Training Workshops

In-depth review of the principal investigator’s regulatory obligations under FDA 21 CFR Parts 312 and 812, ICH E6(R2/R3) GCP guidelines, and institutional requirements. Covers the PI’s legal accountability for study conduct, delegation of authority and oversight of study staff, Form FDA 1572 obligations, and the investigator’s role in IRB/EC submissions and continuing review. Includes case studies of FDA Warning Letters and clinical holds resulting from investigator non-compliance.

Practical training on protocol interpretation, eligibility assessment leadership, and managing protocol deviations and amendments. Detailed instruction on the PI’s safety reporting responsibilities including adverse event assessment, causality determination, SAE and SUSAR reporting timelines, and communication with sponsors, IRBs, and data safety monitoring boards. Simulated safety scenarios requiring real-time PI decision-making.

The PI’s role in driving enrollment performance, including patient identification strategies, referral network development, informed consent process leadership, and managing screen failures. Operational training on study team management, delegation log maintenance, staff competency oversight, and sponsor/CRO relationship management. Covers the PI’s responsibilities during monitoring visits, site qualification visits, and investigator meetings.

Ensuring data integrity as PI — source documentation review, query resolution oversight, ALCOA+ principles, and electronic data capture responsibilities. Audit and inspection preparation: PI-specific interview techniques, document organization, response to findings, and CAPA oversight. Final module on building an investigator career: CV development, publication strategy, KOL positioning, and growing a multi-study portfolio. Concludes with a comprehensive assessment and certification.