188.8.131.52 Principal investigators and study directors
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 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.
to be added
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