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GCP Training

GCP Training Requirements

Research team personnel participating in the following types of studies must complete GCP training:

- Studies involving INDs - Investigational New Drugs

- Studies involving SR (Significant Risk) Device IDEs - Investigational Device Exemption

- Studies involving NSR (Non Significant Risk) Devices

- Studies meeting the NIH Definition of Clinical Trial

UTA utilizes online training offered by CITI and NIH.  There are two training pathways available, one focused on Biomedical Research, and another focused on Behavioral/Social Science Research.  Please select and complete the training package applicable to your study.  If you need assistance in determining the appropriate training package, please contact Regulatory Services.

Instructions for Biomedical GCP Training

1. Visit https://www.citiprogram.org/ and click “Register"

a. If you already have a CITI account through another institution, you must add an affiliation with The University of Texas at Arlington to be able to access the courses.  Instructions for adding an affiliation are available here: https://support.citiprogram.org/customer/en/portal/articles/163336-how-to-add-change-your-affiliated-institution-or-transfer-completions- 

2. During registration, select your curriculum:

a. In "Question 1 Human Subject Research" select the option "Biomedical Research Investigators"

b. In "Question 2 Institiutional Official/IRB Chair" do not select an option (leave blank)

c. In "Question 3 Good Clinical Practice" select the option "Good Clinical Practice Course, US FDA Focus"

3. Open the course "Biomedical Research" and complete the following module:

a. FDA-Regulated Research (ID: 12)

4. Open the course "GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)" and complete the following modules:

a. Overview of ICH GCP (ID: 1352)

b. Conducting Investigator Initiated Studies According to FDA Regulations and GCP (ID: 1355)

c. Investigator Obligations in FDA-Regulated Research (ID: 1356)

d. Managing Investigational Agents According to GCP Requirements (ID: 1357)

e. Detecting and Evaluating Adverse Events (ID 1360)

f. Reporting Serious Adverse Events (ID: 1361)

g. Audits and Inspections of Clinical Trials (ID 1363)

h. Extra module for studies involving IDEs (SR or NSR devices): Overview of U.S. FDA Regulations for Medical Devices (ID: 1358)

i. The remaining modules are recommended, but optional. 

Instructions for Behavioral/Social Science GCP Training

The Society of Behavioral Medicine offers free training and certification of CGP, and the modules are adapted to social/behavioral research. 

1. Visit www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course 

2. Click the option for Non-Members, "Create a login." An account Setup will be emailed to you to complete the login process.

3. Click on the course "Good Clinical Practice (GCP) for Social and Behavioral Research - eLearning Course"

4. Complete the nine video modules.

5. Upon completion, save a copy of your certificate to provide to NIH and/or the IRB upon request.

Training Frequency

In accordance with NIH's Policy, research personnel on NIH-funded clinical trials must renew GCP training every 3 years.