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

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), 16028 (Korean)

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), 16029 (Korean), 12159 (Spanish)

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), 16030 (Korean), 12720 (Spanish)

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), 16031 (Korean), 12153 (Spanish)
Author(s): David G. Forster, JD, MA, CIP - Western IRB; Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group, Inc.

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), 16032 (Korean), 12154 (Spanish)

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), 16033 (Korean), 12155 (Spanish)

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), 16034 (Korean), 12156 (Spanish)

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), 16035 (Korean), 12151 (Spanish)

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), 16036 (Korean), 12194 (Spanish)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

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), 16037 (Korean), 12152 (Spanish)

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), 16038 (Korean), 12158 (Spanish)

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), 16039 (Korean), 12157 (Spanish)

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), 16040 (Korean), 12150 (Spanish)

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), 16041 (Korean), 12161 (Spanish)

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.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

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

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.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

Recommended Use: Supplemental
ID (Language): 16873 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research

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 dose, safeguards for standard dosing regimens, selecting appropriate subjects, facility safeguards, and the role of informed consent.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

Recommended Use: Supplemental
ID (Language): 16874 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research

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.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

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

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.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

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

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.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

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

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.

Note: This module is part of the CITI Program’s Human Subjects Research (HSR) series, but is recommended as part of this course. For organizations with a “Make Your Own” custom subscription, use of this module requires adding Human Subjects Research (HSR) to your organization’s subscription.

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

Provides an update on regulatory issues, new policies, and hot topics in clinical research. The module is revised throughout the year as needed.

Recommended Use: Supplemental
ID (Language): 19264 (English)
Author(s): Margaret Rankovic, MEd - CITI Program

Reviews the additions that led to the publication of the ICH E6(R2) guideline and discusses the new approaches for the management of clinical trials – including quality management, risk-based monitoring, and data integrity.

Recommended Use: Supplemental
ID (Language): 19277 (English)
Author(s): Margaret Rankovic, MEd - CITI Program