22. Are there any expectations of which metrics or key performance indicators or methodologies should be used in central/statistical monitoring?
It is understood that many organisations are developing quality metrics or key risk/performance indicators to assist in determining which investigator site to visit, often this is part of the audit function rather than monitoring, but there does not appear to be a list of accepted or validated metrics for sponsors to use. The methodology would include ranking investigator sites with respect to the metrics to identifying outlying sites. Some organisations are also using multivariate statistical methodologies enabling the use of several metrics simultaneously. It is recommended that the methods and metrics to be used are documented in the monitoring procedures. Some sponsors have used the following metrics:
- Recruitment rate
- Screen failure rates
- CRF submission/completion times against actual patient’s progress in the trial
- Query rates
- Time to queries resolution vs number of active queries (site level)
- SAEs reported
- Numbers of missed or late visits/data
- Number of Subject withdrawals/dropouts
- Numbers of protocol/GCP non-compliances recorded/reported
- eCRF – audit trail information on completion times in relation to visits or expected timescales
The MHRA is willing to publish further examples of metrics/methodologies being used to assist sponsors in developing processes and procedures and undertaking research. It is possible that organisations may be undertaking similar approaches already. Sponsors, who wish to provide examples for consideration for publication here, should contact the MHRA GCP Inspectorate.
The MHRA encourages further research and publications into the use of key performance indicators and statistical methodology and validation of their effectiveness in the identification of non compliant sites. Sponsors undertaking such research are encouraged to contact the GCP Inspectorate.
GCP.inspectors@mhra.gsi.gov.uk
Version 1: 22 February 2013
The examples are not intended to be definitive approaches. They are not endorsed or recommended by the MHRA
