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Good Clinical Practice (GCP)

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices.

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About these Courses


Good Clinical Practice (GCP) includes four basic courses tailored to the different types of clinical research. Three of the courses also include corresponding refresher courses. CITI Program offers several GCP courses that are acceptable GCP training for the new NIH policy released on 16 September 2016.

The following GCP ICH E6 Investigator Site Training courses also meet 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 and have been updated to include the ICH E6(R2) Addendum:

Basic Courses - English with ICH E6(R2) updates, Spanish, and Portuguese

  • 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)

Refresher Courses - English with updates to include ICH E6(R2), Spanish, and Portuguese

  • GCP FDA Refresher
  • GCP ICH Refresher

GCP courses were written by multiple authors and peer-reviewed by experts.

Language Availability: English, French, Korean, Portuguese, Spanish, Thai, Vietnamese

Suggested Audiences: IRB Members, Clinical Research Coordinators, Clinical Research Organizations (CROs), Researchers, Investigators, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Sponsors, Study Coordinators


Basic Courses


CME/CEU Badge
Good Clinical Practice (GCP)

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

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CME/CEU Badge
Good Clinical Practice (GCP)

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

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CME/CEU Badge
Good Clinical Practice (GCP)

GCP for Clinical Investigations of Devices

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New/Updated Badge
Good Clinical Practice (GCP)

GCP - Social and Behavioral Research Best Practices for Clinical Research

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Refresher Courses


New/Updated Badge CME/CEU Badge
Good Clinical Practice (GCP)

GCP FDA Refresher

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New/Updated Badge CME/CEU Badge
Good Clinical Practice (GCP)

GCP ICH Refresher

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New/Updated Badge
Good Clinical Practice (GCP)

GCP Device Refresher

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FAQs


Toggle ContentIs GCP training the same as human subjects protection training?

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.

Toggle ContentDoes CITI Program offer GCP training that is compliant with the NIH policy?

On 16 September 2016, the National Institutes of Health (NIH) issued a new policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) that says NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP).

CITI Program offers GCP courses that are acceptable GCP training for the NIH policy. Four of the CITI Program’s GCP ICH E6 Investigator Site Training courses also meet 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. See the course description above for details.

Toggle ContentWho should take 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.

Toggle ContentHow do I know which GCP course I should take?

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 course is suitable for social and behavioral investigators and staff who must be trained in GCP.

Toggle ContentHow long does it take to complete a GCP course?

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.

Toggle ContentAre GCP courses mutually recognized by TransCelerate BioPharma as meeting the minimum GCP ICH criteria?

Yes, the CITI Program GCP courses are mutually recognized. See above for details. 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.”

Toggle ContentHow do I know if my GCP course will be mutually recognized by TransCelerate BioPharma and study monitors?

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). The statement identifies the GCP course’s name and information regarding mutual recognition.

For courses mutually recognized by TransCelerate BioPharma, there is a version number in the Description field on the Completion Report’s “Transcript Report.”

  • 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 will indicate that you completed version 2 on the Transcript Report (it will include the course name and which version you completed).

Toggle ContentDo the CITI Program GCP courses reflect the changes from ICH GCP E6 (R2)?

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.

Toggle ContentHow frequently should learners take GCP training?

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.

Toggle ContentWhen should I take a GCP refresher course?

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.

Toggle ContentAs an administrator setting up my organization, how should I select GCP courses for my learner groups?

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.

Toggle ContentIs this GCP course eligible for continuing medical education credits?

Yes, the following courses are eligible for CME/CEU credits:

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

Toggle ContentWhat are the advantages of CITI Program's GCP training?

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.

Toggle ContentDo social and behavioral researchers need to take GCP?

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.

Toggle ContentWill I be notified if this course is significantly revised or updated?

Yes, CITI Program will notify administrators via eBlast (email) and post announcements on our website when courses are significantly revised or updated.

Toggle ContentWho developed the GCP - Social and Behavioral Research Best Practices for Clinical Research course?

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.

Toggle ContentCan I change the passing score for the GCP - Social and Behavioral Research Best Practices for Clinical Research course?

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.

Toggle ContentHow does the GCP - Social and Behavioral Research Best Practices for Clinical Research course differ from other GCP courses?

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.

Toggle ContentCan I combine the GCP - Social and Behavioral Research Best Practices for Clinical Research course with other courses?

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