Investigator initiated trials- What are we doing to ensure human subject protection ?



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.

Areas to be Covered:

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
  • 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

Who will Benefit:

This topic applies to personnel / companies doing research or involved in the clinical trials. The following will benefit:

  • Principal 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

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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance