Tip of the Month
Monthly research compliance reminders and information.
Explore our Tip of the Month Archive below
June 2025
Investigational New Drug (IND) 
Conducting a clinical trial with an investigational drug as a sponsor-investigator?
You may need an IND application under FDA regulations (21 CFR 312.3).
Here’s what you need to know:
IND Requirements:
- An IND must be in effect prior to the initiation of a clinical study of an investigational drug.
- Investigational use can mean a product not approved by the FDA for any use, or the use of an approved product in a way that is beyond its approved labeling (e.g., use, route, administration, etc.).
- If a clinical trial is using an investigational drug to gather information about the products safety or efficacy, an IND may be required.
IND Process:
- Once determined an IND is required, a pre-IND meeting can be requested with the FDA.
- Finalized versions of all IND documents MUST be sent to the CRSO IND specialist, CRSO.FDAsupport@hsc.utah.edu, for review and approval prior to FDA submission.
- Complete protocol, informed consent and information about the investigational product are required for submission of the IND.
- The FDA has 30 calendar days of receipt of IND submission to review. After 30 days, the sponsor- investigator may begin the study unless the FDA notifies the site otherwise.
- Emergency use and expanded access (compassionate use) IND options are available if urgent access is needed for a patient.
CRSO IND specialist, Jonna Davis can assist Investigators through the process of preparing and submitting IND's. Contact CRSO.FDAsupport@hsc.utah.edu for assistance.
May 2025
Documentation of Protocol Training
Prior to any research-related procedures being initiated, initial protocol-specific training must be completed and documented for all research personnel listed on the Delegation of Authority (DOA).
Initial protocol-specific training will either be conducted by the Sponsor or Principal Investigator (PI), dependent on the research trial. Subsequent training for research personnel must be conducted by the PI, sub-investigator, clinical research coordinator or other appropriate research personnel who were in attendance at the initial protocol-specific training, or has otherwise been previously trained.
Protocol amendments may require additional training depending on the scope and nature of the changes.
Re-training of research personnel should occur if the protocol is amended with operational aspects that affect study procedures such as:
- Eligibility criteria
- Treatment parameters
- Changes to cohorts or study arms
- Safety or efficacy assessments
- Data collection and reporting
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.