Pre-study visits: besides routine GCP agenda, special procedures for evaluating the risk of fraudulent behavior are implemented, and feasibility of the protocol under site specific conditions is evaluated. All facilities to be used in the trial (pharmacy, labs) are also visited, and suitability for the particular trial is checked with responsible staff.

Site initiation visits: besides routine GCP agenda, a practical emulation of the flow of subjects, source documents, research forms, and activities during the subject’s visit is performed with emphasis on prevention of protocol and GCP violations.

Interim monitoring visits: by the CRAs paying special attention to detailed source documents check, any safety issues or protocol violations are detected, allowing timely initiation of corrective actions.

During the recruitment period, the CRAs and PMs prepare documents for financial operations and orders for the accounting department:

  • Administration of investigators’ payments
  • Reimbursement of study subjects‘ expenses, if applicable
  • Endorsement and payments of vendors’ invoices
  • Invoicing of the sponsors

Close-out visits

By the CRAs going through extensive training scheme, high quality monitoring is insured. Special attention is given to complex and careful source documentation review, to ensure both patients safety and data quality. Monitoring reports are produced within 10 days or as greed with Sponsor and site always receives a follow-up letter from the visit with a summary of activities and issues to resolve.

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