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Medical Writing:

Study protocol, informed consent form (ICF), Investigator’s Brochure (IB), serious adverse events (SAE) reports etc.

Summary

  • Describe the overall structure of a protocol and regulatory requirements
  • Describe the requirements for a protocol, including:
  • Establishing the indication(s), purpose, objectives and outcome measures
  • Understand the types of studies
  • Develop the protocol design (single blind, double blind, randomized, etc.)
  • Identify the hypothesis
  • Establish safety and efficacy outcomes and how they will be measured
  • Determine inclusion/exclusion criteria
  • Determine the Schedule of Events
  • Determine safety assessments
  •   Review required and optional elements of informed consent, criteria for language and comprehension by research subjects
  •   Review of serious adverse event reporting requirements and narrative writing  

Overview

This webinar is an integrative learning experience, combining a comprehensive review of the good clinical practice and required elements for clinical study protocol, Investigator’s Brochure (IB), informed consent elements and adverse event narrative writing.

Who should attend?

  • Medical Directors

  • Medical Writers

  • Clinical Research Associates

  • Regulatory Affairs Professionals

  • Research and Development Personnel

  • Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers

  • Grant Administrators

Marina Malikova

Expert

Dr. Malikova has over 15 years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products.  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration.  She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS).

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