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Clinical Trial Disclosure for Medical Writers: Results posting

Level:
Advanced
Area:
Drug Development
Code:
DDA16
Duration:
03:30:00
Workshop profile:
This workshop is intended for participants directly or indirectly involved in public disclosure of human subject research, or those with little or no background in this area who are interested in learning the basics. The workshop will serve as an introduction to the requirements for results disclosure (web disclosure of results information), highlighting the aspects most relevant for medical writers. Previous experience preparing results registration records for trial registers (e.g. clinicaltrials.gov) is not required.
Objective:
Upon completion of the workshop, participants will be able to: • Understand the basic principles and importance of Public Disclosure of Human Subject Research • Identify the key stakeholders, relevant regulations and guidelines, and key venues for disclosing results of clinical trial data (e.g. clinicaltrails.gov, company sponsored registries) • Distinguish the ‘must-haves’ for timely and accurate results disclosure • Understand the role medical writers can play in preparing high quality results registration records, as well as how trial disclosure requirements may influence the preparation of other clinical documents.
Content:
The workshop will begin with a brief overview of the development of trial disclosure requirements globally. The focus will then turn to regulations and guidelines that concern Public Disclosure of Results and how they impact the work of the medical writer. Specific topics covered will include: • Similarities and differences of key regulations pertaining to results registration (e.g. FDA Amendments Act, EU Directive, WHO requirements, National Registries) • Considerations for preparing results registration records (timing, content, revisions, consistency of information across multiple registers)