Data Integrity in Clinical Trials & IRT: FDA & MHRA concerns

Data Integrity in Clinical Trials & IRT: FDA & MHRA concerns

Breach of Data Integrity is in itself a grave issue but it becomes more serious when it gets associated with Clinical Trials. The FDA and MHRA are equally concerned and hence are taking the necessary measures. But it is time for you to prepare in advance through the knowledge of IRT to avoid rejection of your applications.

This paper especially focuses on the below mentioned topics:

  • Impacts on Data Integrity
    • Unblinding
    • Audit Trail
  • Understanding Data Integrity

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