1.5.2.4 Principal investigators and study directors

A. Background & Definitions

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* Enforces a climate of good scientific practice, rigor and reproducibility, and continued excellence in preclinical data.

Establishes effective communication with research team and quality professionals (if present); enables training for research team so that approriate expertise is guaranteed to conduct with the appropriate quality needs.
Develops the 2.1.1 Study protocol and ensures all procedures specified in the study protocol including amendments are followed and all data generated during a study are fully traceable and documented. Makes study protocol and amendments available to research team and quality professionals.
Ensure that all raw data generated are fully documented and recorded; Signs and dates the final report to indicate acceptance of responsibility for the validity of the data; Ensures that, after completion of the study, the study protocol, the final report, raw data and supporting material are archived.

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