Clinical Investigator Training Course (CITC) Update
December 7 - 8, 2021
Webcast
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.
- 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)
- 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.
This activity is intended for physicians, pharmacists, and nurses.
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, PharmD |
4:40 - 4:55 PM EST | Q&A |
Mathilda Fienkeng, PharmD Lynne Yao, MD Kaveeta Vasisht, MD, PharmD |
4:55 - 5:00 PM EST | Day 1 Summary/Closing remarks | Leonard Sacks, MD |
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 |


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.
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.
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, PharmD, 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 is complimentary; therefore refunds are not applicable.
Must attend 80% of the activity.