GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

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

Interested? Demo Course
Scroll Down Arrow


About this Course

The GCP ICH Basic course covers the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice (GCP) guideline’s essential topics for clinical trials with drugs and biologics. It describes the responsibilities and expectations for conducting, monitoring, reporting, and documenting clinical trials.

It is intended for research personnel involved in drug and biologic studies and who would benefit from a more internationally focused training, or for researchers involved in studies where compliance with ICH E6(R3) is required (for example, most industry-funded studies). It should be noted, however, that when appropriate, references to U.S. Food and Drug Administration (FDA) regulations and guidance are included.

The course covers key topics in clinical research including:

  • Reviewing ICH GCP standards
  • Identifying investigator and sponsor obligations
  • Discussing new drug development
  • Comparing the ICH GCP E6(R3) guideline and FDA regulations
  • Describing how to detect and report adverse events
  • Auditing and monitoring expectations

This course (English and Spanish 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.

CITI Program GCP training is used by over 1,500 institutions – (including many leading hospitals, academic medical centers, universities, and healthcare companies) – to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.

View Series Page for FAQs


* 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) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.


Language Availability: Chinese, English, Korean, Spanish

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

Organizational Subscription Price: Included with Good Clinical Practice series, available as part of an organizational subscription package or for $1,000 per year/per site for government and non-profit organizations; $1,200 per year/per site for for-profit organizations
Independent Learner Price: $129 per person


Course Content

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

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)

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

Overview of ICH GCP CME/CEU Badge

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)

ICH - Comparison Between ICH GCP E6 and U.S. FDA Regulations CME/CEU Badge

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.

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): 14614 (English), 16053 (Korean), 19609 (Chinese), 15274 (Spanish)

Investigator Obligations in FDA-Regulated Research CME/CEU Badge

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)

Managing Investigational Products 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 participants.

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

Informed Consent in Clinical Trials of Drugs and Biologics CME/CEU Badge

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

Monitoring Clinical Trials of Drugs by Industry Sponsors CME/CEU Badge

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)

Audits and Inspections of Clinical Trials of Drugs and Biologics CME/CEU Badge

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)

Detecting and Evaluating Adverse Events CME/CEU Badge

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)

Reporting Serious Adverse Events in Investigations of Drugs and Biologics CME/CEU Badge

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)

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.

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


Additional Modules of Interest

Hot Topics in Clinical Research

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


CME/CEU Credits

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. Learn more about CE/CME Credits.

Physicians
AMA PRA Category 1 Credit
4 Credits
(7 CE certified modules)
$70

6 Credits
(10 CE certified modules)
$90
June 1, 2024
May 31, 2027
Psychologists
CEP Credit/Hour
4 Credits
(7 CE certified modules)
$70

6 Credits
(10 CE certified modules)
$90
June 1, 2024
May 31, 2027
Pharmacists
CPE Contact Hour
4 Credits
(7 CE certified modules)
$70

6 Credits
(10 CE certified modules)
$90
June 1, 2024
May 31, 2027
Dentists
ADA CERP Credit
4 Credits
(7 CE certified modules)
$70

6 Credits
(10 CE certified modules)
$90
June 1, 2024
May 31, 2027
Optometrists
COPE CE Credit
4 Credits
(7 CE certified modules)
$70

6 Credits
(10 CE certified modules)
$90
June 1, 2024
May 31, 2027
Nurses
Nursing Contact Hour
4 Credits
(7 CE certified modules)
$60

6 Credits
(10 CE certified modules)
$80
June 1, 2024
May 31, 2027
Dietitians
CDR CPEU
4 Credits
(7 CE certified modules)
$60

6 Credits
(10 CE certified modules)
$80
June 1, 2024
May 31, 2027
Social Workers
Ethics CE Credit
4 Credits
(7 CE certified modules)
$60

6 Credits
(10 CE certified modules)
$80
June 1, 2024
May 31, 2027
Athletic Trainers
Category A hour/CEU
4 Credits
(7 CE certified modules)
$60

6 Credits
(10 CE certified modules)
$80
June 1, 2024
May 31, 2027
Other Participants
Certificate of Participation
4 Credits
(7 CE certified modules)
$60

6 Credits
(10 CE certified modules)
$80
June 1, 2024
May 31, 2027


Learn More

Your Name(Required)
I'd Like To Receive Emails From CITI Program
This field is for validation purposes and should be left unchanged.