Quality Management

Managing the quality of clinical data does the following

  • Ensures management of compliance with the protocol, SOPs, and GCPs
  • Enables systemic problems to be resolved before the end of the study
  • Helps reduce data queries
  • Identifies ways to reduce cycle times for various processes
  • Ensures data integrity throughout the study's course and that the data collected are the data required by the protocol
  • Ensures the accuracy and consistency of data from entry into the CRF to final datasets reported in the final CSR
  • Plays a critical role in dealing with instances of nonconformity while carrying out clinical trials.


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