Instructions for Completing Good Clinical Practices Training

The University requires that NIH-funded investigators and staff complete Good Clinical Practice (GCP) Training every three (3) years through the Collaborative Institutional Training Initiative (CITI) Program. This is to comply with the NIH Policy, effective as of January 1, 2017.

Clinical Trial: 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.

Investigator:  The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Clinical trial staff:  Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

The below instructions apply to investigators and research staff who are involved in the conduct, oversight, or management of NIH-funded clinical trials.

Before beginning the training, be sure to read all of the steps.

Access the CITI website through The University of Texas at Austin portal: https://utdirect.utexas.edu/citi/citi_login.WBX

GCP Training Step 1

Note: If this is the first time you have visited the CITI website via the University of Texas at Austin login portal, you should select “I am a new visitor to CITI.”

Otherwise, select the option “I am a returning visitor to CITI.” If you get an error message, simply use your browser’s back button and select the returning visitor option.

You will now be directed to the CITI Main Menu. Click on the “University of Texas at Austin Courses” bar to expand it.

GCP Training Step 2

On the expanded bar, follow the link to “Add a course.”

GCP Training Step 3

On the “Select Curriculum – University of Texas at Austin” webpage choose “GCP Good Clinical Practice course” and then “Next.”

GCP Training Step 4

You will now be redirected back to the CITI Main Menu. Select the blue bar for “University of Texas at Austin Courses.” This will show the course that you have selected.

Select “GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)” to view the required modules that you must complete in order to receive completion credit for the University of Texas at Austin.

GCP Training Step 5

Follow the link “Complete the Integrity Assurance Statement” before beginning the course.

GCP Training Step 6

Read over the CITI Terms of Services, check the box at the bottom of the screen to accept them, and then click the “Submit” button.

GCP Training Step 7

You’ll then return to the “GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)” course page. The first module should now be listed in blue. Select the module to begin the course.

GCP Training Step 8

To receive credit you must complete all of the required modules with an average quiz score of at least 80. If you do not pass a quiz you can retake it an unlimited number of times. Note that quiz questions and the order of questions do change. Completion of all the modules will take approximately 4 hours. You can stop modules and resume them at a later time without penalty.

The supplemental modules are offered for researchers who wish to learn more about specific topics and do not count towards passing the course or the overall score.

Questions? Contact the Office of Research Support and Compliance at orsc@uts.cc.utexas.edu or 512-471-8871.