DDF57 – NEW All clinical trials in Europe at your fingertips: Introduction to the public portal of the Clinical Trial Information System (CTIS)

Description

Knowing about this important source is important for regulatory medical writers, medical affairs associates, writers and other professionals working in the realm of disclosure, and quality assurance specialists. The public portal offers highly structured, reliable and approved information about clinical trials in Europe. Participants will learn about the key features of CTIS, the way the public portal can be searched for various items including key trial documents. In addition, the clinical trials map in Europe will be introduced and demonstrated. Participants will learn to optimally display their searches and to download documents. They will also get an idea about the limitations of the CTIS public portal.

Participant profile: The workshop is for anybody who is interested to learn about the key functionalities of the CTIS public portal. This may be for his or her own benefit as a potential trial participant, as a patient advocate, a medical affairs professional interested in competitor activities, a medical writer who wants to see how other companies approach the provision of key information on clinical trials, a transparency and disclosure professional evaluating results postings both in the scientific and lay summary by other companies. A basic understanding of clinical research is helpful, eg about clinical phases, indications, the relevance of inclusion and exclusion criteria. Ideally participants are familiar with the key documents in a clinical trial, ie the study protocol, informed consent form, etc. People with some knowledge about the way information is entered in CTIS may benefit a lot too.