Good Clinical Practice
IMPORTANT NOTE: As of July 1, 2010, all investigators and key research personnel engaged in human subject CLINICAL TRIALS research (proposals involving drugs, devices, interventional/behavioral treatments) must complete the online Collaborative Institutional Training Initiative (CITI) program for GOOD CLINICAL PRACTICE (GCP) prior to IRB approval of a new or continuing review application.
Key research personnel are defined as the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved with the clinical trial, or handling private information (patient's medical records and charts) related to study participants during the course of a research project. Key research personnel also include faculty sponsors who provide direct oversight of research with study participants or research using study participant's private information.
How do I Register as a New User?
Proceed to www.citiprogram.org and click on the “New Users Register Here” link.
- Select “Drexel University College of Medicine” as your Participating Institution from a pull-down menu. You are not required to affiliate with any other institution. You will then answer questions 2-7 on this web page.
- Next, you will also be asked for contact and demographics information.
- On the “Getting Started” page you will be asked to select the desired/required courses; you are given the opportunity to select from Human Subjects Research, HIPS, Good Clinical Practice and Responsible Conduct of Research. (If needed you may select additional courses such as GCP at this time).
- You will then be asked to select your Learner Group for each training module selected. Choose the Learner Group that best fits the type of research in which you are most often engaged. If your protocol requires you to complete the GCP training, then more likely than not you are a member of Learner Group 1.
- The Learning Groups are:
Group 1: Key research personnel conducting Medical, Biomedical, Nursing, Public Health and Psychology Research Investigations Group 2: Key research personnel conducting Social, Behavioral and Educational Research Investigations
Group 3: IRB Members and ORRC Staff, - CITI based HIPAA training, called HIPS, is required for personnel in Learner Groups 1 & 3. You will select the HIPS training program based upon your specific Learner Group.
- If you have already indicated you will be taking the GCP or RCR programs you will again be asked to indicate your Learner Group (if you did not sign up for either GCP or RCR these pages will not appear).
How can I add GCP training to my CITI profile if I have already registered?
You may add the GCP training course from your CITI home page by clicking on the link titled “Add a Course or Update Your Learner Group”. Once you click on the link you will be prompted to indicate the course you would like to add. Once you have done this you will follow the online directions to complete registration.
How many modules are required to complete GCP training?
GCP training requires completion of the 15 modules noted below. You must complete and pass by gaining an 80% average on the module quizzes from your Learner Group.
How long does GCP training take to complete?
Most users complete all of their required modules in 6-8 hours. You are not required to complete the training all at one sitting.
Can I stop and start again later?
Yes, you can stop and begin at anytime. However, if you are in the middle of a module and taking an exam you must complete the exam before stopping, otherwise your exam results will not be recorded.
What if I am transferring my training from another institution?
If an investigator has taken CITI training elsewhere, the previously completed training will be accepted at Drexel, with the caveat that key research personnel complete any CITI courses required by Drexel that have not already been completed. For personnel whose prior training has expired they would recertify in the same manner as DU/DUCoM personnel. If you are having trouble locating your prior training records please see the CITI Support Center for assistance.
What about collaborators at other sites?
DU/DUCoM specific training programs would only be required for collaborators for whom Drexel has agreed to act as the IRB of record. If unaffiliated collaborators have received their own IRB approval, they do not need to undergo the Drexel training and should defer to their own IRB's training requirements.
Collaborators as co-investigators, key personnel or students from an outside institution who wish to conduct clinical trials research at DU/DUCoM must register and complete the appropriate DU/DUCoM training modules according to their Learner Group and type of research conducted. During registration, if you do not have a Drexelmed.edu or Drexel.edu email address, you may complete your registration with a personal email address of your own choosing. The unaffiliated personnel must “affiliate” with Drexel University College of Medicine during the CITI registration process in order to view and complete the required DUCoM specific modules.
How do I obtain a certificate of completion?
After you have finished the required modules you will be issued a completion report that is available to print from your learner menu. Please print the report and keep a copy for your records. Please also give a copy to any members of your administrative team who need it for their records. For help printing the report please visit the CITI site. ORRC will be able to confirm that you have taken the training by looking online, however but ORRC will not be able to print off your certificate for you.
How often is GCP recertification training required?
Investigators and key personnel will be required to refresh their training every three (3) years. This can be accomplished by retaking the 15 GCP modules as offered by CITI. You should receive an automatic reminder from CITI approximately 90 days prior to your anniversary date.
What do I do if I forget my password?
If you forget your password please follow the instructions on the CITI website.
CME Credits
Continuing Medical Education credits may be offered by the University of Miami with respect to the CITI program. Questions regarding CME should be directed to the CITI help desk.
Who can I talk to if I have questions?
For questions regarding GCP training and incorporating GCP procedures within your department, please contact Marcellina Oparaoji at 215-255-7807, or by email at Marcellina.Oparaoji@DrexelMed.edu.
The CITI Support Center also provides resources, hints, tips and answers to frequently asked questions about the CITI Program.
For questions regarding this guidance document or Institutional Review Board guidance and research compliance please contact Jack Medendorp or Marina Bounds at 215-255-7857.
Access to informative and appropriate training programs assists the investigative team in performance and conduct of research in a compliant format. The training programs offered at DUCOM/DU provide guidance and direction to aid you on your path to success.