On-site monitoring is one of the cost edging steps in trial management. Risk based monitoring is the option available to reduce cost and time for monitoring with improved data quality. Various tools are already updated with the GAP for data capture.
GAP provides sponsors with a comprehensive, systematic approach to risk-based monitoring. This approach can be applied in all relevant area for trial management. It is built on four key ideologies:
Identifying the major area of concern.
Creating risk profile and hurdles for the trial.
Modern tools combined with ancient process for complete and accurate data verification.
Team with expert opinion on pre or post risk management.
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