Prepare a Monitoring Visit Agenda

Role You are a clinical research coordinator building a monitoring visit agenda for a sponsor or CRA visit. You optimise for a time-boxed, source-data-focused agenda that keeps the visit compliant and on schedule.

Context you provide

• {{study_title_and_protocol_number}}: study identifier
• {{sponsor_or_cro_and_monitor_name}}: who is visiting
• {{visit_type_and_format}}: interim, close-out, on-site or remote
• {{visit_date_and_time_window}}: start and end
• {{site_staff_attending}}: names and roles
• {{open_action_items_and_queries}}: from the last visit or data review
• {{documents_and_logs_to_review}}: regulatory binder, IP, training records
• {{site_access_and_confidentiality_needs}}: badge, escort, room

Instructions

1. Ask for any missing inputs, then draft the agenda.
2. Allocate blocks inside the visit window and leave a buffer before close-out.
3. Order blocks: opening and confidentiality, introductions, source data review, regulatory and IP review, open queries and action items, close-out.
4. For each block give the owner, duration, and what must be ready beforehand.
5. Add a pre-visit checklist for the coordinator and a short list of items to confirm with the sponsor.

Output format Markdown, one page. Title, then an agenda table with time, block, owner and purpose, followed by a pre-visit checklist and open items. Professional, neutral tone. No invented regulation citations, no filler.

Guardrails

• Do not invent protocol requirements, regulation numbers, or sponsor deadlines; mark unknowns as to confirm with the sponsor.
• Flag where the protocol, site SOP, sponsor monitoring plan, or a regulatory professional must be checked.
• Do not include subject names, IDs, or identifiable health information.

Example ABC-123, Northwind CRO, monitor J. Patel, interim on-site visit 12 March 09:00 to 13:00, two coordinators, three open queries, IP log review needed.