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Public Clinical Trial Registries: Results Reporting Requirements and Practical Demonstration

Level:
Foundation
Area:
Drug Development
Code:
DDF49
Duration:
03:30:00
Workshop profile:
This workshop is intended for participants wishing to learn about the requirements, timings, and processes for disclosure of clinical trial results in public databases in the US (ClinicalTrials.gov) and EU (EudraCT). Understanding basic clinical development stages and knowledge of regulatory documents (clinical study protocol, clinical study report, and statistical analysis plan) are essential. Previous experience in clinical trial results disclosure is not required.
Objective:
Upon completion participants will: · understand requirements for disclosure of trial results in the US and EU · be familiar with the content of US and EU trial results records · be able to enter data directly into ClinicalTrials.gov and EudraCT · recognise similarities and differences between the databases · realise the relevance of careful planning for public disclosure activities · appreciate the importance of content consistency across clinical trial documents in the public domain
Content:
The workshop will contain the following: i) brief Q&A session on legal regulations and non-legal requirements governing results disclosure for the US and EU ii) summary of the requirements and content of the US and EU clinical trial protocol registration and summary results records iii) practical tips on how to approach authoring of the results entries iv) live presentation of the database structure and study results entry v) considerations and implications for medical writers preparing results records, with practical examples