Tip of the Month
Monthly research compliance reminders and information.
Explore our Tip of the Month Archive below
April 2025
Informed Consent Process Note 
The informed consent process must be documented in the research record. The note should include the following details:
- Informed Consent Form (ICF) obtained voluntarily
- Participant consented in their primary language
- ICF signed before any research procedures were performed
- Date and time the discussion began
- Whether the participant had time to review the ICF and ask questions
- Who reviewed the ICF with the participant
- Date and time the consent was signed
- Confirmation that a copy was provided to the participant to take home
The informed consent process note template can serve as a helpful reminder of the key details to document at the time of consent. The example below captures proper documentation of the consent process with additional consent details that should be considered when documenting.
Template links below for research teams to download and adapt for their own use.
March 2025
Study Close-Out
The completion or early termination of a research study is required to be reported to the IRB. The Principal Investigator (PI) must submit a Final Project Report to the IRB, once ALL the following criteria have been met:
- Enrollment is permanently closed.
- All participants have completed research interventions, including data collection and/or follow-up.
- Identifiable data is no longer being collected on participants (e.g. letters, phone calls, interviews, re-contacting, etc.).
- Data analysis indicates no new information needs to be provided to participants.
- Data analysis is complete or is continuing only on de-identified data.
Multi-site industry sponsored studies require additional criteria to be met:
- All correspondence and queries related to the study have been addressed.
- The investigator’s participation in the study is complete.
- Study close-out (termination) visits have been completed, if applicable.
Upcoming RQCN Event:
Look Who's Doing Research Now! What Does it Mean for Walgreens, Walmart, Etc., to Be Conducting Human Subject Research?
Presented by Dr. Mark Munger
Tuesday, March 4, 2025, at 2:00PM
February 2025
Delegation of Authority
Prior to beginning ANY research-specific tasks, study team members should be delegated tasks specific to their role(s) on the study's Delegation of Authority (DOA) log by the Principal Investigator (PI). The start date on the DOA log should correspond to the date that the assigned duties begin.
For most tasks, proper training and addition to the DOA is enough to begin performing the delegated duties. However, to obtain informed consent, a study team member must also be included in the IRB application and authorized in ERICA by the PI before proceeding.
The DOA log should be completed at study initiation and maintained throughout the trial to account for new study personnel and turnover.
A DOA template is available on the OQC website for research teams to download and adapt for their use.
University of Utah Clinical Research Standard Operating Procedures
Upcoming RQCN Event:
Look Who's Doing Research Now! What Does it Mean for Walgreens, Walmart, Etc., to Be Conducting Human Subject Research?
Presented by Dr. Mark Munger
January 2025
Documenting Eligibility
Eligibility should be reviewed and documented by the study coordinator and PI, or
delegated Sub-Investigator, PRIOR to enrollment and randomization.
The following documentation practices are recommended:
Print the inclusion/exclusion criteria directly from the current IRB approved protocol in ERICA.
Assess each eligibility criterion via a checkmark with pertinent notes written, as needed. Complete the checklist with the signature and date by the investigator and file the completed checklist in the participant source file. Any associated documentation to verify/confirm each inclusion/exclusion criteria should also be filed.
Signature of the investigator to complete the form and confirm eligibility criteria should only be done after all eligibility criteria are confirmed. There should be no criterion pending prior to enrollment and randomization.
For therapeutic studies, all screening labs and/or imaging and diagnostic reports MUST be documented as reviewed by the PI or delegated Sub-Investigator prior to enrollment and randomization.
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.