How Do I Access the CITI GCP Course?
Instructions to access the online CITI GCP course are provided below:
- Go to the CITI homepage: http://www.citiprogram.org
- Login (using your CITI username and password) or create a new account.
- If this is your first time using CITI select GCP as the “educational program” to complete.
- If you previously used CITI click on the "Add a course or update your learner groups" link, follow prompts, and select GCP as your “educational program”.
- From the main menu, click on the "Incomplete - Re-enter" hyperlink to begin the course.
- If you need assistance logging in, contact the CITI helpdesk: (213) 821-5272 or citi@usc.edu
What is GCP?
Good Clinical Practice (GCP) is the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides regulators assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial subjects are protected.
Additionally, Food and Drug Administration (FDA) regulations (effective October 27, 2008) require that non-IND foreign clinical studies, that support an IND or application for marketing approval for a drug or biological product, be conducted in accordance with ICH GCP. Previously these studies had to be conducted in accordance with ethical principles stated in the 1989 version of the Declaration of Helsinki version issued by the World Medical Association (WMA).
What Date Will GCP Training at USC become Mandatory and Who Needs to Complete It?
By January 1, 2010 GCP training is required for all USC PIs and Key Personnel conducting Full
Board clinical trial research. A study will NOT be approved until the training requirement is met. See GCP Mandate Memo.
Why do I have to take GCP training?
GCP training is required by most sponsors of pharmaceutical research and is required for all clinical researchers at most US academic medical centers.
What is the International Conference on Harmonisation (ICH)?
The International Conference on Harmonisation (ICH) / WHO Good Clinical Practice (GCP) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry to achieve greater harmonisation both in technical guidelines and in requirements for pharmaceutical data acquisition to reduce or obviate the need for duplicate testing.
The objective of such harmonisation is more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
Is GCP Training Available at USC?
USC provides a GCP online training program on the CITI (Collaborative Institutional Training Initiative) training site.
What are Clinical Trials (also known as Clinical Research or Medical Research)?
A Clinical Trial is a phased biomedical research study using human volunteers, designed to answer safety and efficacy questions about biologicals, devices, pharmaceuticals, new therapies or new ways of using known treatments. Clinical trials are the fastest and safest way to find efficacious treatments for those who need the remedy. Trials are often conducted in stages to obtain useful and required information by testing in a small group initially but expanding greatly once safety and efficacy are demonstrated. Most clinical trials are FDA regulated but there are exceptions. This USC GCP training requirement includes both FDA regulated and non-regulated clinical research.
Is GCP Required for Exempt or Expedited Studies?
No, GCP training is not required for studies determined to be Exempt or Expedited. Only full board clinical trial research requires GCP training.
Who are “key personnel”?
“Key Personnel” are individuals responsible for protocol development, design, conduct, or reporting of research. Principal Investigators (PIs), Co-PIs, faculty advisors, study coordinators, recruitment staff, and anyone else performing study procedures or interventions are considered key personnel. If you are unsure whether you or someone on your study team needs to take GCP, please contact the OPRS at (213) 821-1154 or oprs@usc.edu or the HSIRB at irb@usc.edu or (323) 223-2340.
How long will it take to complete the GCP course?
The average learner spends approximately 4.5 hrs and uses approximately 5 logins to complete the course. Each GCP module has text to read and a quiz to complete.
How Often Do I Need to Complete GCP Training?
PIs and Key Personnel need to complete GCP training ONCE.
Will Alternative GCP Courses Satisfy the Requirement?
Yes, alternative/equivalent GCP courses will satisfy the GCP requirement. These completion certificates must be uploaded into your iStar account.
How Do I Upload an Alternative GCP Completion Certificate into iStar?
Please email a copy or your certificate to citi@usc.edu for record keeping. The certificate will be automatically uploaded into iStar at a later date.
Do I need to take GCP if I already completed Human Subjects, HIPAA, or Contracts Management training?
Yes, you must complete GCP training even if you completed Human Subjects, HIPAA, and the Contracts Management training. GCP covers areas that these other training programs do not.
I need to complete GCP training and the human subjects "refresher" course, must I take both?
No, Investigators/key personnel that complete GCP training DON’T need to complete the human subjects "refresher course" (course offered in CITI after initial three year certificate expires). The GCP course will fulfill the "refresher" human subjects training requirement for three years from the date it is completed. However, the human subjects “refresher course” does not fulfill the GCP training requirement. GCP training is a one time requirement while human subjects education is required every three years.
Can I Receive CME Credits for Completing the GCP Training?
The CITI GCP course provides the opportunity to receive CME credits for a small fee (CITI CME Credits). The live classroom sessions at USC will also provide the opportunity to receive CME credits.
Questions or comments
USC CITI Help Desk
(213)-821-5272
citi@usc.edu