fulfil regulatory requirements relating to transparency and disclosure.