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