Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
EMA board discusses Clinical Trials Information System development – European Medicines Agency (EMA)
Formerly known as the EU clinical trial portal and database, the Clinical Trials Information System is currently in the pre-testing phase and will soon move to user acceptance testing once the outstanding bugs are addressed.
Read the full press release.
Reporting of scholarly work in medical journals addressed – International Committee of Medical Journal Editors (ICMJE)
The ICMJE outlines clinical trial registration and data sharing recommendations when considering publishing work in scholarly journals. One recommendation states that the “ICMJE uses the date trial registration materials were first submitted to a registry as the date of registration. When there is a substantial delay between the submission of registration materials and their posting at the trial registry, editors may inquire about the circumstances that led to the delay.”
Learn the full set of recommendations.
EudraCT updates migration tool – EMA
EudraCT’s version 7 migration tool was not working properly and the EMA issued an update recently. Their resolution, as part of a schedule maintenance release, included a modification to connect to the updated Eudralink via EudraCT’s public site.
Read the full release details.
Regulatory year in review – Outsourcing-Pharma
Editor Melissa Fassbender compiled a roundup of regulatory stories from 2018, highlighting FDA guidance on clinical trial disclosures, noncompliance with transparency guidance, EMA’s staff losses due to Brexit, civil monetary penalties, and much more.
Read more about transparency regulations.