U.S. Food & Drug Administration

Activity Outline
Clinical Investigator Training Course (CITC) Update
December 7 - 8, 2021
Webcast

Activity Coordinator:

Lisa Misevicz (Lisa.Misevicz@fda.hhs.gov)

Description

The Clinical Investigator Training Course is designed for physicians, nurses, pharmacists and other healthcare professionals involved in clinical trials. Lectures presented by senior FDA experts as well as guest lecturers from industry and academia explore the scientific, regulatory and ethical aspects of clinical trials. They also include discussions of non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA regulatory requirements related to the performance and evaluation of clinical studies.

References

Title 21, Chapter I, Subchapter A, parts 50 (protection of human subjects), 54 (financial disclosure by clinical investigators), and 56 (IRBs)
Title 21, Chapter I, Subchapter D, parts 300-499 (drugs for human use)
Title 21, Chapter I, Subchapter F, parts 600-680 (biologics)

Learning Objectives

Explain the responsibilities of an investigator conducting a clinical trial.
Describe what to look for in drugs being studied in a clinical trial.
Describe the basic concepts of clinical trial design.
Review clinical data for sources of bias and error.

Target Audience
This activity is intended for physicians, pharmacists, and nurses.

Agenda
Day 1 December 7, 2021

Time	Topic	Speaker
1:00 - 1:10 PM EST	Day One Overview	Brenda Stodart, PharmD, MS, BCGP, RAC
1:10 - 1:20 PM EST	CITC Overview	Leonard Sacks, MD
1:20 - 1:50 PM EST	Gene Therapy	Lei Xu, MD, PhD
1:50 - 2:20 PM EST	CarT Therapy	Lianne Hu, MD, PhD, MPH
2:20 - 2:35 PM EST	Q&A	Lei Xu, MD, PhD Lianne Hu, MD, PhD, MPH Peter Bross, MD
2:35 - 2:50 PM EST	Break
2:50 - 3:15 PM EST	Innovations in the Design of Clinical Trials in Oncology	SANDRA CASAK, MD
3:15 - 3:55 PM EST	COVID 19 Treatment	Kirk Chan-Tack, MD Sarita Boyd, PharmD
3:55 - 4:10 PM EST	Q&A	Sarita Boyd, PharmD Kirk Chan-Tack, MD SANDRA CASAK, MD
4:10 - 4:40 PM EST	Trial Populations – Diversity, Sex Differences, Pediatrics and Q&A	Mathilda Fienkeng, PharmD Lynne Yao, MD Kaveeta Vasisht, MD
4:40 - 4:55 PM EST	Q&A	Mathilda Fienkeng, PharmD Lynne Yao, MD Kaveeta Vasisht, MD
4:55 - 5:00 PM EST	Day 1 Summary/Closing remarks	Leonard Sacks, MD

Day 2 December 8, 2021

Time	Topic	Speaker
12:50 - 1:00 PM EST	Day 2 Overview	Brenda Stodart, PharmD, MS, BCGP, RAC
1:00 - 1:15 PM EST	Master Protocols	Gregory Levin, PhD
1:15 - 1:30 PM EST	Decentralized Clinical Trials (DCTs), Digital Health Technologies (DHTs)	Leonard Sacks, MD
1:30 - 1:45 PM EST	Real World Evidence	John Concato, MD
1:45 - 2:00 PM EST	Drug Repurposing	Heather Stone, MPH
2:00 - 2:15 PM EST	Demo Session on Portal to Submit Research Investigational New Drugs (INDs)	Shoma Foss, MS
2:15 - 2:45 PM EST	Q&A	Leonard Sacks, MD Shoma Foss, MS Heather Stone, MPH John Concato, MD Gregory Levin, PhD
2:45 - 3:00 PM EST	Break
3:00 - 4:00 PM EST	Investigator Responsibilities Including as Applied during Covid-19	Cynthia Kleppinger, MD
4:00 - 4:20 PM EST	Q&A	Cynthia Kleppinger, MD
4:20 - 4:30 PM EST	Wrap Up	Leonard Sacks, MD

Continuing Education Accreditation

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 7 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 7.00 AMA PRA Category 1 Credit(s)^™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-21-077-L04-P for 7.00 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 7.00 contact hour(s).

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

Boyd, Sarita, PharmD, Associate Director, FDA - nothing to disclose
Bross, Peter, MD, Medical Team Leader, FDA/CBER/OTAT/DCEPT/OB - nothing to disclose
CASAK, SANDRA, MD, Team Leader, FDA - nothing to disclose
Chan-Tack, Kirk, MD, Medical Officer, FDA - nothing to disclose
Concato, John, MD, Supervisory Physician, CDER-OMP - nothing to disclose
Fienkeng, Mathilda, PharmD, Division Director, FDA - nothing to disclose
Foss, Shoma, MS, Senior Business Informatics Analyst, OSP/OBI - nothing to disclose
Hu, Lianne, MD, PhD, MPH, Clinical Analyst, FDA/CBER/OTAT/DCEPT - nothing to disclose
Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
Levin, Gregory, PhD, Associate Director for Statistical Science and Policy, FDA/CDER/OTS/OB - nothing to disclose
Sacks, Leonard, MD, Associate Director for Clinical Methodology, CDER/FDA - nothing to disclose May reference off-label use.
Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
Stone, Heather, MPH, Health Science Policy Analyst, FDA/CDER - nothing to disclose May reference off-label use.
Vasisht, Kaveeta, MD, Associate Commissioner for Women's health, FDA Office of Women's Health - nothing to disclose
Xu, Lei, MD, PhD, Medical Officer, FDA - nothing to disclose
Yao, Lynne, MD, Director, DPMH, CDER/OND/ODE4/DPMH - nothing to disclose May reference off-label use.

Planning Committee

Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
Sacks, Leonard, MD, Associate Director for Clinical Methodology, CDER/FDA - nothing to disclose May reference off-label use.
Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team

Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.

Requirements for Certificate of Completion (Non CE)
Must attend 80% of the activity.

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