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.
Why attendees should register:
The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound or was hard to implements at different clinical sites. Knowing how to effectively write a clinical trial protocol and informed consent form are crucial elements to achieving IRB and FDA/EMA approval.
Investigator’s Brochure (IB) must be reflective of current drug safety profile and updated with regards to new safety alerts. Serious adverse events reporting is essential to ensure subjects safety and must be done in connection with IB updates. This session will provide an overview for IB contents and review of serious adverse events reporting requirements, attribution categories selection (i.e. causality, expectedness, etc.) and essential components of narrative writing.
Description of the topic:
This session is focused on required and optional elements of clinical study protocol and informed consent form, contents of Investigator’s Brochure, and overview of serious adverse events reports and narrative writing
Areas Covered in the Webinar Session:
· Describe the overall structure of a protocol and regulatory requirements
· Describe the requirements for a protocol, including:
o Establishing the indication(s), purpose, objectives and outcome measures
o Understand the types of studies
o Develop the protocol design (single blind, double blind, randomized, etc.)
o Identify the hypothesis
o Establish safety and efficacy outcomes and how they will be measured
o Determine inclusion/exclusion criteria
o Determine the Schedule of Events
o Determine safety assessments
Who will benefit:
· 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
Target Audience to market:
Research and Development Personnel
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
Marina Malikova, Ph.D., MSci, MA, CCRA, RAC - Executive Director, Surgical Translational Research: Operations and Compliance.
Dr. Malikova has over 20 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. 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 also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.
She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012.
Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.