ComplianceOnline

Are you a Compliant Principal Investigator? What you Must Know and Do to Ensure Trial Compliance

Instructor: Madhavi Diwanji
Product ID: 702065
  • Duration: 60 Min

recorded version

$299.00
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Training CD

$499.00
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Read Frequently Asked Questions

This webinar will focus on the principal investigator's role and responsibilities, the legal language of FDA form 1572 or Device equivalent and how you can ensure a clean audit by following GCP.

Why Should You Attend:

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. The responsibilities are clearly described / outlined in The ICH GCP Guidelines of E6 (4.1 to 4.13).

This training, by a 20-year industry veteran, will cover the regulations and the PI's responsibilities for both drug and device clinical research in a user friendly way.

Areas Covered in the Seminar:

  • ICH guidelines and Good Clinical Practice (GCP).
  • The legal language of the FDA form 1572.
  • Role and Responsibility of the Principal Investigator.
  • Why investigator needs to sign and date documents? What documents?
  • Research Team management.
  • Key aspects of the role and key players involved in a trial.
  • Activities that are common to most trials.
  • Why is Financial Disclosure information important?
  • The difference between AEs and SAEs and the reporting requirement of the investigator.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Principal Investigators, Co-Investigators
  • Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs)
  • Administrative managers in charge of Clinical Research
  • Regulatory Compliance Associates and Managers
  • Clinical Research Scientists

Instructor Profile:

Madhavi Diwanji, BS, MBA, CCRC is the President of MD Clinical Monitor. She has tremendous experience in the healthcare industry in various roles for the past 20 years. She is well rounded in all aspects of clinical trial as she has been instrumental in healthcare research with a primary focus on cardiology for 8 years.

She has experience with monitoring clinical trials, conducting clinical trials, investigator initiated trials, maintaining multiple Trial Master Files, starting a research program in a hospital, health services research, regulatory /compliance submission and management, grant submission, business development and fundraising. She has successfully worked with different IRBs, CROs and sponsors.She has served on a study coordinator advisory committee of a global Congestive Heart failure clinical trial.

Topic Background:

In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”, one with “I have read and understand”, and one with “I will ensure”.

Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards), and 21 CFR 312 (Investigational New Drug Application / IND). For Device studies, 21 CFR 812 (Investigational Device Exemptions / IDE) is added in place of 21 CFR 312. Additional responsibilities are clearly outlined in the GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and not follow these regulations is folly.

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