Conducting the Visit: SDV, IP, Documents and the Closing Meeting

Part of Clinical Research Associate (CRA) Training: Monitoring Visits.

About 6 minutes. Free, in your language, no account needed.

Why this matters

This is the core of the job. Everything else in this course supports the hours you spend at a site comparing records, checking storage, and talking to people.

Opening the visit

Check in through the site's own process. Meet the coordinator and, where possible, the investigator.

Confirm the agenda: what you will review, the priorities, the expected timings, and any constraints such as limited medical record access or the investigator being available only for one hour.

Then ask what has changed since the last visit. Staff changes. Process or facility changes. New issues: missed visits, complaints, serious events, equipment problems. Sites volunteer more in this opening conversation than in any formal review, if you make it a conversation.

Source data verification and source data review

Two different activities. Source data verification compares reported data against source records. Source data review assesses whether the source itself is logical, complete and consistent with the participant's clinical situation.

Both focus on what is critical to quality. Remember that E6(R3) section 3.11.4.5.4(b) allows checking on the basis of samples supported by data analytics; 100 percent verification is not required.

Informed consent. The correct version was used. The participant signed and dated personally, before any study-specific procedure. The person taking consent signed and dated and was delegated at that time. All required signatures, initials and dates are present and legible. Re-consents for amendments were completed, and before the changed activity applied.

Eligibility. Every inclusion criterion met and no exclusion criterion present, verified from source: laboratory results, imaging, medical history. Assessments performed within the protocol's windows. The investigator's eligibility confirmation signed and dated before randomization.

Visit data. Visit dates against scheduled windows. Protocol-required assessments performed: vital signs, laboratory tests, electrocardiograms, efficacy assessments, questionnaires, imaging. Consistency between source and the data system.

Concomitant medications and medical history. All clinically relevant medicines and conditions recorded. Cross-check against the medical record for prohibited medicines and for anything that would have met an exclusion criterion.

Adverse events and serious adverse events. Events in source appear in the data system. Seriousness, severity, causality and outcome documented. For serious events: reported to the sponsor and, where required, the ethics committee within the protocol's deadline from site awareness, with supporting documents such as hospital records available.

Look for under-reporting actively. Read hospital letters, new medications and missed visits, not just the adverse event log.

Investigational product

Storage. Correct conditions — temperature range, light protection, security. Temperature logs complete, legible and in range, with any excursion documented and handled. Access restricted to authorized personnel.

Accountability and reconciliation. Compare shipment records, receipt logs, dispensing logs, returns and destruction records. Reconcile at participant level: dispensed, returned, remaining. Check for dosing errors and unreturned product.

Compliance. Verify pill counts or device usage logs against diary entries and visit data. Where adherence is poor, confirm it is documented and managed as the protocol requires.

Regulatory binder and essential records

Ethics approvals, initial and continuing. Current and historical protocol, Investigator's Brochure and consent form versions. The signed delegation log with roles and start and stop dates. Staff CVs, licenses and training records. Safety letters and notifications, filed and with evidence of investigator review. Training logs for protocol, systems and safety updates.

Managing issues during the visit

Classify issues by severity as your organization's procedure defines — commonly critical, major and minor.

Discuss findings as they arise, not only at the end. Real-time discussion allows correction and clarification, and prevents a closing meeting that feels like an ambush.

Provide guidance: how to correct data properly, when a note to file is appropriate, and how to prevent recurrence through retraining or a process change.

Keep the tone collaborative and professional. You are not there to punish, and a site that fears you will hide things from you.

The closing meeting

Who: at minimum the investigator or their designee, and the coordinator.

What:

• Summarize what was reviewed: which participants, what product review, which documents.
• Present findings by severity. Critical issues first — unreported serious adverse events, consent violations, eligibility breaches. Then major, such as systemic data entry delays or incomplete logs. Then minor.
• For each issue, state the action required, the responsible person, and a target date.
• Invite questions and feedback, including on study processes and burden.

Do not leave without the investigator knowing about any critical finding. That conversation is not delegable to an email.

In practice

At a VT-301 visit, Leah compares source records with the data system for six participants.

For one, the adverse event log shows nothing between visits 3 and 4. But a letter in the medical record, filed under routine care, describes an emergency department attendance for palpitations during that period.

She raises it during the review rather than saving it for the closing meeting. The coordinator had not seen the letter; it had been filed by the practice's administrative team without being flagged.

The investigator reviews it the same afternoon, records the adverse event, assesses causality, and determines whether it met a seriousness criterion.

The finding Leah writes is not "adverse event not reported". It is that the site has no process for reviewing incoming correspondence for study participants, and that this is likely to have affected other participants. The corrective action is a weekly review of incoming correspondence for enrolled participants, with a named owner.

She then reviews correspondence for every enrolled participant at that site, and finds one more.

Finding the event is monitoring. Finding the process that lost it is the job.

Key takeaways

• Source data verification compares reported data with source; source data review assesses whether the source itself is coherent, and both focus on what is critical to quality.
• Consent verification checks the version, the participant's own dated signature before any study-specific procedure, and the delegation status of the person who took consent.
• Investigational product review covers storage and temperature logs, participant-level reconciliation across shipment, dispensing, returns and destruction, and adherence.
• Discuss findings as they arise, so that the closing meeting confirms rather than ambushes.
• Never leave a site without the investigator personally knowing about a critical finding, and write findings against the process that caused them rather than the instance alone.