Course Description

This web seminar includes a high-level review of the key considerations and the current trends for the clinical study protocol, the Investigator’s Brochure (IB), the informed consent form, and adverse event narratives. While these documents form the basis and often predict the success of any drug or device development program, there is much variation between companies and individuals on how to approach writing these critical documents. In this web seminar, key considerations that should be taken into account in the development and maintenance of these documents will be discussed. 

Video Preview

Learning Objectives

• Describe current trends and key considerations for clinical study protocol writing
• Review required and optional elements of informed consent, criteria for language and comprehension by research subjects
• Review serious adverse event reporting requirements and narrative writing
• Discuss how to translate safety updates into informed consent and Investigator’s Brochure amendments

Who Should Attend

• Medical Directors and Physician Investigators
• Medical Writers/Regulatory Affairs Professionals
• Clinical Research Associates and Project Team Leaders
• Research and Development Personnel/Grant Administrators

Instructor

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.