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Trial Monitoring
Trial Monitoring
StatPlus will conduct the following monitoring visits to ensure the trial is conducted in compliance with the principles of good clinical practice (GCP).
1. Pre-Study Visit:
To review the general objectives of the trial and assess whether patient numbers are adequate.
To visit and evaluate the facility where the study will be conducted.
To discuss issues related to the CRF and informed consent form with investigators.
To review drug information and protocol.
To ensure that all necessary and specific requirements are met before the study begins.
2. Initiation Visit:
To review responsibilities and monitoring practices with the investigators and study staff.
To review audit/inspection requirements with the investigators and study staff.
To ensure source documentation requirements safety considerations and requirements and laboratory procedures for handling specimens are fully understood.
To ensure that all investigational staff are aware of the final protocol, CRF, informed consent, and regulations of GCP.
To ensure that all safety considerations and requirements are fully understood.
3. Routine Monitoring Visits:
To update the file and review the study status.
To verify the source documents.
To evaluate adverse events and other safety-related issues.
To review the CRF and drug supplies and randomization code envelopes.
To review monitoring/data issues identified with the study staff.
To constantly ensure integrity of the trial.
4. Close-out Visit:
To retrieve and review all CRFs still at the study site.
To collect all returned and unused study drug.
To ensure that all tasks have been completed by the end of the visit.
To ensure that all CRFs have been completed and signed upon the notification that the last patient has completed the study.
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