Biomedical Informatics in Clinical Trial Management

Biomedical Informatics in Clinical Trial Management
TERM PAPER ASSIGNMENT
Write a short research paper (single spaced and atleast 5 pages) on any of the (but not limited to)
following topics:
• Registration of Clinical Trials – what it is, its advantages and disadvantages (from the industry
and consumer perspectives).
• Relevance and usage (current and future) of Internet to Clinical Trials (besides what is given in
the course slides).
• Use of eCRF in Clinical Trials – what it is, its advantages and disadvantages in terms of clinical
trial data management.
• Techniques and tools employed in the post-marketing surveillance of drugs. List and briefly
describe any well known events pertaining to post-marketing surveillance.
• CDISC and its relevance to Clinical Trials
• Six Sigma Quality Improvement and its role in Clinical Trials.
List only 10 most important references (if you have more than 10) in any citation style of your choice.