Principal investigators and study directors

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​​​​​​​A. Background & Definitions

to be added

​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 2.1.1 Study (experimental) plan 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.​

​C​. Resources

to be added​

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