Tip of the Month
Monthly research compliance reminders and information.
Explore our Tip of the Month Archive below
December 2024
Data Safety Monitoring Board (DSMB) 
Things to Remember:
- Submit DSMB reports to the IRB in a timely manner. This can be done using the report form function or as part of a continuing review submission.
- Review the Safety Monitoring section of the IRB application regularly and update the DSMB section as necessary (i.e., such as changes to the defined frequency of DSMB meetings or adjustments to the number of board members).
- File documentation supporting or clarifying why a DSMB meeting was postponed or canceled, if applicable.
- Track decisions or recommendations made regarding the study by the DSMB and implement if required.
* These reminders may not be applicable for all studies, especially industry sponsored trials.
November 2024
Prior & Concomitant Medication Documentation
Current and prior medications should be documented and reviewed by the Principal Investigator (PI) or delegated Sub-Investigator(Sub-I) priorto enrollment/administration of study intervention andmaintained for the duration of the study to prevent potential interactions with study intervention and help identify eligibility exclusion medications or required medication washout periods.
October 2024
Elevate Your Research with a Self-Assessment Review
What is a Self-Assessment Review?
- A Self-Assessment Reviewis a tool provided by the OQC to assist investigators and
research teams conducting research. A self assessment may be initiated by one of the
following methods:
- Voluntarily created or at the request of a member of the research team
- Selection by the OQC to participate
- Required by the OQC in conjunction with, or because of, a separate OQC review/assessment
How is it done?
- Once a Self-Assessment is completed by the research team and submitted, the OQC will contact the PI and research team to schedule a meeting to review the Self-Assessment, discuss any findings, and provide recommendations and resources for the team. A link to the checklist is provided in the section header.
How do I request a Self-Assessment Review?
- An investigator or researcher can request a self-assessment through the IRB’s online application system,ERICA.
September 2024
Common Informed Consent Form (ICF) FDA Inspection Observations (FDA 483)
During an FDA inspection, inadequate participant protections noted during review of the ICFs could lead to an FDA 483 being issued. These notice of inspection observations may indicate non-compliance with FDA regulations.
August 2024
Protocol Deviations
A protocol deviation is ANY departure from the defined procedures and treatment plans
outlined in the protocol version or application version submitted and approved by
the IRB.
Deviations are generally unplanned and/or unintentional events that require review
and documentation from the Principal Investigator (PI).
Examples of Protocol Deviations
Performance of an unapproved research procedure
Failure to adhere to inclusion/exclusion criteria
Failure to consent on the most current, IRB approved ICF, PPF, Assent version found in ERICA
Incorrect or missed research lab assessment or procedure
Participant visits missed or outside permissible windows outlined in the approved IRB research protocol
Participant non-compliance with research requirements
Use of prohibited medications
Incorrect investigational drug dosing, administration or missed dose
July 2024
ClinicalTrials.gov Compliance Reminders
When clinical trial registration information should be submitted to ClinicalTrials.gov as required by 42 CFR Part 11.
Registration
Applicable Clinical Trials (ACTs)* and NIH funded trials are required toregisteronClinicalTrials.gov within 21 days of enrollment of the first subject.
i.e., date of when the 1st participant signs a study consent form.
Updates
An active study record should be updated at least every 12 months, or within 30 calendar days of a change to protocol information, including recruitment status or primary completion date.
Even if nothing has changed in the study, the record requires yearly review and approval.
Results Reporting
Study results of ACT studies (42 CRF 11) and/or NIH-supported clinical trials are required to be reported no later than one year after the primary completion date.
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date.
* An ACT refers to a trial involving drugs, biologics, or devices that must be registered and have results posted on ClinicalTrials.gov. The criteria defining an ACT are outlined here: ClinicalTrials.Gov ACT Checklist.pdf
If you need assistance with ClinicalTrials.gov registration or results reporting, please contact the University’s ClinicalTrials.gov administrators at OQC@utah.edu
Tips and Reminders: Adverse Event Reporting
Not all adverse events will constitute unanticipated problems (UP) that require reporting to the University of Utah IRB. To be considered reportable, the event must be unexpectedANDrelatedAND present a greater risk of harm to the participant. See below for more details!
Unexpected
- Was the event unexpected from either participant perspective or the study team perspective?
- Was the event unforeseen in terms of nature, severity, frequency, etc.?
- Was the risk NOT listed in the consent form?
STOP
If the AE was expected, it does not need to be reported to the IRB, but may still need to be reported to the sponsor or other applicable agencies
Related
- “Related” means attributable to procedures of the research i.e., if the participant was not in the study, could this event have occurred because of other factors?
- If an event is deemed only “possibly” related to the research, it does not typically qualify as an UP.
- If there is not enough info to attribute relatedness to the research, the event likely does not meet the U of U IRB’s reporting threshold. If future information about the event is discovered, a report form may be necessary at that time.
STOP
If the AE was unrelated, it does not need to be reported to the IRB, but may still need to be reported to the sponsor or other applicable agencies
Greater Risk of Harm
- This may include physical, psychological, economic, or social harm, etc.
- Please consider whether the consent form is being updated with a new risk. If so, it is likely participants are placed at a greater risk of harm because of the event.
STOP
If the AE does not pose a greater risk of harm previously known, it does not need to be reported to the IRB, but may still need to be reported to the sponsor or other applicable agencies
If all three criteria above are met, the adverse event may represent a possible unanticipated problem and reported promptly to the IRB using the Report Form application in ERICA.