Good Clinical Practice (GCP)

No. GCP training is a separate training and is not basic human subjects protection training. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

The National Institutes of Health (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 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.

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.

See the course descriptions above for more information on individual courses. These articles identify courses that comply with the NIH GCP Policy and answer FAQs for NIH Policy on GCP training.

GCP content is suitable for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.

Learners should take the GCP course that best meets the type of research they conduct:

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP ICH Refresher are suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum.
• GCP for Clinical Investigations of Devices and GCP Device Refresher are most appropriate for organizations or individuals who desire a more international-focused GCP curriculum and a more device-focused program. These device courses cover FDA regulation as well as International Organization for Standardization Guidelines ISO 14155:2011.
• GCP - Social and Behavioral Research Best Practices for Clinical Research and GCP SBR Advanced Refresher are suitable for social and behavioral investigators and staff who must be trained in GCP.

GCP courses vary on the number of modules they contain. Modules consist of detailed content, images, supplemental materials (such as case studies), and a quiz. Learners may complete the modules at their own pace. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around three to six hours to complete a GCP course.

There is no uniform standard regarding how frequently GCP training should occur. However, most organizations select a three-year period of retraining. The organization could request that the designated refresher course or the same basic course be presented to learners again within a given period.

Yes, five of CITI Program's GCP courses are mutually recognized. See the individual course pages for more information on TransCelerate mutual recognition, including requirements (such as module requirements) for organizations and learners to utilize the mutually recognized courses. The Support article List of TransCelerate Mutually Recognized GCP Training includes each mutually recognized course and the required modules.

Please also note that organizations and learners that wish to utilize these mutually recognized GCP courses in keeping with the minimum criteria must designate all available modules as “Required.”

Learners who fulfill a GCP course’s requirements (complete all the required modules after the effective date) will see a statement in the Description field on their Completion Report’s “Transcript Report” (part 2 of a Completion Report) or on their Certificate. The statement identifies the GCP course’s name and information regarding mutual recognition.

• Version 1 refers to the ICH E6(R1) minimum criteria that was used to attest the course for mutual recognition to TransCelerate BioPharma.

• Version 2 refers to the ICH E6(R2) revisions to the TransCelerate BioPharma’s minimum criteria for mutual recognition. CITI Program has updated all TransCelerate attested GCP courses to meet the version 2 minimum criteria. If you complete your GCP course after the effective date for version 2, your Completion Report will indicate that on the Transcript Report (it will include the course name and which version you completed).

If you completed your GCP course before version 2 was available (or before the effective date for version 2), you can return to the course and re-take the modules. After you complete all the required modules, your Completion Report and Certificate will indicate that you completed version 2.

The following Support articles provide additional information:

• CITI Program Guide to GCP Mutual Recognition
• Guide to GCP Mutual Recognition Completion Documentation
• List of TransCelerate Mutually Recognized GCP Training
• Reading and Understanding a CITI Program Completion Report and Certificate for Good Clinical Practice (GCP) TransCelerate BioPharma Mutually Recognized Training

No, you should not submit or self-attest a course to TransCelerate BioPharma. CITI Program submits and self-attests on behalf of our GCP courses.

We ensure that our mutually recognized GCP courses satisfy the requirements for mutual recognition and that completion documentation reflect the course name, version number, and all required elements (including TransCelerate information) if a learner completes a mutually recognized course.

Yes, after the ICH Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) was adopted on 15 December 2016, the CITI Program modules were revised to reflect the current guideline. The GCP courses that reference ICH E6 specifically refer to the current guideline.

CITI Program also offers some additional resources on ICH E6(R2).

• An additional module of interest titled “Overview of ICH GCP E6(R2) Revisions” can be added to GCP courses. This module 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.

• A free resource that provides an overview of the ICH E6(R2) integrated addendum is available on CITI Program’s Resources page. This resource covers the revisions to the International Council for Harmonistion (ICH) “Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2),” including a breakdown by section with summaries and analysis. The revised ICH E6(R2) guideline includes changes that affect sponsors, researchers, and IRBs.

Yes, the CITI Program modules were updated in December 2020 and reflect ISO 14155:2020.

Additionally, the GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course and the GCP Device Refresher course both include specific content on ISO 14155.

A refresher course provides retraining. Using CITI Program refresher course options to provide retraining means that the learner will not be completing the same course every time.

GCP refresher courses are meant to reinforce the importance of concepts covered in the basic level GCP course. The CITI Program recommends that learners complete the basic level GCP course first, and then take a refresher GCP course at the interval designated by their organization.

CITI Program allows organizations to customize their learner groups, which means they can choose the modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs.

For basic GCP courses, it is highly recommended that organizations present all modules in a given course as required for a learner to earn a completion report. Some organizations will make several modules supplemental, particularly when they provide organization-specific training on the topic.

Yes, the following courses are eligible for CME credits:

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Course
• GCP FDA Refresher Course
• GCP ICH Refresher Course
• GCP for Clinical Investigations of Devices Course
• GCP – Social and Behavioral Research Best Practices for Clinical Research

Click on the course name above for details. For more information on how to ensure CME credit availability for learners at your organization, contact support@citiprogram.org or 888.529.5929.

GCP provides research-specific, peer-reviewed training written by GCP experts. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for GCP training.

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of research that meets the definition of a clinical trial should be trained in GCP.  A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Yes, CITI Program will notify administrators via email and post news articles on our website when courses are significantly revised or updated.

The development of the GCP - Social and Behavioral Research Best Practices for Clinical Research course was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards (CTSA) Program, grant number 3UL1TR000433.

The creators of this course have set the passing score at 100 percent and organizations are not able to change or customize the passing score for this course.

The GCP - Social and Behavioral Research Best Practices for Clinical Research course applies GCP principles to behavioral intervention and social science research studies. Other GCP courses cover drug, device, and biologic-related studies.

It is recommend that the course not be combined with other courses.