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Clinical Research Certification and Recertification

Clinical Research Certification and Recertification
City of Hope recognizes the need to provide training and continuing education for individuals involved in human subject research. Raising the standards of our education and continually updating our curriculum is a necessary step in providing quality, safe, and ethical patient care and clinical research. In an effort to promote the highest ethical standards in research involving human subjects, beginning July 1, 2009, the Clinical Research Certification and Recertification will be overseen by the Clinical Research Training Office (CRTO).
 
All City of Hope personnel conducting human subject research must maintain an "active" Clinical Research Certification. To sustain an "active" Clinical Research Certification status, recertification will be mandated every three years. Part of the Clinical Research Certification education process will utilize the Collaborative Institutional Training Initiative (CITI) Program. CITI is an online human subject research education program created, developed, and maintained by experts from the human subject research community. The program will consist of task specific human subject research education modules, and clinical research HIPAA training with a set of curriculum that has been selected by City of Hope.
 
Clinical Research Certification (CRC) Education
 
CRC Basic Course
First time certification

  • Task Specific Modules
  • Responsible Conduct of Research
  • HIPS Curriculum
 
CRC Recertification Course
3 Year Recertification
 
  • Task Specific Modules
  • Responsible Conduct of Research
  • HIPS Recertification Curriculum
 
In order to fulfill the Clinical Research Certification requirement you must complete all curriculum displayed within “My Courses” on your CITI profile. For additional information on how to register click here for detailed instructions, or go to www.citiprogram.org to begin your registration process.  You may also contact Apryl Cato (ext. 60504).
 
 

Access to the CITI Program

Answers to questions about the Clinical Research Certification and Recertification process.

How do I register?

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

How do I verify my training?

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.

Can I access certification materials outside of City of Hope?

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

How much time will it take?

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.

How do I access the recertification modules?

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.

CRC FAQs

Our FAQs section provides answers to questions about the Research Certification and Recertification process.
 
 
 

What if I completed Clinical Research Certification (CRC) within 3 years of the July 1, 2009, policy start date?

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

When will I be required to complete the Clinical Research Certification or Recertification?

Effective July 1, 2009, current and new key personnel with certification more than three years old must complete the training within six months of the policy activation. Current and new key personnel with certification less than 3 years old will only be required to recertify within three years of their previous certification date.

How do I check the status of my previous certification?

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 three-year certification and will need to recertify.

Does the Clinical Research Certification Program replace the previous requirements?

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 three years from that completion date.

Who needs to be certified?

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 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.

What will happen if I am not certified?

If key personnel listed on a submitted protocol are not on record as having completed, or are in the process of completing (within the six-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 completed before any approval for continuation will be issued.

What training do I need to complete?

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 iInvestigator (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 and  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).

What is the passing score on the quizzes?

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%.

When do I have to renew my training?

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

What if I am placed in the wrong group?

If you think you've been placed in the incorrect group, select "Add a course" or update your Learner Group 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 Clinical Research Training Coordinator Apryl Cato at acato@coh.org or (626) 256-4673 (HOPE), ext. 60504

Who can I contact if I have any questions?

Should you have any questions or concerns, please contact Clinical Research Training Coordinator Apryl Cato at acato@coh.org or (626) 256-4673 (HOPE), ext. 60504
Education and Training
As one of only a select few National Cancer Institute-designated Comprehensive Cancer Centers in the country, City of Hope integrates all aspects of cancer research, treatment and education. We offer a range of programs serving students, post-doctoral trainees, health and medical professionals.

City of Hope’s Irell & Manella Graduate School of Biological Sciences equips students with the skills and strategies to transform the future of modern medicine.
City of Hope has a long-standing commitment to Continuing Medical Education (CME), sharing advances in cancer research and treatment with the health-care community through CME courses such as conferences, symposia and other on and off campus CME opportunities for medical professionals.
Local and national conferences, in-depth educational training and a certification program provide both current and aspiring health professionals opportunities to further their knowledge in their fields of interest.
 
 
City of Hope offers a range of programs and services, such as Graduate Medical Education & Clinical Training, that serve students, post-doctoral trainees, medical professionals and staff.
The goal of the Postdoctoral Training Office is to ensure the postdoctoral experience at City of Hope is rewarding and meaningful to all participants.
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