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