ON-SITE MONITORING VISIT AGENDA/CHECKLIST
The following activities will be performed during the visit. Please have all documents related to these
activities completed and available for review.
√ Monitoring Visit Items
Review of investigational drug supply and comparison to
documentation.
Review of regulatory study document file (refer to ICH
GCP Guideline List of Essential Documents).
Review of facilities and equipment.
Verification of investigator compliance with protocol and
any amendments.
Verification that investigator and staff are adequately
informed about the trial.
Verification that the investigator has accurately prepared
and provided all required reports to the sponsor, IRB,
and institution, and that each document is complete,
accurate, dated, legible, and properly identifies the trial.
Notification of the investigator of any CRF discrepancy,
entry error, omission, or illegibility.
Verification that the CRF corrections are made with dated,
initialed documentation and explained, if required.
Communication of deviations from procedures, GCP or the
protocol to the investigator, and the actions required to
secure compliance.
Verification that essential documents are maintained.
Training of the investigator and/or staff in areas that
require additional training.
Feb. 2014
Original: Regulatory Binder
√ Monitoring Visit Items
Review of informed consent documents for each subject.
Review of CRFs and comparison to source
documentation (e.g., medical record).
Verification that only eligible subjects are enrolled.
Verification that any therapy modifications are
documented.
Verification of complete and accurate reporting of adverse
and serious adverse events.
Verification that any missed visits, tests, or procedures are
accurately documented on the subject's CRE
Verification that all subject withdrawals or drop-outs are
reported and explained.
Verification that only authorized persons have written on
the CRE
Assessment of the financial status of the study and
requesting payment in accordance with the study
contract.
Preparation of a report of monitoring findings (preliminary
during the visit and final after the visit).
Copy: As Needed