Fact Sheet
Clinical Trial Disclosure Services
Helping you meet your transparency obligations today, and preparing for those of tomorrow
Jul 11, 2023

Clinical trial (CT) disclosure regulatory requirements continue to increase, with mandatory registries and an expanding scope of required disclosure data. This includes the EU Clinical Trial Regulation (CTR)1 as well as the transparency initiatives announced by the EMA2, Health Canada3 and PhRMA4.

As a result, sponsors are under increasing obligations to make CT data available to the public and other researchers that have not traditionally been disclosed on registries (such as ClinicalTrials.gov5 and euclinicaltrials.eu6).

The IQVIA clinical trial disclosure group is dedicated to providing you a single-source solution as you pull together the different required elements, including:

  • Protocol summary registration, including redaction of the applicable clinical trial application (CTA) documents and preparation of plain language summary of protocol synopsis
  • CT results reporting including making available redacted versions of the protocol, applicable amendments and the statistical analysis plan
  • Clinical study report anonymization/redaction for public disclosure, including Appendices 16.1.1, 16.1.2 and 16.1.9
  • Plain language summaries (for patients who participate in clinical trials)

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