Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator’s Brochure, Informed Consent Form, and Adverse Events Narratives

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.

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

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-023-L99-P. Released: 3/24.   

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