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UUSOP-15: Internal Monitoring of University of Utah Clinical Studies

Version Date: February 7, 2024

  1. Introduction and Purpose
  2. Definitions and Acronyms
  3. Procedure
    1. Monitoring Expectations
    2. Scheduling Monitoring Visits
    3. Monitoring Visit Preparation
    4. On-Site Monitoring Visit Expectations
    5. Central/Remote Monitoring Expectations
    6. Monitor Visit Follow-up
    7. Additional Considerations
  4. Materials Required
  5. References
  6. Document Approval
  7. Revision History


Introduction and Purpose 

The sponsor of a clinical research study is responsible for quality assurance throughout all stages of the trial process by ensuring trials are adequately monitored. The purpose of monitoring is to ensure:

  • Human subject protection: The rights and well-being of human subjects are protected.
  • Reliability of trial results: The reported trial data are accurate, complete, and verifiable from the source documents.
  • Compliance with the current Institutional Review Board (IRB) approved protocol/amendment(s), with International Council for Harmonization (ICH) Good Clinical Practice (GCP), and with applicable regulatory requirements.

For investigator-initiated studies, the Principal Investigator (PI) has the regulatory responsibilities of both the sponsor and the investigator, and  therefore must ensure adequate monitoring is conducted.

Internal monitoring is primarily utilized for studies that do not have regular monitoring or oversight by an independent sponsor (industry or consortium); however, any study conducted at the University may benefit from internal review.

The Clinical Research Support Office Quality Assurance Group (CRSO QA) provides centralized monitoring oversight for clinical research studies conducted at the University of Utah as outlined in the CRSO QA Monitoring SOP (https://ctsi.utah.edu/crso/monitoring-qa/sop). The primary focus of the group is to monitor investigator-initiated trials where a University of Utah investigator holds an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). Individual groups, divisions, or departments may conduct their own internal monitoring; however, all clinical research studies conducted at the University of Utah are subject to internal monitoring by CRSO QA (exempting studies conducted at the Huntsman Cancer Institute (HCI)).

The Principal Investigator (PI) is required to make available the requested study-related material for the monitor or auditor.

 

Definitions and Acronyms 

Clinical Research: Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available. 

Clinical Trial: Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.

CFR: Code of Federal Regulations
CRF: Case Report Form
CRO: Contract Research Organization
EHR: Electronic Health Record
ERICA: Electronic Research Integrity and Compliance Administration
FDA: United States Food and Drug Administration
GCP: Good Clinical Practice
ICF:       Informed Consent Form
ICH: International Council on Harmonization
IDS: Investigational Drug Services
IRB: Institutional Review Board
LAR: Legally Authorized Representative
PI: Principal Investigator
SOP: Standard Operating Procedure
VPR: Office of the Vice President for Research

 

Procedure 

  1. Monitoring Expectations
    1. Monitoring will be performed as determined by the study’s sponsor. The extent and nature of monitoring visits (e.g., scope, method, frequency, duration, etc.) should be based on trial complexity and risk.
      1. Reviews may be conducted either in-person or remotely/centrally, or could utilize a combination of monitoring techniques and methods.
    2. Monitoring activities should be performed in accordance with the monitoring plan to confirm the trial is being conducted and documented properly.
    3. The monitor is responsible for communicating between the sponsor and the investigator.
  2. Scheduling Monitoring Visits
    1. Internal Monitoring visits should be scheduled with appropriate advanced notice (i.e., minimum of 4-weeks), unless mutually agreed upon by the monitor and study team, or in cases of for-cause monitoring or impending audit.
    2. Internal monitors must inform the study team of the expected number of days required to conduct the monitoring review.
    3. Monitors assigned to multiple active studies are encouraged to monitor one study at each “visit”. Exceptions may be made for multiple studies to be monitored in one visit if accommodations are prearranged.
      1. Participant charts and regulatory files for multiple studies cannot be provided at the same time.
      2. Separate confirmation and follow-up letters should be drafted for each study monitored.
    4. Monitoring visits must be scheduled at a reasonable and mutually agreed upon spaced interval. Exceptions can be made in rare cases, if the PI and study team can accommodate. Potential exceptions may include a Phase 1, first-in-human clinical research study.
    5. Internal monitors are expected to inform the study team of the following:
      1. The clinical research study to be reviewed.
      2. The participant research charts to be reviewed.
      3. Regulatory documents required to be reviewed.
      4. Investigational product required to be reviewed.
        1. Study monitors are not allowed to enter and physically inspect any University of Utah pharmacy. According to the Utah Pharmacy Practice Act Rule, Utah Administrative Code R156-17b, allowing unauthorized personnel into a pharmacy is unprofessional conduct. Monitors qualify as unauthorized personnel.
        2. For studies utilizing Investigational Drug Services (IDS):
          1. IDS uses remote monitoring practices in alignment with monitoring requirements stated in Guideline for good clinical practice E6(R2).
          2. For studies utilizing Primary Children’s Hospital (PCH) Pharmacy, the study team should work with the PCH pharmacy staff directly to schedule monitoring visits.
          3. Monitors will be provided access to the web-based investigation drug service system, Vestigo. Vestigo pharmacy monitoring appointments are requested here: https://pharmacyservices.utah.edu/investigational-drug-service/appointments
          4. If IDS’ remote monitoring practices are unable to meet a monitor’s needs, a request identifying a legitimate business need may be submitted to the Pharmacy Manager for an onsite monitoring visit. The Pharmacy Manager will assess the need and send the request and assessment to the IDS Medical Director and Chief Pharmacy Officer for approval/disapproval. The request can be submitted by email to investigational.pharmacy@hci.utah.edu.
      5. Possible dates for the visit; including total number of days required.
      6. For in-person monitoring: Times of arrival and departure for scheduled visit (acceptable monitoring hours are workdays between 8:00am and 5:00pm), number of monitors in attendance to accommodate sufficient space.
    6. Monitors are expected to bring/use their own laptops and cell phones.
    7. In case of cancelations, monitors should provide at least 48 hours’ notice of cancellation of the monitoring visit.
  3. Monitoring Visit Preparation
    1. The study team is expected to identify mutually available dates, reserve necessary space for monitors (for in-person monitoring), grant monitors access to electronically stored study records (for both central/remote monitoring), and schedule meetings with required parties (e.g. PI, IDS, etc.), as appropriate.
    2. The study team will notify potentially affected individuals of the upcoming monitoring visit.
    3. The study team will prepare the requested documentation for the monitoring visit, including but not limited to:
      1. Organize research charts for easy identification of source documents.
      2. Obtain and file any missing source documentation.
      3. Confirm data and case report forms (CRF) are complete and resolve any missing or inaccurate data.
      4. Confirm all essential documents are filed.
      5. Ensure training and delegation logs are current.
      6. Resolve any queries from the prior monitoring visits.
  4. On-Site Monitoring Visit Expectations
    1. The monitor should notify the study team upon arrival for the visit. A “sign-in” and “sign-out” sheet may be used as the study specific monitoring log.
    2. The study team will familiarize the monitor with their surroundings, including any office policies.
      1. Monitors may be physically located in a shared space with other site monitors.
    3. Monitors are expected to demonstrate professional and ethical behavior while performing the monitoring visit.
    4. Electronic Health Records (EHR) may be reviewed by internal monitors through physical and/or electronic means:
      1. Printed EHR records may be added to the participant research chart. Audit trails, electronic signatures, etc. are tracked within the EHR. Printed records will indicate the date, time, and individual who printed the record. Additional records can be printed from the EHR as needed.
      2. Digital EHR records may be electronically provided and reviewed in accordance with UU-SOP-06, Study Records Management: Monitoring & Auditing of Study Records.
    5. Monitors are not allowed within secured areas without the assistance of accompanied authorized personnel. This may include labs or other clinical workspaces.
    6. All materials provided to the monitor for review must be returned to secured areas at the end of each business day to ensure privacy and confidentiality of the research records.
    7. Monitors are expected to complete the monitoring visit within the scheduled timeframe for the visit.
    8. At the conclusion of the monitoring visit, a close-out meeting with the study team may be requested.
  5. Central/Remote Monitoring Expectations
    1. Requests for centralized/remote monitoring must be approved and arranged in advance, adhering to the same principles and processes used to schedule in-person monitoring visits.
    2. A monitoring visit log may be completed and electronically signed by the monitor. Alternatively, monitoring visit confirmation and final summary letters may serve as documentation of monitoring activities in lieu of a log.
    3. Digital EHR records may be electronically provided and reviewed in accordance with UU-SOP-06, Study Records Management: Monitoring & Auditing of Study Records.
    4. Monitor(s) are expected to complete the monitoring visit within the scheduled timeframe for the visit.
    5. At the conclusion of the monitoring visit, a close-out meeting with the study team may be requested.
  6. Monitor Visit Follow-up
    1. The monitor should provide a summary of their review in the form of a monitoring report and/or follow-up letter. These typically include details of monitoring activities, documents reviewed, findings, and recommended corrective actions.
    2. The monitoring summary should be submitted to the PI following the monitoring visit.
    3. The PI and study team should promptly address all outstanding findings and data queries, as well as develop and implement appropriate corrective action to prevent future recurrences of similar findings.
    4. For studies that do not have external monitoring oversight, all pre- and post-monitoring visit letters should be maintained with other essential study documents in the regulatory record.
  7. Additional Considerations
    1. Monitor(s) are expected to schedule close-out monitoring visits, “data crunches” or “data locks” with appropriate advanced notice.
    2. Any changes to assigned monitoring personnel must be communicated to the study team.

 

Materials Required 

  • Current IRB approved protocol/amendment(s)
  • Current IRB Approved Consent Form(s)
  • Participant research charts
  • Access to CRFs and/or electronic data capture (EDC) system
  • Access to essential documents / regulatory binders
  • Access to Vestigo

 

References 

 

Document Approval 

Erin Rothwell, Ph.D.
Vice President for Research, University of Utah
DATE: 3/21/2024

 

Revision History 

Version Date

Change Summary

07Feb2024

Original Version

 

Printed or photocopied versions are considered unofficial copies unless it is the original signed document.

Last Updated: 3/22/24