1.5.2.4 Principal investigators and study directors

​​​​​​​A. Background & Definitions

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​B. Guidance & Expectations​

​* 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 Study (experimental) plan and ensures all procedures specified in the study plan including amendments are followed and all data generated during a study are fully traceable and documented. Makes study plans 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 plan, the final report, raw data and supporting material are archived.​

​C​. Resources

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