GCP for Clinical Investigations of Devices

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): 14633 (English), 16042 (Korean), 19766 (Finnish), 19776 (French), 19796 (German), 19786 (Chinese)

Reviews the responsibilities of investigators conducting clinical research involving medical devices. Discusses the differences between significant risk (SR) and non-significant risk (NSR) devices. Reviews the characteristics and marketing requirements for Class I, II, and III devices. Provides an overview of investigator and institutional review board/independent ethics committee (IRB/IEC) responsibilities associated with clinical trials of medical devices and a discussion of the different options associated with early access to investigational devices in advance of FDA approval.

Recommended Use: Required
ID (Language): 14637 (English), 16046 (Korean), 19767 (Finnish), 19777 (French), 19797 (German), 19787 (Chinese), 15290 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Describes the commitments and obligations assumed by investigators when conducting clinical investigations of devices, including investigator agreement, financial disclosures, and IRB submission and approval of research. Identifies required study records and reporting requirements. Reviews 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), the International Organization for Standardization (ISO), and the FDA.

Recommended Use: Required
ID (Language): 14635 (English), 16044 (Korean), 19768 (Finnish), 19778 (French), 19798 (German), 19788 (Chinese), 15288 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Highlights the requirements for conducting investigator-initiated trials of devices (investigator-initiated device studies). Describes the role of the sponsor-investigator. Discusses significant risk (SR) and non-significant risk (NSR) device studies, sponsor-investigator investigational device exemptions (IDEs), and reporting requirements.

Recommended Use: Required
ID (Language): 14634 (English), 16043 (Korean), 19769 (Finnish), 19779 (French), 19799 (German), 19789 (Chinese), 15287 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Focuses on specific requirements associated with the management of investigational products by principal investigators, with a specific focus on GCP standards and ISO 14155. Discusses requirements for investigational devices, including sponsor requirements for selecting investigators, investigator control of devices, packaging and shipping, and storage of devices.

Recommended Use: Required
ID (Language): 14636 (English), 16045 (Korean), 19770 (Finnish), 19780 (French), 19800 (German), 19790 (Chinese), 15289 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Provides an overview of the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. Identifies challenges associated with informed consent and the concept of vulnerable subjects. Describes the exceptions to the requirement for obtaining informed consent under FDA regulations and ISO 14155.

Recommended Use: Required
ID (Language): 14638 (English), 16047 (Korean), 19771 (Finnish), 19781 (French), 19801 (German), 19791 (Chinese), 15291 (Spanish)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Describes the obligation of industry research sponsors to monitor the progress of clinical trials under an investigational device exemption (IDE) in the U.S. Describes types of site visits conducted by industry sponsors along with the basic requirements for each type of site visit. Reviews the role of the investigative site during interactions with industry sponsors as well as the required documentation and record keeping in studies regulated by the FDA.

Recommended Use: Required
ID (Language): 14639 (English), 16048 (Korean), 19772 (Finnish), 19782 (French), 19802 (German), 19792 (Chinese), 15292 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Summarizes monitoring, audits, and inspections of clinical trials conducted according to 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 stem from FDA inspection findings. Because some FDA-regulated research may involve federal funds there may also be Office for Human Research Protections (OHRP) oversight. As a result, it includes an overview of OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch Monitoring Program is also discussed.

Recommended Use: Required
ID (Language): 14640 (English), 16049 (Korean), 15293 (Spanish), 19773 (Finnish), 19783 (French), 19803 (German), 19793 (Chinese)
Author(s): Daniel Redline, BA - Gilead Sciences

Explains the reporting requirements of 21 CFR 812, the FDA regulations for the conduct of investigational device studies and ISO 14155. Defines the various categories of events that must be reported for U.S. and international studies. Describes the steps sponsors must take to determine whether or not an event or an aggregate of events must be reported to the FDA or other regulatory authorities.

Recommended Use: Required
ID (Language): 14641 (English), 16050 (Korean), 19774 (Finnish), 19784 (French), 19804 (German), 19794 (Chinese), 15294 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

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): 14642 (English), 16051 (Korean), 19775 (Finnish), 19785 (French), 19805 (German), 19795 (Chinese), 15295 (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

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