Discussion on role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (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). 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.
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