May 2026

The Compliance Monitoring Program of the Office of Human Subjects Research (CMP) conducts monitoring reviews of research protocols approved by the JHM IRBs and external IRBs in cases where JHM relies on the IRB of an external organization. The CMP’s activities are known as Post-Approval Monitoring. The reviews are primarily intended to ensure the conduct of approved research at Johns Hopkins proceeds according to the IRB approved protocol. The purpose of monitoring reviews is to:

• Assess adherence to Federal Regulations
• Assess adherence to JHM IRB Policies and Guidelines
• Affirm that the rights and safety of human subjects have been properly protected
• Provide education to investigators and study teams

The majority of monitoring reviews are conducted remotely and the monitoring process generally follows these steps:

• Principal Investigators are contacted by email, and asked to complete a questionnaire, which is returned to the CMP monitor. Currently, the PI is requested to provide the CMP monitor with a de-identified list of all participants who have signed an informed consent form.
• The responses to the questionnaire guide the CMP monitor to request in a follow-up email specific study documentation, which is to be provided to the CMP monitor via OneDrive within eight (8) business days.
• After the requested documents are received and reviewed, the CMP monitor prepares a report identifying deficiencies or actionable non-compliance issues, along with specific corrective actions.
• This report is sent to the Principal Investigator who must address all corrective actions and return the report to the CMP monitor.
• After the report is received, the CMP monitor schedules a close-out meeting with the PI (and invited study-team members) to review the report.

Frequently Asked Questions:

1. What is the difference between a “routine” review and a “priority” review?

Routine Reviews: Protocols are selected by performing a query of the eIRB system to identify studies that have not been monitored and have been IRB enrolling for  at least one approval cycle.

Priority Reviews: Protocols that are identified as “priority” are scheduled for review from six months to one year after initial approval. Priority studies meet at least one of the following criteria:

• High Risk (meeting one or more of the below conditions.)
  • A study drug(s) or other product is being used in the study that has a likelihood of causing a reaction (e.g., allergic reaction, hypersensitivity, or physiologic change) and could require immediate intervention to treat the reaction.
  • There are research activities or drugs administered in this protocol that are intended to induce symptoms in research participants, such as: procedures to provoke an allergic reaction, induced sputum, or exercise stress test.
  • Research participants will undergo high risk, invasive procedures that are NOT part of prescribed routine clinical care for the participant.
  • The Principal Investigator is conducting a greater than minimal risk study for the first time.
• Annual Priority Monitoring: Studies that are commercially funded are reviewed annually by the CMP. See https://www.hopkinsmedicine.org/institutional-review-board/about/fees for the monitoring fee schedule
• The study is greater than minimal risk and is under the oversight of an External IRB of Record (e.g. the study is not overseen by the JHM IRB)

2. How many research participant records will be requested by the CMP monitor?

For both Routine and Priority Reviews, from the list of consented participants provided by the PI, 10-30% of total participants will be selected at random from whom informed consent forms, case report forms, and other information will be requested for the CMP monitoring review. If there are fewer than 4 participants enrolled, a review of all research participant records will be performed.

3. What is source documentation or data?

Source documentation or data is the collection of clinical notes (e.g., from the participant’s medical record) , laboratory results, or diagnostic test results that verify participant  eligibility and collected study data. Source documents are placed in the participant’s research record, but can be accessed in Epic, if applicable.

4. What consent documentation problems are frequently identified during a review?

• Consent forms not dated by the participant, investigator, and/or consent designee
• Use of a consent form that is out-of-date or not displaying the JHM IRB approval “stamp.”
• Consent form signed by a consent designee not authorized by the IRB as an informed consent designee
• Failure to have the optional study components  signed/dated by the participant

5. What other types of issues are commonly identified during a review?

• Deviation from  the IRB approved protocol (i.e. an unapproved change in study procedure)Missing consent forms
• Failure to report adverse events, unanticipated problems, or protocol deviations
• Consent forms signed after the implementation of research procedures
• Deficient documentation of eligibility assessments

6. Does the Principal Investigator (PI) need to be present during the Closeout meeting?

PI attendance is highly encouraged and may be required. The closeout meetings are conducted remotely via Zoom or MS-Teams. If the PI is unable to attend, a study-team member must be designated to meet with the CMP monitor to review the monitoring report, discuss any corrective action requirements or recommendations, and address any questions. The closeout meeting typically lasts about 30-45 minutes.

7. What happens after the CMP review is completed?

The final visit report will list actionable findings, as well as areas in which deficiencies were identified, and given to the PI. In cases where problems are noted, the investigator has the opportunity to respond to recommendations of the monitor or to provide clarifications or to develop a plan of corrective action to eliminate the potential for future problems. After the PI has entered the responses to findings and addressed all corrective actions, the CMP monitor sends the complete report to the chair of the JHM IRB responsible for study oversight and the Associate Dean for Human Research Protections. The report will either  be scheduled for review by the convened IRB (Note: for priority studies or when actionable findings are listed in the report) or reviewed by the IRB chair only when administrative findings are noted.

8. Who can I contact with questions about the CMP’s monitoring process?

If you have any questions about the CMP’s monitoring process, please contact any of the CMP team members at: https://www.hopkinsmedicine.org/institutional-review-board/about/compliance-monitoring/contact