Go to www.citiprogram.org to begin your registration process or click here for detailed instructions.

When you have completed the selected modules, print a hard copy of the completed Grade Book for your own records.  It is not necessary to forward your completed course information to the City of Hope CRTO or IRB.  Once you have successfully completed the training course, CITI will notify the CRTO directly.

Yes. Once you create a profile you can access the program from any computer.

This will depend on your experience with human subject research. Individuals familiar with these topics may require three hours or less to complete all of the required training. However, on average the Basic Course will require 4-6 hours to complete. You do not have to complete all the training at once. The online program is designed for you to work at your own pace, and allows you to exit and return at a later date to where you left off.

After creating your CITI account, and if you were previously certified to participate in human subject research at City of Hope, select the option “I was previously certified to conduct human subject research at City of Hope” when selecting your curriculum.  You will then be asked questions that will place you appropriately into your “task specific” Learner Group which will guide you to the recertification curriculum.

Current and new key personnel, who have documented training from City of Hope, in the protection of human subjects in research, less than 3 years old, will only be required to recertify within 3 years of their completion date.

Effective July 1, 2009

• Current and new key personnel with CRC more than 3 years old must complete the training within 6 months of the policy activation.

 

• Current and new key personnel with CRC less than 3 years old will only be required to recertify within 3 years of their previous certification date.

If you are an employee who has previously been certified to conduct human subject research at City of Hope, you can check your current status and date you were certified by clicking here and following the directions.  You will also be notified if you are approaching the end of your 3 year certification and will need to recertify.

Yes. Other training previously completed in satisfaction of City of Hope Human Subject Protection requirements (e.g. “Protecting Study Volunteers in Research”) is no longer accepted or valid going forward.  If you have completed this training before the July 1, 2009 deadline, your certification is valid 3 years from that completion date.

City of Hope policy on participation in human subject research requires that all key personnel involved with the planning, conduct, or analysis of clinical research needs to be trained in human subject research and protection, and needs to be certified and maintain their certification from the Clinical Research Training Office. This may include:

 

• Principal Investigators, CO-PI’s, participating clinicians, administrators, managers, nurses, CRA’s, study coordinators, secretaries or assistants, auditors, research support staff, regulatory committee members (OCRQA, CPRMC/PRMC, IBC, OIDRA, and IRB staff), and anyone else who participates at any level in clinical research.

• Students – Students with minor roles in clinical research are not required to be listed on the research protocol application.  However, it is the PI’s responsibility to ensure that these individuals receive both adequate training as well as Clinical Research Certification in accordance to the roles these individuals perform.

If key personnel listed on a submitted protocol are not on record as having completed, or in the process of completing (within the 6 month effective date) the certification process, they cannot be involved with human subject research at City of Hope, and will be removed from the protocol until certification is compete.  If certification lapses, recertification must be complete before any approval for continuation will be issued.

This certification and education process tailors training to the specific needs of those involved in clinical research at multiple levels.  After completing the short list of questions on the CITI website, you will be assigned a task specific clinical research group with a set curriculum (Group 1-6):

 

Group 1: Biomedical Research - Personnel involved with medical, therapeutic, physiological, or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices or other interventions. (Generally consisting of Principal Investigator (PI), Co-investigator, Participating Clinician, nurse coordinator, Clinical Research Associate (CRA), statistician, auditor, etc.).

 

Group 2: Social and Behavioral Research – Epidemiological, sociological, psychological, anthropological, or educational studies that typically involve direct contact with subjects. Does not include drug or device studies. Personnel involved with non-therapeutic/observational studies: (Generally consisting of non-interventional or epidemiological Principal Investigator (PI), Co-investigator, nurse coordinator, Clinical Research Associate (CRA), statistician, auditor, etc.).

 

Group 3: Both Biomedical and Social & Behavioral Research

 

Group 4: Data and Specimens ONLY or Minimal Risk - Personnel involved with human subject data and tissue specimens only (without human subject contact), or minimal risk research as defined by the IRB.  (Generally consisting of de-identified data, or secondary data sets and specimens only, this may include personnel in bioinformatics and some scientists.).

 

Group 5: Regulatory Committee Members and Staff – consisting of Institutional Officials and appointed members of these regulatory committees (including the IRB, CPRMC/PRMC, OCRQA, IBC, OIDRA), working with human subject research.

Group 6: All Support Staff – which support a PI and clinical studies (generally consisting of the administration, secretarial, clerical, and laboratory staff).

You must receive a total passing score of 85% after completing all the required training. You can track your progress on-line by clicking on the CITI Grade book. If you want to improve a score on a quiz, you may select view this Module again and repeat any quiz in which you did not score 100%.

Once initial clinical research certification has been completed you are required to recertify every 3 years.  You may however take any “optional” modules available to you to enhance your human subject education.

If you think you are placed in the incorrect group select “Add a course or update your learner groups” from the Main menu. This link will take you to the enrollment questions and permit you to change your Learner Group by providing new responses to the enrollment questions.

 

For additional assistance in selecting the correct learner group, contact Apryl Cato, acato@coh.org ext. 60504

Should you have any questions or concerns please contact the Clinical Research Training Coordinator, Apryl Cato, acato@coh.org ext. 60504