19.2 Monitoring Plans, Co-Monitoring and Communication
Key Takeaways
A monitoring plan links risks to methods, responsibilities, timing and follow-up.
Co-monitoring needs a clear purpose and coordinated access and communication.
Important decisions and action ownership should remain traceable across communication channels.
Monitoring Plans, Co-Monitoring and Communication
A monitoring plan should explain how the sponsor will obtain adequate assurance about participant protection, protocol conduct and reliable results. E6(R3) supports risk-proportionate monitoring that can combine site, remote and central activities. A plan is more than a visit calendar or an instruction to verify every field. It connects important risks to methods, responsibilities, timing, review and follow-up.
Identify critical data and processes, why errors would matter and which controls can detect or prevent them. Consider the trial's purpose, design, population, product, complexity, systems and endpoints. The strategy should be justified and adaptable as evidence accumulates. A low visit count is not proof of weak oversight, and frequent travel is not proof of adequate oversight.
What a usable plan addresses
- Who performs site, remote and central activities and how findings are exchanged.
- Which data/processes receive review and the rationale for coverage.
- Planned timing and triggers for additional or different activities.
- Access, confidentiality and blinding controls.
- Documentation, sponsor review, escalation and issue follow-up.
- How significant changes in risk or performance lead to reassessment.
No universal ICH rule prescribes 100% consent/eligibility SDV, the first three participants or a fixed percentage of low-risk data. Such requirements can be part of a particular justified plan. The underlying obligations still apply to every participant: consent, appropriate care, protocol compliance and reliable records. A monitoring sample does not authorise unsampled participants to receive lower standards.
Combining methods
Central review can detect cross-site trends, missing data, implausible patterns and important delays. Remote site monitoring can review appropriate systems/records and follow up specific issues. On-site activity can examine physical storage, facilities and source context that is difficult to assess remotely. The mix should fit the information needed and available controls.
A central signal should reach the people able to investigate it. If a site reports no AEs after substantial exposure, check whether data are current, the population/exposure differs or the collection process failed. Source review and investigator discussion may be needed. Do not automatically generate fictitious events or label the site fraudulent. Conversely, do not congratulate it solely because a dashboard looks clean.
Co-monitoring and training visits
The ECO tasks include co-monitoring and training visits. These can help evaluate or develop monitoring performance, support consistency or address a particular issue. Clarify the purpose, participants, authority and documentation in advance. Two monitors at a site should not duplicate queries, give contradictory instructions or broaden access beyond what is authorised.
A co-monitor may observe preparation, source review, prioritisation, communication and reporting. Feedback should identify evidence and an actionable development need. If a safety concern emerges, use the usual urgent route; do not postpone it until a training debrief. Any finding affecting trial conduct should reach the appropriate sponsor/site process, even if the visit also evaluates a monitor's skill.
Documenting important communication
A phone call, email, meeting or portal message can contain a consequential decision. Record the trial/site context, date, participants, issue, evidence, decision, action owner and due date as appropriate. Preserve relevant correspondence so a later reviewer can reconstruct what was communicated and whether it was followed. A casual statement remembered weeks later is weak evidence for a critical instruction.
| Communication | Key distinction | Follow-up |
|---|---|---|
| Proposed solution | Not yet an approved trial change | Obtain required evaluation/authorisation |
| Urgent safety notification | Needs timely clinical/operational action | Confirm receipt and action through the designated route |
| Routine monitoring finding | Requires evidence-based resolution | Track owner, deadline and completion evidence |
| System defect | May affect multiple sites or data streams | Involve responsible technical/quality functions |
| Training feedback | Develops competence | Verify the skill/process improvement |
Reports and site feedback
Monitoring documentation should communicate what was reviewed, significant findings, conclusions and actions taken or recommended, under the plan and procedures. Sponsor review should support appropriate oversight and follow-up. A site communication should provide the information needed to correct relevant findings. The specific document names and reporting deadlines come from the trial/organisation; ICH does not prescribe a universal five-day report and fifteen-day letter.
A monitoring report and follow-up letter can serve different audiences. Avoid copying confidential internal information or unnecessary participant identifiers into broadly distributed correspondence. Clear factual wording is more useful than accusatory language. Distinguish a confirmed deviation, a question awaiting evidence and an action already completed.
Reassessing the strategy
If problems recur, evaluate whether the original methods detect the important failure. Increasing SDV alone may not solve a missed safety-alert process or poor investigator oversight. Modify monitoring and other controls through the documented process, coordinate affected functions and verify effectiveness. Preserve the rationale for both the initial strategy and its change so the trial's quality approach can be understood at reporting and inspection.
Official sources
Checked October 18, 2026: ICH E6(R3), Principles and Annex 1, ICH E8(R1).
A co-monitor identifies an urgent safety issue during a training visit. What is appropriate?
Use the ordinary urgent escalation process without waiting for the training debrief.
Keep it only in the monitor’s performance notes.
Delay reporting because the visit was called training.
Ask both monitors to issue contradictory site instructions.
Sections you finish are checked off in the contents.