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AgendaHealthcareStrategy & planning

Clinical monitoring visit

330 minutes 10 blockspro Runs with Pro

A full-day interim monitoring visit plan: consent review, SDV, safety reconciliation, drug accountability, site file and a close-out with the PI.

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330 min · 10 blocks, drawn to scale Fits exactly
  1. Opening meeting with the PI and study coordinator, 20 minutes 20
  2. Enrollment, screening log and recruitment, 15 minutes 15
  3. Informed consent review, 45 minutes 45
  4. Source data verification and review, 115 minutesDiscuss 115
  5. Lunch, 30 minutes 30
  6. Safety: adverse event and SAE reconciliation, 30 minutes 30
  7. Investigational product: accountability, storage and temperature logs, 30 minutes 30
  8. Investigator site file and delegation log, 20 minutes 20
  9. Close-out meeting with the PI: findings, deviations and actions, 20 minutes 20
  10. Follow-up letter timing and next visit date, 5 minutes 5
083165248330 min
  1. +0′Opening meeting with the PI and study coordinatorTip: Confirm the scope of the visit and that records and people are available. Ask what has changed since the last visit: staff, equipment, facilities, amendments.20 minInfo
  2. +20′Enrollment, screening log and recruitmentTip: Compare screened, enrolled and withdrawn against target. Ask why screen failures happened; patterns point to an eligibility problem.15 minInfo
  3. +35′Informed consent reviewTip: For every new participant: the correct approved version, signed and dated by the participant and the person taking consent before any study procedure, a copy given, and the process noted in the medical record.45 minDiscuss
  4. +80′Source data verification and reviewTip: Follow the monitoring plan. Eligibility, primary endpoint data and serious adverse events come first. Raise queries in the EDC as you go so the site sees them today.115 minDiscuss
  5. +195′Lunch30 minBreak
  6. +225′Safety: adverse event and SAE reconciliationTip: Match AEs in the source to the EDC and SAEs to the safety database. Check each SAE reached the sponsor within the protocol's timeline.30 minDiscuss
  7. +255′Investigational product: accountability, storage and temperature logsTip: Count against the dispensing log, check expiry and any temperature excursions, and confirm how they were handled.30 minDiscuss
  8. +285′Investigator site file and delegation logTip: Current ethics approvals, protocol versions, CVs and training records. Does the delegation log match who actually did each task?20 minDiscuss
  9. +305′Close-out meeting with the PI: findings, deviations and actionsTip: Walk through each finding with an owner and a due date. Agree which are protocol deviations. The PI's oversight is part of the record, so keep them in this meeting.20 minDecide
  10. +325′Follow-up letter timing and next visit dateTip: Tell the site when the follow-up letter will arrive (your SOP sets the timing) and book the next visit.5 minWrap-up

In short

A clinical monitoring visit is a sponsor or CRO monitor's visit to a trial site to check that participants are protected and the data are accurate. This full-day interim monitoring visit agenda covers consent review, source data verification, safety reconciliation, drug accountability and the site file, ending with a close-out meeting where the PI agrees every action.
Time
5.5 hours, one day
Blocks
10, opening to close-out
For
CRAs, monitors and site staff
Plan
Pro

Updated October 4, 2026

What's inside

By the end of this meeting, the site's consent, data, safety reporting and drug accountability have been checked, and the PI has agreed every finding and action. The full agenda is drawn to scale above: every block has its own timer when you run it live.

How to run it

  1. 1Send a confirmation letter with this agenda before the visit so the site books the PI for the opening and close-out meetings.
  2. 2Work through the blocks in order; consent and eligibility come before SDV because they're the findings that matter most.
  3. 3Use the decide block at close-out to agree each action with an owner and a date while the PI is in the room.
  4. 4Turn the summary into your monitoring visit report and the follow-up letter to the site, as ICH E6 good clinical practice expects after each visit.

Questions people ask

What happens during an interim monitoring visit?
The monitor reviews informed consent, verifies source data, reconciles adverse events, checks drug accountability and the site file, and meets the investigator to agree findings and actions.
What is the difference between a site initiation visit and an interim monitoring visit?
The initiation visit trains the site before the first participant enrolls. Interim monitoring visits happen while the trial runs, to check consent, data and safety reporting.
How long does a monitoring visit take?
Usually one or two days, depending on the number of participants since the last visit and how much source data verification the monitoring plan requires.

Run it with your group

pro
  • A timer for every block on the shared screen
  • Results, decisions and actions in the summary
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Free to open and edit. Running it live needs Pro, free for 14 days on every new account.

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