Investigator- Initiated Trials - What are we Doing to Ensure Human Subject Protection?
Dr. Nagina Parmar has years of clinical research experience as a certified clinical research professional in academia and hospital. Her expertise as a clinical research professional lies in coordinating various Phase I, II and III national and international clinical trials and investigator-initiated trials. During her career as CCRP, she was also involved in developing SOPs (Standard Operating Procedures), REB SOPs and research elements database. She is an active member of the Society of Clinical Research Associates (SoCRA) and Network of Networks (N2N). As an Adjunct faculty, Dr. Parmar is also involved in teaching Biology, Microbiology, Life Sciences for Clinical practice, and drug development courses at various academic institutions. Her writing appeared in more than 30 journal articles, books, and reviews in numerous national and international journals. As a mentor, Dr. Parmar has provided references and letter of recommendations to assist students with their endeavors. Dr. Parmar has given various career development seminars at University of Toronto to graduates and postgraduates and webinar with the Association of Clinical Research Professionals (ACRP).
Investigators initiated trials are very essential of any research to be translated from bed to bedside. The inception of these research is 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 the 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 the protection of human subjects in clinical trials participation how sponsors, investigators, and a site can ensure vigilance in this process.
This webinar will introduce the learners regarding the main areas of investigator-initiated trials and the necessary steps taken to ensure compliance with federal regulations and the International Conference on Harmonization and Upon completion of this webinar, attendees should be able to:
- Recognise the importance of investigator-initiated trials
- Identify a way to ensure human subject protections
- Identify the investigator deficiencies
- Identify what the site responsibilities in investigator-initiated trials are
- Identify the approaches or concerns of Institutional Review boards
- Recognise the resources available to help the investigator in the conduct of the investigator-initiated trial
Who Should Attend
This topic applies to personnel/companies doing research or involved in the clinical trials. The following will benefit most include:
- Senior Clinical Research Associates(CRAs)
- Clinical Research Coordinators (CRCs)
- Data Managers
- Contract Research Organizations (CROs)
- Institutional Review Boards (IRBs)
- Site Management Organizations (SMOs)
- Project Managers
Why Should Attend
This webinar will help you understand the key issues and challenges associated with investigator-initiated trials. Investigator-initiated trials are significant as they are an essential 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 trial.