ACRP CCRC MANDATORY KEY QUESTIONS & ANSWERS 2024

What are expected or possible consequences of over-estimation of recruitment potential? - - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - Subject welfare When is the investigator allowed to deviate from the protocol? - When there is an immediate hazard to a patient. If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? - - The Sponsor - IRB/IEC - Regulatory Authorities Which conditions should be fulfilled when enrolling a subject into your trial? - - Subject meets all inclusion criteria - Subject has given written informed consent You've been delegated to handle the storage and inventory of IP. The study drug must be stored below 25C/77F. On a summer Monday morning you discover that the temperature recording machine in the storage room has failed so you doin't know what the temperature has been over the weekend. You check the current temperature; it's 24C/75F. What should you do? - - Contact the Sponsor, explain what happened and ask for instructions - Set up a site staff meeting to conduct a root cause analysis