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Webinar Description:
Areas Covered in the Session :
Investigator initiated trials- What are we doing to ensure human subject protection ?
Product Id FDB1320
Category Food, Drugs & Biologics
Scheduled On Wednesday, June 11, 2014 at 13:00 Hrs
Duration 60 Minutes
Speaker Dr. Nagina Parmar
This 1 hour virtual seminar will help you understand the key issues and
challenges associated with investigator initiated trials. Investigator initiated trials are
very important as they are important connection for the translation of research from
bench to bedside. I will discuss the role of sponsor-investigator and ways we can
ensure the protection of human subjects in an investigator initiated trials.
Investigators initiated trials are very essential of any research to be
translated from bed to bedside. The inception of these research are only done with
a scientific interest in a new or existing drug or device, generate new ideas, and
mostly involve collaborative research between different departments and also
different types of researchers. Despite availability of an ample amount of resources
that are available for some studies, but are lacking in the studies that are innovatory,
collective or questionable. To ensure protection of human subjects in clinical trials
participation how sponsors, investigators and site can ensure vigilance in this
process.
This webinar will introduce the learners regarding main areas of investigator
initiated trials and the necessary steps taken to ensure compliance with federal
regulations and the International Conference on Harmonization. Upon completion of
this webinar, attendees should be able to:
Recognize the importance of investigator-initiated trials
Identify way to ensure human subject protections

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Speaker Profile:
Who Will Benefit:
Identify the investigator deficiencies
Identify what are the site responsibilities in investigator initiated trials
Identify the approaches or concerns of Institutional Review boards
Recognize the resources available to help the investigator in the conduct
of investigator-initiated trials
This topic applies to personnel / companies doing research or involved in the clinical
trials. The following will benefit:
Principle Investigators(PIs)
Senior Clinical Research Associates(CRAs)
Clinical Research Project Manager
Contract Research Organizations (CROs)
Clinical Research Coordinators
Institutional Review Boards (IRBs)
Site Management Organizations (SMOs)
Dr. Nagina Parmar is a certified clinical research professional and senior clinical
research Associate. Dr. Parmar is involved in coordinating various phase II -IV
national and international clinical trials. She is also involved in developing SOPs
(Standard operating Procedures) and research elements database in the
hematology oncology department. Dr. Parmar is teaching Biology, Microbiology, Life
Sciences for Clinical practice, Principles of clinical research to undergraduate and
graduate courses at Ryerson University. She has published more than 30 journal
articles and reviews in various national and international journals and SOCRA
source. Dr. Parmar is an active member of the Society of Clinical Research
Associates (SoCRA) and Networks of Networks (N2). Dr. Parmar has given various
career development seminars at University of Toronto to graduates and
postgraduates, webinars and trainings and is actively involved in reviewing
textbooks for Pearson education Canada and John Wiley and Sons.