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.
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.
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.
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.
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.
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.
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).
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 three years. You may however take any optional modules available to you to enhance your human subject education.
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 email@example.com or (626) 256-4673 (HOPE), ext. 60504
Should you have any questions or concerns, please contact Clinical Research Training Coordinator Apryl Cato at firstname.lastname@example.org or (626) 256-4673 (HOPE), ext. 60504