6 Monitoring Tasks a CTMS Should Take Off a CRA's Plate

A Tufts CSDD study of global CRA workload found that monitors spend about 41% of their time on site. Roughly 22% goes on off-site monitoring work, such as visit preparation, report writing and follow-up, 18% on travel, and the remaining 19% on administration and training (Applied Clinical Trials).

The off-site and administrative share is where a CTMS earns its keep. Most of that time is spent finding information that already exists somewhere, putting it into a document, and chasing what happens next. The six tasks below are the ones a CTMS should carry, so CRAs spend more of their time on judgement and site relationships.

Where monitoring time goes

1. Pre-visit preparation

Before each visit, a CRA needs the last report, open action items, enrolment since the last visit, adverse events, consent versions in use and outstanding queries. When these live in different places, preparation becomes a search exercise. A CTMS that pulls them into one briefing lets the CRA start with what needs attention.

2. Scheduling and confirmation letters

Confirmation letters follow a standard structure: date, attendees, scope and documents to prepare. Generating them from the visit record saves time and keeps the scope consistent with the monitoring plan.

3. Visit reports

A template that pre-fills site details, study status and findings still open from the last visit removes a lot of retyping. The CRA's effort should go into describing what was found and why it matters.

4. Follow-up letters on time

Most monitoring plans set a deadline for sending follow-up letters after a visit. When the letter is drafted from the signed report and the due date is tracked, late letters show up before they become a finding.

5. Action items that close

An issue raised at one visit and still open three visits later is a common audit observation. Each action item needs an owner, a due date and a status that the CRA, the site and the study manager can see, with reminders between visits.

6. A cross-site view for managers

ICH E6(R3) describes monitoring as part of sponsor oversight and expects it to be proportionate to the risks of the trial (ICH E6(R3), EMA Step 5). For managers, that means seeing report timeliness, letter timeliness and action-item ageing across CRAs and sites without asking for a status update.

Monitoring workflow checklist

• Pre-visit briefing pulls history, actions, AEs and consent status automatically
• Confirmation and follow-up letter templates are linked to the visit record
• Visit reports pre-fill known information and carry forward open findings
• Report review and sign-off are tracked with dates
• Follow-up letter due dates are calculated from the monitoring plan
• Every action item has an owner, due date and status
• Managers can see timeliness and ageing by CRA, site and study

What this means by role

• CRAs: less time assembling information before and after a visit, more time on source review and site support.
• Clinical trial managers and clinical operations managers: report and letter timeliness become visible without chasing.
• Clinical operations directors and associate directors: a cross-study view of monitoring quality supports oversight under E6(R3).
• Quality and compliance directors and QA auditors: action items with dates and closure records answer a common audit question directly.
• CRCs and principal investigators: clear action lists with due dates mean fewer surprises at the next visit.

How Cloudbyz approaches this

Cloudbyz CTMS is built natively on Salesforce and manages monitoring visits, visit reports, issues and action items alongside study and site records, with Cloudbyz EDC and eTMF on the same platform. Report templates, approval steps and timelines can be configured per study.

The Cloudbyz CRA Monitoring Copilot, built on Agentforce, is a read-first, draft-only assistant for monitors. It assembles a one-step pre-visit briefing covering visits, reports, actions, AEs and consent, points to the forms and subjects to prioritise for verification, drafts follow-up letters and summaries from signed reports only, and chases open action items between visits. It never advances status, sends or signs; every judgement and send stays with the CRA. Cloudbyz describes it as cutting visit preparation from two to four hours to under 15 minutes; actual time savings depend on the study and configuration.

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