Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance

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). Additionally, 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.

To follow the regulations of Good Clinical Practices (GCP) is common sense. To not know and follow these regulations is folly. Attend this webinar to understand the 13 areas described in The ICH GCP Guidelines of E6 (4.1 to 4.13). understand the legal language, role and responsibilities and difference between AEs and SAEs and reporting requirements.

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, 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, working with various Principal Investigators, IRB applications, grant submission, business development and fundraising.  She served on a study coordinator advisory committee of a global CHF/hyponatremia clinical trial.

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