CLINICAL RESEARCH MONITORING

GUIDELINES TO THE USE OF SELF MONITORING PLAN FOR SPONSOR- INVESTIGATORS

Although it is strongly recommended for the Sponsor-Investigator to obtain outside monitoring for their study, under certain circumstances the Self Monitoring Plan may be used.

The following guidelines will assist in determining when Self Monitoring will be appropriate:

• The IRB and ORCRA have verified the monitor is qualified by training and experience to monitor the investigation
• The IRB and ORCRA have determined the monitoring schedule is appropriate based on following consideration:
  • Accrual rate
  • Study stage (e.g. start-up or follow-up)
  • Complexity of the trial
• The duration of the study is less than three months
• The study will be enrolling a small number of subjects (less than 15 subjects)
• The Sponsor-Investigator will submit a copy of the monitoring log to the IRB at progress report time
• ORCRA has determined that special circumstances surrounding the study will allow use of Self Monitoring

All Sponsor-Investigators wanting to use the Self-Monitoring Plan will be referred to ORCRA for further instruction.

Template for Self Monitoring (Doc)