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A new NIH Policy
Discuss University Research Education Mission Describe progress in Harmonization and Simplification Discuss the New NIH GCP requirement Review University of Pittsburgh COI training requirements Update on Clinicaltrials.gov
Provide education for the diverse research conducted at the University of Pittsburgh
Provide educational materials that improve the quality and safety of research
Comply with federal training requirements Present educational material that is up to date. Will open new RCCO education center in 2017
The institution is presently reviewing the requirements Goals◦ Provide the highest quality training for researchers◦ Harmonize training frequency when possible◦ Harmonize training resources (CITI training)◦ Follow Federal requirements for training Example: New NIH mandate for GCP
NIH Policy University of Pittsburgh Policy
1. Effective: January 1, 2017 2. What: All NIH-funded “Clinical
Trials” require Good Clinical Practice training
3. Who: All Investigators and research team members who are engaged in the conduct, oversight or management of clinical trials
4. When: Before they participate in any research activities
1. Effective: January 1, 2017 2. What: All “Clinical Trials”
regardless of funding source require Good Clinical Practice training
3. Who: All Investigators and research team members who are engaged in the conduct, oversight or management of clinical trials
4. When: Before they participate in any research activities
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
A predefined process ( e.g. randomization) specified in an approved protocol that stipulates the assignment of research subjects(individually or in clusters) to one or more arms (intervention, placebo, or control) of a clinical trial.
Manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.
Drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques);
Delivery systems (e.g., telemedicine, face-to-face interviews); Strategies to change health-related behavior (e.g., diet, cognitive
therapy, exercise, development of new habits) Treatment strategies; prevention strategies; and, diagnostic
strategies
The pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.
Positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers
Reading comprehension and /or information retention Positive or negative changes to disease processes Positive or negative changes to health-related behaviors; and, Positive or negative changes to quality of life.
Manage participant recruitment and enrollment, including obtaining consent
Perform research procedures or evaluations Contribute significantly to the collection and recording of
research data or Contribute significantly to data management Have more than minimal contact with the research subjects or
their identifiable study records or specimens
Hospital staff (including nurses, residents, fellows, or office staff) who provide ancillary or intermittent care but do not make a direct and significant contribution to the study, or
Administrators or individuals who perform routine or supportive tasks related to the research
GCP for Clinical Trials Involving FDA regulated research◦ For those who currently
participate in an FDA regulated clinical trial or those who plan to in the future
GCP for Clinical Trials Involving Behavioral or non-FDA regulated Research◦ All other researchers
Students, faculty and staff conducting research must complete, at a minimum, the following courses: 1. Responsible Conduct of Research (Question 2)
2. Research with Human Subjects (Question 3) – choose: a) Biomedical Research or b) Social and Behavioral Research orc) Undergraduate Student Research
Refresher courses must be completed every 4 years.
DO NOT submit a modification to make the change.
Use the Activity Button
The Human Research Protection Office (HRPO) will not issue approvals on new protocols submitted after January 1, 2017 unless all required courses for all investigators are completed.
HRPO will notify PI on submission of individuals listed on the OSIRIS application who are deficient in training.
PI is responsible for evaluating all members of research team for applicability of GCP training.
New NIH mandate is for training◦ Assures well trained research team
ClinicalTrials.gov is for Registration of trials◦ Design of federally funded research◦ Results of federally funded research
Overview of COI training requirements
David T. WehrleDirector/COI Office
The University is required to provide training in conflict of interest (COI) that complies with relevant federal regulations and sponsor requirements
• Regardless of sponsor, for successful new applications for research funding that are submitted after February 1, 2017, release of funding will be contingent upon all Investigators on the project having completed COI training within four years prior to the date of release
• This supersedes the previous requirement that training be completed prior to submission of a research funding application
• Investigators must refresh their COI training every four years (not every three years which was previously the case)
• The CITI system automatically sends Investigators emails reminding them when they need to re‐take this training
• Those who have taken the original CITI COI course can take a shorter, refresher course when re‐taking the training
• All Investigators must use the CITI COI course to fulfill Pitt’s COI training requirements
• Many Investigators who are not supported by agencies of the Public Health Service (PHS) have completed the ISER module to fulfill their COI training requirement, but may now use only the CITI COI course
• To allow time for this change, the deadline for these Investigators to complete the CITI COI course is February 1, 2018, or prior to commencing work on a PHS‐funded research project (whichever comes first)
• Pitt accepts CITI COI training completed by individuals who are coming to Pitt from other institutions (They only need to review the module in Pitt’s CITI COI course that describes our institution’s policies)
• Investigators outside of the University of Pittsburgh who are performing PHS funded research on behalf of Pitt must complete COI training. The University of Pittsburgh will accept COI training from outside institutions that have PHS‐compliant policies. If the outside institution does not have a PHS‐compliant COI policy, the Investigator must complete Pitt's CITI COI training module
• Individuals who do not conduct any research and those conducting research without any external funding do not need to complete the COI training module (unless they have disclosed outside financial interests on their University Faculty/Researcher COI disclosure form, or have been directed by their department chair or dean to complete COI training)
• Investigator includes any individual, regardless of title or position, who is (or may be perceived to be) independently responsible for or significantly influences, the design, conduct or reporting of the research
• The Principal Investigator (PI) is responsible for identifying the individuals who meet this definition
• The COI Training webpage (accessible at http://www.coi.pitt.edu/COItraining.htm) of the COI website provides very good, specific examples of who may and may not be considered Investigators
• When funding is awarded, the PI must provide the Office of Research with a list of those who meet this definition and the date on which they completed the CITI COI course
• A template table is available on the COI Training webpage which can be used as a resource to capture this information
• It is the responsibility of the PI to maintain a copy of the course completion certificates on file for all Investigators and to update the list as personnel changes occur
• The CITI COI course is accessible at www.citi.pitt.edu
• Investigators completing CITI COI Training for the first time:
– After logging in, under "My Learner Tools for University of Pittsburgh," click "Add a Course"
– On the next "Curriculum" screen you need to only answer "Yes" to Question 1 to complete COI Training. (If you do not wish to complete the non‐COI training modules described in questions 2 through 8 at this time, select "Not at this time" for each question.)
• Please note that if you click on the link for CME/CEU credit, you will be directed to the University of Miami website. If, and ONLY if, you want to receive CME/CEU credit for the training, will you need to pay the associated fees. There is NO fee to complete the training module and receipt of CME/CEU credit is NOT required to meet the University of Pittsburgh's COI training requirements.
• An administrative interface is available within HSConnect that allows authorized users to view who has taken the CITI COI course and the date on which these individuals have completed the course
Questions?
Kelly Dornin-Koss, MPPM, RN, CCRCResearch Conduct and Compliance OfficeUniversity of Pittsburghhttp://www.rcco.pitt.edu/Email: [email protected]
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FDAAA• Applicable clinical trials (ACT)
NIH• Every clinical trial funded in whole or in part by the NIH
ICMJE• The International Committee of Medical Journal Editors (ICMJE)
requires trial registration as a condition of publication.
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https://www.clinicaltrials.gov/ct2/manage-recs/background
Applicable Clinical Trials generally include interventional studies (with one or more arms) of FDA-regulated drugs*, biological products*, or devices** that meet one of the following conditions:
• The trial has one or more sites in the United States• The trial is conducted under an FDA investigational new drug
application or investigational device exemption• The trial involves a drug, biologic, or device that is
manufactured in the United States or its territories and is exported for research
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* Other than Phase I drug studies** Other than small feasibility studies of devices
Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect that will be evaluated a health related, biomedical, or behavioral outcome?
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https://grants.nih.gov/clinicaltrials_fdaaa/ACTs_under_FDAAA.htm
The rule takes effect January 18, 2017.
The Protocol Registration and Results System (PRS) will be ready to support the requirements by this time.
Parties have an additional 90 days after the effective date to come into compliance (April 18, 2017).
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The rule requires the NIH to post all information submitted to the ClinicalTrials.gov within 30 days of receipt
Responsible parties have
◦ 15 days to correct registration information
◦ 25 days to correct results information records
Records that don’t fulfill the quality control review criteria will be posted with a disclaimer
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The NIH Policy and the Dissemination of NIH Funded Clinical Trial Information
◦ Requires applicants to submit a plan outlining how they will meet the policy’s expectations.
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Under FDAAA 801, basic results must be reported for ACTs no later than 12 months after the Primary Completion Date (PCD) has been reached.
The PCD is the date that the final subject was examined or received an intervention for the purposed of final collection of data for the primary outcome, whether the clinical trial was conducted per protocol or was terminated.
The full protocol and statistical analysis plan must be submitted at the time of results submission.
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The NIH will check grant and progress report forms for certification that information has been submitted
NIH will verify that required information has been submitted before releasing any remaining funds for a grant or new funds for a future grant
NIH will withhold funding from the grantee in the absence of verification
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Under FDAAA801◦ Public notice of noncompliance and violations◦ Withholding of NIH grant funds◦ FDA Sanctions◦ Civil monetary penalties (up to $10,000/day)
https://clinicaltrials.gov/ct2/manage-recs/fdaaa#AreTherePenalties
• Under ICMJE◦ Cannot publish in journals following ICMJE Policy
(1000+ journals) http://www.icmje.org/journals-following-the-icmje-recommendations/
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Updates can be made by PI, Primary CRC or Secondary CRC
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Updates are required within 30 days when there is a change in overall study status, recruitment status or contact information
Must be updated q 12 months
At a minimum, the Record Verification Date must be updated to reflect the current month and year information reviewed on ClinicalTrials.gov
Reminders with renewal letters Reminders three months prior to primary
completion date Study termination
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Participation in ClinicalTrials.gov task force calls, the third Thursday of each month
Hiring of new ClinicalTrials.gov Coordinator to assist investigators with registration and results reporting
To send a message to the ClinicalTrials.gov staff:
Login to the ClinicalTrials.gov website Go to the “Contact ClinicalTrials.gov PRS” link
in top right corner of your study home page. Include the ClinicalTrials.gov NCT# in the
message and request a one-on-one call to discuss your need for help.
They will reply to the e-mail listed on your home page.
BMJ 2016; 352i637 -http://www.bmj.com/content/352/bmj.i637
The Chronicle of Higher Education http://chronicle.com/article/US-Medical-Schools-
Are/235352
ICMJE requirements ◦ http://www.icmje.org/recommendations/browse/publishing-and-
editorial-issues/clinical-trial-registration.html
Piller, Charles; December 13, 2015 Stat Failure to Report: A STAT investigation -https://www.statnews.com/2015/12/13/clinical-trials-investigation/
www.clinicaltrials.gov
http://www.ecohsr.pitt.edu/documentation-tools/
Why Should I Register & Submit Results: https://clinicaltrials.gov/ct2/manage-recs/background
Website: http://www.ecohsr.pitt.edu/ClinicalTrials/
