MHRA produced FAQs for monitoring
The following frequently asked questions (FAQs) are presented below:
[LIST=1][*]What is the purpose of overseeing and monitoring a clinical trial?[*]What are oversight and monitoring activities?[*]What are the important factors in determining the oversight and monitoring strategy?[*]How should the oversight and monitoring strategy be documented?[*]How can the oversight and monitoring strategies be adapted?[*]Is it possible to have different intensity or focus of the oversight and monitoring activities?[*]Does adaptive monitoring always have to be trial-specific – for example, in relation to the trial risk assessment?[*]Is it possible that not undertaking any oversight or monitoring is acceptable?[*]What should the documented oversight and monitoring strategy contain?[*]Who should review the oversight and monitoring strategy documentation?[*]Does the strategy documentation need to be global or country specific?[*]Does the strategy documentation have to be followed?[*]Can the strategy documentation be amended?[*]Are there examples of trial documents that outline oversight and monitoring strategy?[*]What role do oversight committees have in monitoring a clinical trial?[*]Is it necessary to perform regular on-site visits?[*]Is it necessary to perform an investigator site assessment visit?[*]Is it necessary to perform an investigator site initiation visit?[*]Is it necessary to perform an investigator site close out visit?[*]What activities comprise “central monitoring” of a clinical trial and should they be documented?[*]What is statistical monitoring?[*]Are there any expectations of which metrics or key performance indicators or methodologies should be used in central/statistical monitoring?[*]What are the benefits of conducting an on-site visit?[*]How should non-compliance be dealt with when it is identified?[*]How important is the accuracy of the clinical trial data?[*]Is it necessary to perform 100% source data verification (SDV)?[*]How do I show that the monitoring strategy has been complied with?[/LIST]