Human Research Compliance Monitoring - Frequently Asked Questions

The Office of Compliance Monitoring provides answers to frequently asked questions. If you have a question that’s still unanswered, please contact our office at compliancemonitoring@ecu.edu.

How is monitoring defined for the purposes of the Post-IRB Approval Monitoring Program?

Monitoring as defined by Good Clinical Practice (GCP) guidelines is the act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, and the applicable regulatory requirements. For the purposes of the PAM program this definition of monitoring may also be applied to other human subject research as well as clinical trials.

Post-IRB approval monitoring is overseeing the progress of a clinical trial or other human subject research after it has been approved by the IRB.

Are there different types of monitoring?

Yes. There are three types of post-IRB approval monitoring that may occur:

• Routine post-IRB approval monitoring is monitoring of human subject research selected without bias based on specific, objective criteria including but not limited to those studies which are federally funded, internally funded, investigator-initiated greater than minimal risk, where ECU is relying on an external IRB for review and approval, or where the principal investigator (PI) is new or inexperienced. Routine monitoring may also be requested by the PI or study team.
• Focused monitoring is the review of an IRB-approved study where the monitoring focuses only on one aspect of the study. For example, review of only the consent documents and process, review of inclusion or exclusion criteria, etc.
• For-cause monitoring of a study occurs when there are perceived or confirmed ethics or compliance violations. For-cause monitoring may be requested by a department, study team member(s), UMCIRB staff, the IRB, or other institutional officials. For-cause monitoring visits are requested generally due to concerns regarding study compliance or subject rights and welfare. It may also be initiated due to complaints, repeated errors, or a lack of responsiveness by the PI to IRB requests.

How are studies selected for Post-IRB Approval Monitoring?

For routine or focused monitoring all IRB approved non-exempt studies are eligible for selection. Priority will be given to, but not limited to, the following:

• Investigator-initiated studies;
• Studies where the investigator is new or inexperienced;
• Studies not regularly monitored by other entities such as federally and internally funded studies;
• Studies reviewed and approved by an external IRB with an IRB Authorization Agreement (IAA) in place where ECU is relying on another IRB;
• Studies involving vulnerable populations; and
• Studies with high participant enrollment.

For-cause monitoring will occur upon request or as indicated based on perceived or confirmed ethics or compliance violations and may involve any IRB approved study.

Who is notified that a study has been selected for monitoring?

An email will be sent to the principal investigator as well as their department chair or associate dean for research and, if applicable, other study team members. The email will outline the type of monitoring visit that is planned, the study(ies) to be reviewed and the materials that will be required to be available, as well as a request for available dates and a location for the visit.

Can the investigator postpone or decline a monitoring visit?

A monitoring visit may be postponed to a later date if necessary. However, a monitoring visit cannot be declined. Every effort will be made to schedule a monitoring visit at the investigator’s convenience and at a time that will allow preparation.

What occurs during the Post-IRB Approval Monitoring visit?

The PAM staff will meet briefly with the PI and study team members to review the monitoring process, become familiar with the study set-up and files and answer any questions the PI or study team members may have. The PAM staff will then review all of the study materials and documentation. At the end of the monitoring visit the PAM staff may meet briefly with the PI/study team to provide a preliminary overview of the findings from the visit and answer any questions the PI or study team may have. The PI and/or a study team member delegated by the PI should be available throughout the monitoring visit to answer any questions that may arise. However, they do not have to sit with or be in the room with the monitor the entire time.

What will be reviewed during a monitoring visit?

At the time of a routine or for-cause monitoring visit all research and regulatory documents for the study must be available for review. For focused monitoring only, the documents applicable to the focus of the review must be available for review. Depending on the study, the list of items to be reviewed includes, but is not limited to:

• Current IRB approved protocol/research plan/grant and all previous versions;
• Current IRB approved informed consent documents and all previous versions;
• All original signed informed consent documents;
• Initial and all continuing review IRB submissions, corresponding requests for revisions and additional information and approval letters;
• All IRB regulatory documents including, investigator’s brochure, FDA 1572, etc. (if applicable);
• All amendments and/or revisions to the protocol/research plan/grant, consent, study personnel and corresponding approvals;
• If applicable to the study, all FDA required documentation and correspondence;
• If applicable to the study, all sponsor required documentation and correspondence;
• Documentation of all unanticipated problems involving risks to participants and others as well as IRB notification of such;
• Documentation of all study violations and deviations as well as IRB notification of such;
• Data Safety Monitoring Board (DSMB) reports as well as IRB notification of such;
• All other UMCIRB correspondence;
• Investigator and research staff training and certification logs if applicable; and
• Other applicable study logs (i.e. screening log, enrollment log, consent log, etc).

For studies where participants have been enrolled, participant records will need to be available for review as well. For focused monitoring only, the documents applicable to the focus of the review must be available for review. The review of participant records will include, but is not limited to:

• The informed consent documents, inclusive of, when applicable, parental permission and consent documents, assents and HIPAA authorizations;
• Documentation of informed consent;
• Inclusion and exclusion criteria documentation;
• Source documentation and data collection forms; and
• The participant’s medical record (if applicable to the study).

What are source documents?

Source documents are where data are first recorded. The source document verifies the study tests, procedures, evaluations and results, that the study participants are real, and that the intervention is carried out in accordance with the protocol. The source documents should reflect a subject’s participation in the study including eligibility and the course of events once the subject was enrolled in the study. A person monitoring the study should be able to reconstruct the participant’s course in the study by piecing together all of the data obtained from the original source. The only way to determine adherence to the IRB approved protocol is to refer to the source document. Data that are not documented or verifiable do not exist in the eyes of a sponsor or monitor.

Examples of source documents include:

• Questionnaires, surveys and participant diaries;
• Medical records including lab reports, pathology reports, radiology and surgical reports, medication logs, etc.; and
• Participant interviews.

St. Germain, D.C. (2012). Data management in clinical trials. In J.I. Gallin and F. P. Ognibene (Ed.), Principles and practice of clinical research (3rd ed., pp. 91-100). London, UK: Elsevier.

How long will a monitoring visit take?

The amount of time needed for a monitoring visit varies greatly. Generally, the PAM staff will want to meet with the PI and study team members for 15-30 minutes with that time split between the beginning of the visit and the end of the visit. The time needed to review the study files and documents depends on the amount of material and number of participants enrolled.

What happens after the monitoring visit?

Once the monitoring visit is complete the PAM staff will:

• Meet with the PI and any study staff they wish to include to discuss the findings and answer any questions that the study team may have;
• Generate a report which will summarize the findings and outline any necessary corrective actions that are required as well as the time frame for providing a response to the report (if required);
• Send a copy of the report to the PI and his department chair or associate dean of research. In the case of findings of serious or ongoing noncompliance the UMCIRB administrative director will also receive a copy of the report.