Investigator Responsibilities: Investigator Initiated Trials

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

This course discusses key roles and responsibilities of individuals associated with investigator initiated trials pertaining to 21 CFR 312.50, FDA 1572.

Topics:

1. What is an FDA 1572 (21 CFR 312.50) Statement of Investigator form?
2. When don’t you use the 1572 form?
   • Investigation Device Studies
   • Non-IND Studies
3. Why does the investigator need to fill out a 1572 form?
   • Dual purpose of completing the form
   • Right upper corner shows current form
4. Filling out the FDA 1572 form
   • Read the FAQs – Guidance for Sponsors, Investigators and IRBs
5. 1572 Commitments
   • Avoiding Warning Letters to Clinical Investigators
   • When to sign the 1572 form.
   • The “Legal” part
6. Key points to understanding 1572 Commitments
   • 21 CFR 312.64: Progress Reports, Safety Reports, Financial Disclosure Reports, Final Reports
   • 21 CFR 312.62: Disposition of Drug, Case Histories, & Record Retention
   • 21 CFR 312.68: Inspection of Investigator Records and Reports
   • 21 CFR Part 56: IRB Compliance

Speaker: 

Nancy Smerkanich, DRSc, MS, is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California (USC). Dr. Smerkanich received her faculty appointment after successfully completing her Doctoral Dissertation on “Benefits Risk Frameworks –Implementation in Industry” in 2015.  In addition to teaching in courses related to drug development and clinical trials, she continues to provide regulatory guidance to industry peers. Nancy brings many years of practical regulatory knowledge and experience to academia where she participated in all regulatory aspects of product development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Known for her dedication to education and mentoring across industry, Nancy continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as the Drug Information Association (DIA) and The Organization for Professionals in Regulatory Affairs (TOPRA). With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Prior to joining Octagon, Dr. Smerkanich held various Regulatory Affairs positions within industry, including nine years at Merck and seven years as an independent consultant. Dr. Smerkanich holds a Doctorate and Master’s degree in Regulatory Science from USC and Bachelor of Science Degree in Microbiology and a Bachelor of Arts in Russian from the University of Connecticut. piresmer@usc.edu 

Audience:

This symposium is designed for Clinical Research Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with at least 3 years of clinical research experience.  Individuals should be experienced with research study coordination, IRB submission process, budgeting, research compliance, recruiting, enrolling, financial management, data collection and analysis. 

Learner Level: Intermediate

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.  Attendees to this CNE activity will be awarded 0.5 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the second course in a six session program. To complete the entire program and earn badge Click Here.