GCP for Clinical Trials with Investigational Drugs and Biologics (ICH 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): 14613 (English), 16052 (Korean), 19605 (Chinese), 15273 (Spanish)

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): 14621 (English), 16059 (Korean), 19606 (Chinese), 15280 (Spanish)

Describes the purpose of the ICH, the relationship between the GCP principles and Annex 1 in ICH E6(R3), the key principles and benefits of data governance in clinical trials as outlined in ICH E6(R3), the basic requirements for compliance with ICH E6(R3), and how the ICH E6(R3) guideline fits with U.S. federal regulations regarding clinical research.

Recommended Use: Required
ID (Language): 14622 (English), 16030 (Korean), 19607 (Chinese), 15281 (Spanish)

Explains the legal status of the ICH guidelines in the U.S., how investigators determine whether to adhere to the ICH guidelines, and important differences between the ICH guidelines and U.S. FDA regulations.

Recommended Use: Required
ID (Language): 14625 (English), 16061 (Korean), 19608 (Chinese), 15282 (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): 14614 (English), 16053 (Korean), 19609 (Chinese), 15274 (Spanish)

Discusses the commitments and obligations that investigators assume when participating in clinical investigations; the investigator's relationship with the sponsor organization; and the investigator's commitments to the study participants, the Institutional Review Board (IRB), and the regulatory authorities.Describes the commitments and obligations assumed by investigators when they conduct industry-sponsored clinical investigations under ICH E6 and investigational new drug (IND) requirements, including the requirements of the Form FDA 1572. Discusses investigator responsibilities including conduct of the study, reporting requirements, required study records, and communicating with the IRB, federal agencies, and sponsor.

Recommended Use: Required
ID (Language): 14615 (English), 16054 (Korean), 19610 (Chinese), 15275 (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 participants.

Recommended Use: Required
ID (Language): 14617 (English), 16055 (Korean), 15276 (Spanish), 19611 (Chinese)

Discusses informed consent requirements as reflected in both FDA regulations and ICH guidelines, including obtaining and documenting consent. Includes a discussion of the documentation of consent with specific discussion on the role of legally authorized representatives. Covers challenges associated with informed consent and the concept of vulnerable subjects, including issues related to subjects who cannot consent and the exceptions to the informed consent requirements.

Recommended Use: Required
ID (Language): 14618 (English), 16056 (Korean), 19612 (Chinese), 15277 (Spanish)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Describes the obligation of industry sponsors to monitor the progress of clinical trials under an investigational new drug (IND) application as well as the requirements for recordkeeping in studies that are regulated by the FDA and in adherence to ICH E6(R3). Identifies the types of site visits conducted by sponsors, the basic requirements for each type of site visit, and the role of the investigative site during interactions with industry sponsors.

Recommended Use: Required
ID (Language): 14619 (English), 16057 (Korean), 19613 (Chinese), 15278 (Spanish)

Provides basic information on monitoring, audits, and inspections of clinical trials conducted according to the ICH E6(R3) standards for GCP. 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 result of FDA inspection findings. Regulatory documents reviewed during inspections are presented and referenced to FDA and ICH GCP requirements. 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): 14620 (English), 16058 (Korean), 19614 (Chinese), 15279 (Spanish)

Defines adverse events (AEs) and related clinical trial terminology in accordance with ICH guidelines. Describes the process for identifying AEs in clinical research and identifies the factors to consider in assessing the severity and causality of AEs. Examples are provided to illustrate the evaluation process. Includes discussion on determining AE severity and causality, and the reporting of AEs to IRBs.

Recommended Use: Required
ID (Language): 14623 (English), 16062 (Korean), 19615 (Chinese), 15283 (Spanish)

Identifies the criteria for investigators reporting serious adverse events (SAEs) to regulatory agencies and sponsors. Defines adverse events (AEs) and suspected adverse reactions and explains how AEs are classified as “life-threatening,” “serious,” or “unexpected” events. Reviews sponsor monitoring and reporting requirements of AEs. Discusses reporting safety information for bioavailability (BA) and bioequivalence (BE) studies, clinical trials involving marketed drugs, and blinded studies.

Recommended Use: Required
ID (Language): 14624 (English), 16063 (Korean), 19616 (Chinese), 15284 (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.

Recommended Use: Required
ID (Language): 14626 (English), 16064 (Korean), 15285 (Spanish), 19617 (Chinese)

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, CIP - CITI Program