What does an ARC do during a monitoring visit?

During a monitoring visit, the clinical research associate (CRA) verifies that the trial is proceeding in accordance with the protocol and Good Clinical Practice, that patients’ rights and safety are protected, and that the data recorded are accurate and verifiable. Specifically, they review informed consent forms, compare data to source documents, review adverse events, verify medication management, and follow up with the investigational team. At CLINACT, a CRO of the MultiHealth Group, our CRAs conduct these visits throughout France and internationally.

What is a monitoring visit?

Monitoring is one of the sponsor’s obligations. It allows the sponsor to ensure, on a site-by-site basis, that the trial is being conducted properly. Monitoring visits, also known as follow-up visits, take place regularly between the setup visit and the closing visit.

The frequency of these visits is not specified by regulation. It is defined in the monitoring plan, based on the rate of patient enrollment, the complexity of the protocol, and the center’s risk level. A center that enrolls a large number of patients or shows deviations will be visited more often. Increasingly, these on-site visits are combined with remote monitoring.

Before the visit: Essential preparation

An effective visit requires several days of preparation. The CRA schedules the appointment with the investigator and the team, and then reviews:

• the data entered into the eCRF since the last visit and any open queries;
• the tasks that were left unfinished during the previous visit;
• the center's metrics: inclusions, deviations, data entry delays;
• patients whose data must be verified as a priority, according to the monitoring plan.

He then sends a confirmation letter to the center specifying the purpose of the visit, the patient records to be made available, and the people to meet with.

During the tour: 7 checkpoints

1. Consent Forms. For each new patient, the ARC verifies that the consent form has been signed and dated in the correct version before the first study-related procedure.
2. Eligibility. Does each patient included in the study meet all the inclusion criteria and none of the exclusion criteria?
3. Data. The CRA compares the eCRF data with the source documents and reviews their clinical consistency. We explain this distinction in detail in our article on SDV and SDR.
4. Safety. Have all adverse events been identified and recorded, and have serious events been reported in a timely manner?
5. Investigational Medicinal Products: Receipt, Storage Conditions, Temperature Logs, Dispensing, Record-Keeping, and Returns.
6. The Investigator's Workbook. Update documents, approvals, the delegation list, and training records.
7. Deviations. Identification, documentation, and tracking of deviations from the protocol, in coordination with the center.

The visit concludes with a discussion with the investigator. The ARC presents its findings, discusses areas for improvement, and provides an update on recruitment. This moment is essential: it helps maintain the center’s trust and motivation.

According to the study, the ARC also coordinates with the pharmacy, the laboratory, or the imaging department. For example, it verifies that samples are collected, centrifuged, and shipped in accordance with the laboratory manual, or that imaging exams meet the specified parameters. These ancillary processes are often the source of “silent” discrepancies, which are only discovered during analysis if no one has checked them.

After the visit: report and follow-up

In the days that follow, the ARC prepares an inspection report for the developer. The report describes what was verified, the findings, the identified deviations, and the actions decided upon. The ARC also sends a follow-up letter to the center summarizing the issues to be addressed, along with the responsible parties and deadlines.

Following up on actions is what distinguishes effective monitoring from superficial monitoring. Any action that remains unresolved between visits must be followed up on, and any recurring problem must be escalated to the clinical project manager. Significant deviations require analysis and a CAPA plan.

Between site visits, work continues remotely: reviewing entered data, answering questions from the center, and tracking patient enrollment. This regular engagement prevents issues from piling up and makes on-site visits more efficient.

The Qualities of a Good ARC

Competence	Why She Matters
Rigor	Each audit must be thorough and well-documented
Knowledge of the protocol	To immediately identify inconsistent data
Clinical significance	To understand medical records and identify an unreported event
Pedagogy	To train and support the teams at the centers
Diplomacy	How to correct discrepancies without damaging the relationship with the center
Organization	To manage multiple locations, travel, and tight deadlines

The ARC is often the only physical link between the sponsor and the site. Its ability to build a relationship of trust with the research team directly influences recruitment and data quality.

The profession is evolving with risk-based monitoring: fewer systematic checks, more analysis, and greater support for the centers. The ARC is becoming a true partner in ensuring the quality of the study, rather than merely a data verifier.

Outsource Your Monitoring with MultiHealth Group

MultiHealth Group’s Clinical Research Coordinators (CRCs), supervised by experienced project managers, monitor your studies both on-site and remotely. Learn more about our monitoring expertise or contact our teams.

Frequently Asked Questions About the Monitoring Visit