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GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

This course is suitable for individuals proposing to conduct clinical trials of drugs, biologics, and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.


About this Course


The GCP U.S. FDA Basic course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs, biologics, and/or medical devices. It is intended for research personnel involved in drug, biologic, or device studies and who would benefit from FDA-focused training. It covers key topics in clinical research including:

  • Reviewing FDA regulations
  • Identifying investigator and sponsor obligations
  • Discussing new drug development
  • Comparing International Council for Harmonisation (ICH) GCP E6 and FDA regulations
  • Describing how to detect and report adverse events
  • Auditing and monitoring expectations

This course (English, Spanish, and Portuguese only) meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. The course (all languages) is also considered acceptable training by the National Institutes of Health (NIH) in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) that says NIH-funded investigators and staff should be trained in GCP.

Language Availability: English, French, Korean, Portuguese, Spanish, Thai, Vietnamese

Suggested Audiences: IRB Members, Research Staff who are Involved in the Design, Conduct, Oversight, or Management of Clinical Trials with Drugs and/or Biologics, Clinical Research Coordinators, Clinical Research Organizations (CROs), Investigators, Key Study Personnel, Research Nurses, Sponsors

Organizational Subscription Price: Included in organizational subscription
Independent Learner Price: $110 per person


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first.

Physicians

AMA PRA Category 1 Credit

4 Credits
(8 CE certified modules)
$80

6 Credits
(12 CE certified modules)
$90

1 July 2016
30 June 2019

Psychologists

CE Credit/Hour

6 Credits
(12 CE certified modules)
$90

1 July 2016
30 June 2019

Nurses

Contact Hour

4 credits
(8 CE certified modules)
$70

14 December 2015
14 December 2017

Other Participants

Certificate of Participation

4 Credits
(8 CE certified modules)
$70

6 Credits
(12 CE certified modules)
$80

1 July 2016
30 June 2019


Course Content


Toggle Content The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices CME/CEU Badge

Provides an introduction to the course and a link to the Belmont Report. The Belmont Report is required reading for all CITI Program participants as it provides the ethical framework for the federal regulations designed to protect human research subjects.

Recommended Use: Required
ID (Language): 1350 (English), 12149 (Spanish), 16335 (Portuguese), 16028 (Korean), 13440 (Thai), 13505 (French), 16558 (Vietnamese)

Toggle Content Overview of New Drug Development CME/CEU Badge

Describes the role of industry sponsors in the conduct of clinical trials under an investigational new drug (IND) application according to FDA regulations. Provides an overview of definitions, procedures, and timelines associated with the development of a new drug. Also covers electronic records and signatures pursuant to 21 CFR Part 11 and ClinicalTrials.gov requirements pursuant to 42 CFR Part 11.

Recommended Use: Required
ID (Language): 1351 (English), 12159 (Spanish), 16336 (Portuguese), 13433 (Thai), 13514 (French), 16559 (Vietnamese), 16029 (Korean)

Toggle Content Overview of ICH GCP CME/CEU Badge

Explains the role, purpose, and basic requirements of ICH E6 GCP guidelines and the impact on conducting clinical research according to GCP. Discusses when ICH GCP guidelines apply and an introduction to how these differ from the FDA regulations.

Recommended Use: Required
ID (Language): 1352 (English), 12720 (Spanish), 16337 (Portuguese), 16030 (Korean), 13438 (Thai), 13509 (French), 16560 (Vietnamese)

Toggle Content ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations CME/CEU Badge

Expands on the discussion presented in ICH Overview comparing ICH GCP E6 guidelines and U.S. FDA regulations 21 CFR Parts 50 and 56. Presents the major differences between ICH guidelines and FDA regulations, including critical areas such as confidentiality of medical records, signature of the person conducting the consent discussion, and impartial witnesses for illiterate subjects. Included are the differences between ICH GCP E6 and the FDA in terms of emergency situations, non-therapeutic trials, investigator notification to subject’s primary physician, and IRB responsibilities.

Recommended Use: Required
ID (Language): 1354 (English), 12153 (Spanish), 16338 (Portuguese), 16031 (Korean), 13442 (Thai), 13508 (French), 16259 (Khmer), 16115 (Vietnamese)
Author(s): David G. Forster, JD, MA, CIP - Western IRB; Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group, Inc.

Toggle Content Conducting Investigator-Initiated Studies According to FDA Regulations and GCP CME/CEU Badge

Discusses topics important to researchers who are also the sponsors of studies (sponsor-investigators) and conducting investigator-initiated studies. Covers how to determine whether an investigational new drug (IND) application is required, the role of the sponsor-investigator, documentation required for INDs, and reports that must be submitted to the FDA for active INDs. Also includes information on the additional responsibilities that sponsor-investigators assume in their dual role.

Recommended Use: Required
ID (Language): 1355 (English), 12154 (Spanish), 16339 (Portuguese), 16032 (Korean), 13436 (Thai), 13507 (French), 16561 (Vietnamese)

Toggle Content Investigator Obligations in FDA-Regulated Clinical Research CME/CEU Badge

Describes the commitments and obligations assumed by investigators when they conduct industry-sponsored clinical investigations under investigational new drug (IND) requirements, including the requirements of the Form FDA 1572. Discusses investigator responsibilities, including required study records and reporting requirements. An overview of the investigator's relationship with the sponsor organization as well as the investigator's commitment to the subjects, the institutional review board/independent ethics committee (IRB/IEC), and the FDA are also included.

Recommended Use: Required
ID (Language): 1356 (English), 12155 (Spanish), 16340 (Portuguese), 16033 (Korean), 13435 (Thai), 13513 (French), 16562 (Vietnamese)

Toggle Content Managing Investigational Agents According to GCP Requirements CME/CEU Badge

Describes the responsibilities of investigators when using investigational products according to GCP standards. This includes requirements for shipping and storage of investigational agents, as well as recording the receipt, use, and final disposition of investigational agents. Also reviews what constitutes investigational products and the management requirements for their use by study subjects.

Recommended Use: Required
ID (Language): 1357 (English), 12156 (Spanish), 16341 (Portuguese), 16034 (Korean), 13443 (Thai), 13512 (French), 16563 (Vietnamese)

Toggle Content Overview of U.S. FDA Regulations for Medical Devices CME/CEU Badge

Provides an overview of the FDA regulations for investigations and marketing requirements for medical devices, including investigator and IRB responsibilities. Discusses the differences between significant risk and non-significant risk devices. Reviews the characteristics and marketing requirements for Class I, II, and III devices, including premarket approval (PMA) application, 510(k) devices, exempt devices, and when an Investigational Device Exemption (IDE) is required.

Recommended Use: Required
ID (Language): 1358 (English), 12151 (Spanish), 16342 (Portuguese), 16035 (Korean), 13439 (Thai), 13511 (French), 16564 (Vietnamese)

Toggle Content Informed Consent in Clinical Trials of Drugs, Biologics, and Devices CME/CEU Badge

Discusses informed consent guidelines, the required and optional elements of informed consent, and the process for obtaining informed consent. Presents the differences between FDA and U.S. Department of Health and Human Services (HHS) regulations. Reviews challenges associated with informed consent and the concept of vulnerable subjects, stipulations for waiving the requirement for documenting or obtaining consent, and exceptions to the requirement for obtaining consent under FDA regulations.

Recommended Use: Required
ID (Language): 1359 (English), 12194 (Spanish), 16343 (Portuguese), 16036 (Korean), 13441 (Thai), 13510 (French), 16565 (Vietnamese)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Toggle Content Detecting and Evaluating Adverse Events CME/CEU Badge

Reviews the definition of adverse events (AEs) and related clinical trial terminology. Describes the process for identifying AEs in clinical research, the issues to consider in assessing the severity and causality of AEs with examples to illustrate the evaluation process. This module also contains a discussion on determining severity and causality.

Recommended Use: Required
ID (Language): 1360 (English), 12152 (Spanish), 16344 (Portuguese), 16037 (Korean), 13432 (Thai), 13667 (French), 16566 (Vietnamese)

Toggle Content Reporting Serious Adverse Events CME/CEU Badge

Defines the criteria for reporting of serious adverse events (SAEs) to regulatory agencies, IRBs, and sponsors. Includes definitions for "serious" and "unexpected" adverse events and provides categories of relatedness to the investigational agent and how they affect reporting. Reviews reporting requirements for bioavailability (BA) and bioequivalence (BE) studies, blinded studies, and clinical trials involving marketed drugs.

Recommended Use: Required
ID (Language): 1361 (English), 12158 (Spanish), 16345 (Portuguese), 16038 (Korean), 13434 (Thai), 13515 (French), 16567 (Vietnamese)

Toggle Content Monitoring of Clinical Trials by Industry Sponsors CME/CEU Badge

Describes industry research sponsors monitoring responsibilities under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application in the U.S. Describes the basic types of site visits conducted by industry sponsors, along with the basic requirements for each type of site visit. Presents the role of the investigative site during interactions with industry sponsors as well as the requirements for recordkeeping in studies regulated by the FDA and ICH E6.

Recommended Use: Required
ID (Language): 1362 (English), 12157 (Spanish), 16346 (Portuguese), 16039 (Korean), 12753 (Thai), 13517 (French), 16568 (Vietnamese)

Toggle Content Audits and Inspections of Clinical Trials CME/CEU Badge

Provides a basic understanding of the monitoring, auditing, and inspecting of clinical trials conducted according to GCP standards and FDA regulations. Describes the different entities that can inspect or audit a clinical trial, the factors that can determine whether an investigator will be audited, what the auditors and inspectors are looking for, and the results and consequences that can occur as a consequence of FDA inspection findings. Some FDA-regulated research may also involve federal funding, thereby requiring oversight by the Office for Human Research Protections (OHRP). As a result, it includes information on OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch Monitoring Program is also discussed.

Recommended Use: Required
ID (Language): 1363 (English), 12150 (Spanish), 16347 (Portuguese), 16040 (Korean), 13445 (Thai), 13506 (French), 16569 (Vietnamese)

Toggle Content Completing the CITI GCP Course

Provides learners with instructions on how to review completed modules, download or print their completion report, or complete a form to order CME or CEU credits. Also provides links to federal regulations, general device information, and other resources including Council for International Organizations of Medical Sciences (CIOMS), International Council for Harmonisation (ICH) Good Clinical Practices (E6), MedWatch (Safety Information and Adverse Event Reporting), and National Institutes of Health (NIH).

Recommended Use: Required
ID (Language): 1364 (English), 12161 (Spanish), 16348 (Portuguese), 16041 (Korean), 13444 (Thai), 13548 (French), 16570 (Vietnamese)


Additional Modules of Interest


Toggle Content Humanitarian Use Devices (HUDs)

Provides a basic overview of the U.S. Food and Drug (FDA) regulations and responsibilities regarding HUDs. It describes the HUD program and Humanitarian Device Exemption (HDE) regulatory process, and explains the applicable requirements and differences between 1) a “clinical use” of a HUD to treat or diagnose patients or 2) a “HUD investigation.” It also categorizes the FDA regulations and IRB review requirements for HUD investigations within and outside of the HDE approved indications, and identifies additional federal rules or institutional requirements that may apply to the clinical use of a HUD or HUD investigations.

Recommended Use: Supplemental
ID (Language): 16306 (English)
Author(s): Belinda Smith, MS, RD, CCRC - University of Kentucky; Kevin L. Nellis, MS, CIP - Maimonides Medical Center; Ada Sue Selwitz, MA - University of Kentucky

Toggle Content Phase I Research: Understanding Phase I Research

Defines phase I research as it relates to non-clinical and other phases of research. Identifies routine study designs used to develop the initial safety profile and achieve study objectives in phase I research. Reviews the importance of phase I research on drug development.

Recommended Use: Supplemental
ID (Language): 16873 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Schulman Associates IRB

Toggle Content Phase I Research: Protecting Phase I Subjects

Reviews U.S. Food and Drug Administration (FDA) requirements for initiation of phase I research studies following non-clinical studies. Describes IRB considerations for review of phase I research. Identifies ways in which researchers and staff involved in phase I research can apply the necessary safeguards to protect subjects including selecting a safe starting does, safeguards for standard dosing regimens, selecting appropriate subjects, facility safeguards, and the role of informed consent.

Recommended Use: Supplemental
ID (Language): 16874 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Schulman Associates IRB

Toggle Content Overview of the Clinical Trial Agreement (CTA)

Discusses the general purpose of a CTA, roles and responsibilities of parties to the CTA, and how the CTA fits into the research enterprise. It also compares and contrasts clinical trials involving drugs, biologics, and devices from a CTA perspective.

Recommended Use: Supplemental
ID (Language): 17356 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Toggle Content Understanding the Terms of the Clinical Trial Agreement (CTA)

Provides an overview of the context behind certain CTA terms and sections, types of language used for CTA sections, and some key elements of each section. It also outlines what should be addressed in the key sections of the CTA and the aim for each section.

Recommended Use: Supplemental
ID (Language): 17357 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Toggle Content Role of the Researcher and Site in Managing the Clinical Trial Agreement (CTA)

Discusses key roles of the researcher and site in managing the CTA, including initial assessment, review, and implementation. It also describes how the CTA is linked to site policies, the protocol, and the informed consent form, and identifies key sections of the CTA that could present risk to the site.

Recommended Use: Supplemental
ID (Language): 17358 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University

Toggle Content Clinical Trial Agreement (CTA) Negotiation for Researchers and Sites

Addresses strategies and preparation for CTA and study budget negotiations. It also identifies terminology and alternative wording options to ensure a fair and balanced CTA.

Recommended Use: Supplemental
ID (Language): 17359 (English)
Author(s): Dex Bilkic, HBSc, MBA - Boehringer-Ingelheim; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University