Safety Reporting in Investigator-Initiated Trials (IIT)

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:

The intricacies of conducting various types of investigator-initiated trials (IITs), their adverse event reporting requirements, and documentation processes for all responsible parties will be discussed.

Topics:

1. Definitions
   • Sponsor
   • Investigator
   • Sponsor-Investigators
2. Investigator-Initiated Trials (IITs) vs. Federally Funded Trials vs. Industry Trials
3. Types of IITs
   • Investigator holds the Investigational New Drug Application (IND)/ Investigational Device Exemption (IDE)
   • Cross-Reference IND/IDE
4. Intricacies of conducting IIT
5. Adverse event (AE) data collection
   • Federal mandate (21CFR 312.64)
   • FDA Form 1572
6. Adverse Event (AE) record keeping
7. Unexpected vs. Expected updates on IITs
8. Source documentation of AE and serious adverse event (SAE)
   • ALCOA + C- Attributable, Legible, Contemporaneous, Original, and Accurate + Complete
9. AE vs. SAE Reporting
10. Source documentation vs. Data capture
11. Standardizing grading (severity)
    • Common Terminology Criteria for Adverse Events (CTCAE)
    • Serious vs. Severity
    • Example exercise
12. Relationship (Causality)
13. Reporting: When and to Whom?
14. Who should review AEs and SAEs on IIT?

Speaker:

Nonna Snider, BS/BA, is the Assistant Director for Clinical Research Operations at the Clinical Investigations Support Office (CISO) at USC Norris Comprehensive Cancer Center.  Mrs. Snider has over 17 years in pre-clinical and clinical drug development.  She received her BS in Biochemistry and BA in History from University of California, Davis. She started her research career at Allergan in the Nuclear Receptor Research working within a multidisciplinary group focused on drug discovery research primarily in the areas of dermatology, oncology and metabolic disease.  She than transitioned to project management at Vitae Pharmaceuticals and NuRx Pharmaceuticals, gaining experience in conducting pre-clinical and clinical research with special focus in dermatology and oncology in US, India and Latin America, taking a dermatology and two oncology compounds through pre-clinical and Phase I and II clinical trials. As part of her role, Mrs. Snider managed U.S. investigational sites and central laboratories as well as Global CROs interfacing with FDA and local regulatory and clinical entities to ensure compliant and timely conduct of pre-clinical and clinical trials. In 2010, Mrs. Snider joined USC as Quality Assurance Monitoring Committee Coordinator and Data and Safety Monitoring Committee Coordinator at Norris Cancer Center, and worked within a multidisciplinary team to further grow the QA program and help develop DSM Plan cultivating with successful submission to NCI.Currently Mrs. Snider is part of the CISO leadership team responsible for ensuring safe and compliant implementation of Phase I, II, and III oncology clinical trials conducted at USC. nonnasni@usc.edu

Audience:

This course is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Learner Level: Beginner

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 (6) course program. To complete the entire program and earn a badge CLICK HERE.

Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz

·       Complete the evaluation at the end

Certificates will be distributed at the end of the evaluation.

Enduring Materials Dates:

·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027