Clinical Data Transparency

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

Tool Description
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

You may review our submission here, as well as read more about Regulation EU No 536/2014 on the website for the European Commission’s Directorate for public health and risk assessment.

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