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CITI Program Good Clinical Practice (GCP) Catalog Rev. 5 June 2014

Good Clinical Practice (GCP) Series CITI Program’s GCP series consists of three basic courses, GCP for Clinical Trials with Investigational Drugs and Medical Devices – U.S. FDA Focus, GCP for Clinical Trials with Investigational Drugs and Biologics – ICH Focus, and GCP for Clinical Trials with Investigational Medical Devices. This catalog provides a listing and description of each module within the GCP courses, as well as their recommended use, continuing education (CE) eligibility, and language availability.

CITI Program Good Clinical Practice (GCP) Catalog Rev. 5 June 2014

Table of Contents Courses Basic Courses GCP FOR CLINICAL TRIALS WITH INVESTIGATIONAL DRUGS AND MEDICAL DEVICES (U.S. FDA FOCUS)………………………………………………………………..1 GCP FOR CLINICAL TRIALS WITH INVESTIGATIONAL DRUGS AND BIOLOGICS (ICH FOCUS)…………………………………………………………………………………8 GCP FOR CLINICAL TRIALS WITH INVESTIGATIONAL MEDICAL DEVICES…………………….13

CITI Program Good Clinical Practice (GCP) Catalog Page

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Basic Courses For basic courses in the GCP series, it is highly recommended that organizations present all modules in a given course as required for a learner to earn a completion report. For more information, see the Using CITI Program Content: Good Clinical Practice (GCP) document.

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) This course is intended for research personnel involved in drug, device, or biologic studies and who would benefit from FDA-‐focused training.

Continuing Education (CE) Credits and Units These modules hold the following credit designations:

• Physicians: Up to 6 AMA PRA Category 1 Credits TM • Psychologists: 6 CEP Credits • Nurses: 6 CNE Contact Hours • Other Participants: Up to 6 AMA PRA Category 1 Credits TM

Credit Designation Period:

• Physicians, Psychologists, and Other Participants: 1 July 2013 to 30 June 2016 • Nurses: 30 October 3013 to 30 October 2015

Module Title Recommended Use

The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices Required

Overview of New Drug Development Required

Overview of ICH GCP Required

ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations Required

Conducting Investigator-‐Initiated Studies According to FDA Regulations and GCP Required

Investigator Obligations in FDA-‐Regulated Clinical Research Required

Managing Investigational Agents According to GCP Requirements Required


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Overview of U.S. FDA Regulations for Medical Devices Required

Informed Consent Required

Detecting and Evaluating Adverse Events Required

Reporting Serious Adverse Events Required

Monitoring of Clinical Trials by Industry Sponsors Required

Audits and Inspections of Clinical Trials Required

Completing the CITI GCP Course Required

Humanitarian Use Devices (HUDs) Supplemental

The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices This module provides an overview of the GCP course along with links to the Belmont Report. Language Availability English (ID: 1350) Spanish (ID: 12149) Portuguese (ID: 16335) Korean (ID: 16028) Chinese (ID: 12751) Thai (ID: 13440) French (ID: 13505) Vietnamese (ID: 16558)

Overview of New Drug Development This module describes the role of industry sponsors in the conduct of clinical trials under an investigational new drug (IND) application according to FDA regulations. It provides an overview of definitions, procedures, and timelines associated with the development of a new drug. Language Availability English (ID: 1351) Spanish (ID: 12159) Portuguese (ID: 16336) Korean (ID: 16029) Chinese (ID: 12777) Thai (ID: 13433) French (ID: 13514) Vietnamese (ID: 16559) Overview of ICH GCP The purpose of this module is to provide a basic understanding of the role of the ICH guidelines and the impact on conducting clinical research according to GCP. The purpose of the ICH and the basic requirements for compliance with ICH are described, including an overview of the ICH E6 GCP guidelines. This module concludes with a discussion of when


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the ICH GCP guidelines apply and an introduction to how these differ from the FDA regulations. Language Availability English (ID: 1352) Spanish (ID: 12720) Portuguese (ID: 16337) Korean (ID: 16030) Chinese (ID: 12779) Thai (ID: 13438) French (ID: 13509) Vietnamese (ID: 16560)

ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations This module expands on the introduction presented in the ICH Overview module. The major differences between ICH guidelines and FDA regulations are presented, including critical areas such as confidentiality of medical records, signature of the person conducting the consent discussion, and impartial witnesses for illiterate subjects. This module also covers the differences between ICH GCP E6 and the FDA in terms of elements of consent. Language Availability English (ID: 1354) Spanish (ID: 12153) Portuguese (ID: 16338) Korean (ID: 16031) Chinese (ID: 13988) Thai (ID: 13442) French (ID: 13508) Khmer (ID: 16259) Vietnamese (ID: 16115)

Conducting Investigator-‐Initiated Studies According to FDA Regulations and GCP This module discusses topics important to researchers who are also the sponsors of studies and thus are conducting investigator-‐initiated studies. Topics discussed include how to determine whether an investigational new drug (IND) application or an investigational device exemption (IDE) is required, the role of the sponsor-‐investigator, documentation required for INDs and IDEs, and reports that must be submitted to the FDA for active INDs/IDEs. Language Availability English (ID: 1355) Spanish (ID: 12154) Portuguese (ID: 16339) Korean (ID: 16032) Chinese (ID: 12780) Thai (ID: 13436) French (ID: 13507) Vietnamese (ID: 16561)

Investigator Obligations in FDA-‐Regulated Clinical Research This module describes the commitments and obligations assumed by investigators when they conduct industry-‐sponsored clinical investigations under investigational new drug


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(IND) requirements, including the requirements of the FDA Form 1572, Statement of Investigator. Required study records and reporting requirements continue the discussion. 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 U.S. FDA are also included. Language Availability English (ID: 1356) Spanish (ID: 12155) Portuguese (ID: 16340) Korean (ID: 16033) Chinese (ID: 12782) Thai (ID: 13435) French (ID: 13513) Vietnamese (ID: 16562)

Managing Investigational Agents According to GCP Requirements This module focuses on specific requirements associated with the management of investigational products by investigators. This includes requirements for shipping and storage of investigational agents, as well as recording the receipt, use, and final disposition of investigational agents. This module also reviews what constitutes investigational products and the management requirements for their use by study subjects. Language Availability English (ID: 1357) Spanish (ID: 12156) Portuguese (ID: 16341) Korean (ID: 16034) Thai (ID: 13443) French (ID: 13512) Vietnamese (ID: 16563)

Overview of U.S. FDA Regulations for Medical Devices This module provides a review of the responsibilities of investigators conducting clinical research involving medical devices. It includes a discussion of the difference between significant risk and non-‐significant risk devices. The characteristics and marketing requirements for Class I, II, and III devices are reviewed. This module concludes with a review 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. Language Availability English (ID: 1358) Spanish (ID: 12151) Portuguese (ID: 16342) Korean (ID: 16035) Chinese (ID: 13925) Thai (ID: 13439) French (ID: 13511) Vietnamese (ID: 16564)


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Informed Consent This module discusses informed consent guidelines, the required and optional elements of informed consent, and the process for obtaining informed consent. There is also a discussion of the differences between FDA and U.S. Department of Health and Human Services (HHS) regulations. Some of the challenges associated with informed consent and the concept of vulnerable subjects are also reviewed. Language Availability English (ID: 1359) Spanish (ID: 12220) Portuguese (ID: 16343) Korean (ID: 16036) Chinese (ID: 13931) Thai (ID: 13441) French (ID: 13510) Vietnamese (ID: 16565)

Detecting and Evaluating Adverse Events This module reviews the definition of adverse events (AEs) and related clinical trial terminology. It 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. Reporting of AEs to the institutional review board/independent ethics committee (IRB/IEC) completes the module. Language Availability English (ID: 1360) Spanish (ID: 12152) Portuguese (ID: 16344) Korean (ID: 16037) Chinese (ID: 13930) Thai (ID: 13432) French (ID: 13667) Vietnamese (ID: 16566)

Reporting Serious Adverse Events This module discusses the criteria for reporting of serious adverse events (SAEs) to regulatory agencies, and sponsors. The discussion includes definitions for "serious" and "unexpected" adverse events and it reviews the requirements for the reporting of SAEs within time frames required by the FDA and the ICH. This module provides categories of relatedness to the investigational agent and how they affect reporting. Language Availability English (ID: 1361) Spanish (ID: 12158) Portuguese (ID: 16345) Korean (ID: 16038) Chinese (ID: 13934) Thai (ID: 13434) French (ID: 13515) Vietnamese (ID: 16567)


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Monitoring of Clinical Trials by Industry Sponsors This module describes the obligation of industry research sponsors to monitor the progress of clinical trials under an investigational new drug (IND) or investigational device exemption (IDE) application in the U.S. The types of site visits conducted by industry sponsors are described, along with the basic requirements for each type of site visit. This module describes the role of the investigative site during interactions with industry sponsors as well as the requirements for recordkeeping in studies regulated by the FDA. Language Availability English (ID: 1362) Spanish (ID: 12157) Portuguese (ID: 16346) Korean (ID: 16039) Thai (ID: 12753) French (ID: 13517) Vietnamese (ID: 16568)

Audits and Inspections of Clinical Trials This module provides a basic understanding of the monitoring, auditing, and inspecting of clinical trials conducted according to GCP standards. It 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, this module includes information on OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch Monitoring Program is also discussed. Language Availability English (ID: 1363) Spanish (ID: 12150) Portuguese (ID: 16347) Korean (ID: 16040) Chinese (ID: 13917) Thai (ID: 13444) French (ID: 13506) Vietnamese (ID: 16569)

Completing the CITI GCP Course This module summarizes the issues presented in the preceding modules. Language Availability English (ID: 1364) Spanish (ID: 12161) Portuguese (ID: 16348) Korean (ID: 16041) Chinese (ID: 13919) Thai (ID: 13445) French (ID: 13548) Vietnamese (ID: 16570)


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Humanitarian Use Devices (HUDs) This module provides a basic overview of the FDA regulations and responsibilities regarding HUDs. It describes the Humanitarian Use Device (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.” This module 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. Language Availability English (ID: 16306) Note: This module does not hold CE credit designation.


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GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) This course is intended for research personnel involved in drug and biologic studies and who would benefit from a more internationally focused training. It should be noted, however, that when appropriate, references to FDA regulations and guidance are included. This ICH E6 GCP Investigator Site Training 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. Organizations that wish to utilize this course in keeping with the minimum criteria must designate all available (ICH Focus) modules as “Required.”


• Physicians: 4 AMA PRA Category 1 Credits TM • Psychologists: 3 CEP Credits • Nurses: 4 CNE Contact Hours • Other Participants: 4 AMA PRA Category 1 Credits TM


• Physicians, Psychologists, and Other Participants: 17 October 2012 to 16 October 2015

• Nurses: 7 June 2013 to 7 June 2015


The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Biologics Required

Overview of New Drug Development Required

Overview of ICH GCP Required

ICH -‐ Comparison Between ICH GCP E6 and U.S. FDA Regulations Required

Conducting Investigator-‐Initiated Studies According to FDA Regulations and GCP Required

Investigator Obligations in FDA-‐Regulated Research Required

Managing Investigational Agents According to GCP Requirements Required

Informed Consent in Clinical Trials of Drugs and Biologics Required

Monitoring Clinical Trials of Drugs by Industry Sponsors Required

Audits and Inspections of Clinical Trials of Drugs and Biologics Required


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The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Biologics This module provides an overview of the GCP course along with links to the Belmont Report. Language Availability English (ID: 14613) Spanish (ID: 15273) Portuguese (ID: 16359) Korean (ID: 16052)

Overview of New Drug Development This module describes the role of industry sponsors in the conduct of clinical trials under an investigational new drug (IND) application according to FDA regulations. It provides an overview of definitions, procedures, and timelines involved for the development of a new drug. Language Availability English (ID: 14621) Spanish (ID: 15280) Korean (ID: 16059)

Overview of ICH GCP The purpose of this module is to provide an overview of the role of the ICH guidelines and their impact on conducting human clinical research. The purpose of and the basic requirements for compliance with the ICH are described, including an overview of the ICH E6 GCP guidelines. This module concludes with a discussion on when the ICH’s GCP guidelines apply and an introduction on how these differ from the FDA regulations. Language Availability English (ID: 14622) Spanish (ID: 15281) Portuguese (ID: 16366) Korean (ID: 16060)

ICH -‐ Comparison Between ICH GCP E6 and U.S. FDA Regulations This module expands on the introduction presented in the ICH Overview module. The major differences between ICH guidelines and FDA regulations are presented, including a discussion of specific areas such as confidentiality of medical records, signature of person conducting the consent discussion, impartial witnesses for illiterate subjects, and the elements of informed consent. Language Availability English (ID: 14625) Spanish (ID: 15282) Portuguese (ID: 16367) Korean (ID: 16061)

Detecting and Evaluating Adverse Events Required

Reporting Serious Adverse Events in Investigations of Drugs and Biologics Required



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Conducting Investigator -‐ Initiated Studies According to FDA Regulations and GCP Medical research is important and investigators strive to find novel therapies, new drugs, and modifications or new uses for existing drugs. This module introduces the requirements that must be met to conduct investigator-‐initiated trials of investigational drugs. This module provides an overview of when an investigational new drug (IND) application must be filed, the information that must be provided, and the requirements for monitoring of clinical trials. Given ICH E6 as a standard for the elements of clinical research including design, conduct, performance, monitoring, and auditing, this module provides a discussion as to the purposes of monitoring and summarizes its components. Language Availability English (ID: 14614) Spanish (ID: 15274) Portuguese (ID: 16360) Korean (ID: 16053)

Investigator Obligations in FDA-‐Regulated Research When investigators participate in an industry-‐sponsored clinical investigation, they assume certain professional and legal obligations. Investigators, therefore, must understand the study and regulatory requirements to ensure the successful outcome of a clinical investigation. This module provides an overview of investigator commitments and obligations, and it summarizes the investigator’s relationship with the industry-‐sponsor. Particular attention is focused on two aspects of the sponsor’s site assessments covered by ICH guidelines: adequate resources and medical care of trial subjects. Reporting and record-‐retention are also included, with applicable references to both FDA and ICH requirements. Language Availability English (ID: 14615) Spanish (ID: 15275) Portuguese (ID: 16361) Korean (ID: 16054)

Managing Investigational Agents According to GCP Requirements GCP standards require specific management of investigational products by principal investigators. Definitions and information related to the requirements for the use of investigational products, as defined by the FDA and ICH, are presented as a basis for this module. ICH requirements associated with investigator control continues the discussion. This module concludes with sections on shipping, storage, dispensing, and final disposition of investigational agents. Language Availability English (ID: 14617) Spanish (ID: 15276) Portuguese (ID: 16362) Korean (ID: 16055)

Informed Consent in Clinical Trials of Drugs and Biologics This module discusses the informed consent guidelines (as reflected in both FDA regulations and ICH guidelines), which set the required and additional elements of informed consent. This module also includes a discussion of the documentation of consent with


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specific discussion on the role of legally authorized representatives. Some of the challenges associated with informed consent and the concept of vulnerable subjects are also covered, including issues related to subjects who cannot consent and the exceptions to the informed consent requirements. Language Availability English (ID: 14618) Spanish (ID: 15277) Portuguese (ID: 16363) Korean (ID: 16056)

Monitoring Clinical Trials of Drugs by Industry Sponsors U.S. federal regulations and ICH guidelines require that sponsors of clinical research monitor the studies of investigational drugs to ensure that they comply with standards for the protection of human research subjects. This module 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 site record-‐keeping in studies that are regulated by the U.S. FDA and in adherence to ICH E6. Language Availability English (ID: 14619) Spanish (ID: 15279) Portuguese (ID: 16365) Korean (ID: 16057)

Audits and Inspections of Clinical Trials of Drugs and Biologics This module provides basic information on monitoring, audits, and inspections of clinical trials conducted according to standards for GCP. It 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. Language Availability English (ID: 14620) Spanish (ID: 15279) Portuguese (ID: 16365) Korean (ID: 16058)

Detecting and Evaluating Adverse Events This module provides a review of the definition of adverse events (AEs) and related clinical trial terminology in accordance with ICH guidelines. It 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. This module also includes discussion on determining AE severity and causality, and the reporting of AEs to IRBs. Language Availability English (ID: 14623)


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Spanish (ID: 15283) Portuguese (ID: 16368) Korean (ID: 16062)

Reporting Serious Adverse Events in Investigations of Drugs and Biologics This module discusses the criteria for reporting serious adverse events (SAEs) to regulatory agencies, and sponsors. The discussion, framed by both FDA regulations and ICH guidelines, includes definitions for "serious" and "unexpected" adverse events (AEs), and the time frames for the reporting of SAEs. This module provides categories of relatedness to the investigational agent and how they affect reporting. Language Availability English (ID: 14624) Spanish (ID: 15284) Portuguese (ID: 16369) Korean (ID: 16063)

Completing the CITI GCP Course This module summarizes the issues presented in its preceding modules. Language Availability English (ID: 14626) Spanish (ID: 15285) Portuguese (ID: 16370) Korean (ID: 16064)


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GCP for Clinical Trials with Investigational Medical Devices This course is intended for research personnel involved in device studies. It should be noted that, where appropriate, reference to FDA regulations and guidance is included.


• Physicians: 3 AMA PRA Category 1 Credits TM • Psychologists: 3 CEP Credits • Nurses: 3 CNE Contact Hours • Other Participants: 3 AMA PRA Category 1 Credits TM


• Physicians, Psychologists, and Other Participants: 15 February 2013 to 14 February 2016

• Nurses: 28 August 2013 – 28 August 2015


The CITI Good Clinical Practice Course for Clinical Trials Involving Investigational Medical Devices Required

Overview of U.S. FDA Regulations for Medical Devices Required

Investigator Obligations in FDA-‐Regulated Clinical Research of Devices Required

Conducting Investigator-‐Initiated Clinical Trials of Devices Required

Managing Investigational Devices According to GCP Requirements Required

Informed Consent in Clinical Trials of Devices Required

Monitoring Clinical Trials of Devices Required

Audits and Inspections of Clinical Trials of Devices Required

Reporting Requirements for Device Studies Required


Humanitarian Use Devices (HUDs) Supplemental

The CITI Good Clinical Practice Course for Clinical Trials Involving Investigational Medical Devices This module provides an overview of the GCP for Clinical Trials with Investigational Medical Devices course along with links to the Belmont Report.


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Language Availability English (ID: 14633) Spanish (ID: 15286) Portuguese (ID: 16349) Korean (ID: 16042)

Overview of U.S. FDA Regulations for Medical Devices This module reviews the responsibilities of investigators conducting clinical research involving medical devices. It includes a discussion of the difference between significant risk (SR) and non-‐significant risk (NSR) devices. The characteristics and marketing requirements for Class I, II, and III devices are reviewed. This module concludes with a review 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. Language Availability English (ID: 14637) Spanish (ID: 15290) Portuguese (ID: 16353) Korean (ID: 16046)

Investigator Obligations in FDA-‐Regulated Clinical Research of Devices Investigators assume responsibilities when participating in clinical investigations sponsored by device companies under investigational device exemption (IDE) requirements. This module describes the commitments and obligations assumed by investigators. Required study records and reporting requirements continue the discussion. 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 is also included. Language Availability English (ID: 14635) Spanish (ID: 15288) Portuguese (ID: 16351) Korean (ID: 16044)

Conducting Investigator-‐Initiated Clinical Trials of Devices This module discusses topics relevant to researchers who are also the sponsors of studies, i.e., investigator-‐initiated device studies. Topics discussed include significant risk (SR) and non-‐significant risk (NSR) device studies, sponsor-‐investigator investigational device exemptions (IDEs), and reporting requirements. Language Availability English (ID: 14634) Spanish (ID: 15287) Portuguese (ID: 16350) Korean (ID: 16043)

Managing Investigational Devices According to GCP Requirements This module focuses on specific requirements associated with the management of investigational products by principal investigators, with a specific focus on GCP standards.


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This module includes a discussion of the regulation of studies involving investigational devices, including sponsor requirements for selecting investigators, investigator control of devices, packaging and shipping, and storage of devices. Language Availability English (ID: 14636) Spanish (ID: 15289) Portuguese (ID: 16352) Korean (ID: 16045)

Informed Consent in Clinical Trials of Devices This module discusses the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. There is also a discussion of the differences between FDA and U.S. Department of Health and Human Services (HHS) regulations. Challenges associated with informed consent and the concept of vulnerable subjects is also covered. Language Availability English (ID: 14638) Spanish (ID: 15291) Portuguese (ID: 16354) Korean (ID: 16047)

Monitoring Clinical Trials of Devices This module describes the obligation of industry research sponsors to monitor the progress of clinical trials under an investigational device exemption (IDE) in the U.S. The types of site visits conducted by industry sponsors are described along with the basic requirements for each type of site visit. The role of the investigative site during interactions with industry sponsors as well as the required documentation and a review of record keeping in studies regulated by the FDA are also covered. Language Availability English (ID: 14639) Spanish (ID: 15292) Portuguese (ID: 16355) Korean (ID: 16048)

Audits and Inspections of Clinical Trials of Devices This module provides a basic understanding of monitoring, audits, and inspections of clinical trials conducted according to standards for GCP. It 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, the module includes an overview of OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch Monitoring Program is also discussed. Language Availability English (ID: 14640)


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Spanish (ID: 15293) Portuguese (ID: 16356) Korean (ID: 16049)

Reporting Requirements for Device Studies The use of investigational devices can pose significant risks to subjects, and the FDA requires reporting of certain events to ensure that all entities are adequately informed when new risks appear. This module explains the reporting requirements of 21 CFR 812, the FDA regulations for the conduct of investigational device studies. Language Availability English (ID: 14641) Spanish (ID: 15294) Portuguese (ID: 16357) Korean (ID: 16050)

Completing the CITI GCP Course This module summarizes the issues presented in its preceding modules. Language Availability English (ID: 14642) Spanish (ID: 15295) Portuguese (ID: 16358) Korean (ID: 16051)

Humanitarian Use Devices (HUDs) This module provides a basic overview of the FDA regulations and responsibilities regarding HUDs. It describes the Humanitarian Use Device (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.” This module 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. Language Availability English (ID: 16306) Note: This module does not hold CE credit designation

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