Trial monitoring
StatPlus will perform the following monitoring visits to ensure the trial is conducted in compliance with principles of good clinical practice(GCP).
1. Pre-Study Visit
To review general objectives
To assess whether patient numbers are adequate
To visit and evaluate the facility
To discuss issues in CRF informed consent form
To review drug information and protocol
2. Initiation Visit
To review responsibilities and monitoring practice with investigators and study staff
To review audit/inspection requirements with investigators and study stuff
To ensure source documentation requirements safety considerations and requirements and laboratory procedures for handling specimens are fully understood
To ensure investigators and study staff have reviewed the applicable information regarding the study drug and the conduct of the study
To assure all clinical supplies on site and are stored at proper location
To ensure all investigational staff aware of final protocol,CRF,Infomed consent and regulation of GCP
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 CRF
To review 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 tasks have been completed by the end of visit
To ensure that all CRFs have been completed and signed upon the notification form the investigators the last patient has completed study