By : Compliance Online
Date : 2011
Location : United States US / Palo Alto
Understanding of IRB application components and how to find out and fix problem areas before it threaten your trial to fail.
IRB, Expose, CRC, Compliance Training, conference, event, Webinar
Areas Covered in the Seminar:
- IRB- Purpose, Use, Responsibilities.
- IRB Application Process.
- Single center trial vs. Multiple center trial.
- Privately vs. Government sponsored trials.
- Research Team and IRB.
- IRB Document management.
- How to prevent problems.
- What to do prior to submitting application to the IRB, when the trial is on going and after the trial is complete.
- Continuing review, Annual Review.
Who Will Benefit:
This webinar will provide valuable assistance to all involved in conducting clinical trials at a research site:
- Research Managers
- Clinical Research Coordinators
- Principal Investigators, Co-investigators, Student Investigators
- Administrative managers in charge of Clinical Research
- Regulatory, Compliance Associates and Managers
- Personnel applying to IRBs for a single/multiple center trial
- Researchers working on a protocol
Why Should You Attend:
The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research and to maximize the safety of subjects once they are enrolled in the project.
Submitting an IRB application right the first time requires a lot of attention to detail. Once a successful application is approved, it is important to keep up with the continuing requirements/submissions/changes etc. Attend this webinar to learn what the IRB is looking for and how to expose and fix problem before they threaten you trial and learn about the role and responsibilities of an efficient well rounded CRC.
Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has worked in the healthcare industry in various roles for the past 20 years. She has worked in healthcare research with a primary focus on cardiology for 7 years. She has experience with conducting clinical trials, investigator initiated trials, starting a research program in a hospital, health services research, grant submission, business development and fundraising. She served on a study coordinator advisory committee of a global CHF/hyponatremia clinical trial.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria