1.5.2.7 Quality professionals
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A. Background & Definitions
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B. Guidance & Expectations
- Verifies in real time that the requirements for quality of the study related activities have been fulfilled according to study plan
- Ensures research team's compliance with the study protocol and the complete and acccurate documentation of the study
- Checks data integrity and sample tracebility and reports results to study director; verification of study plan adherence; follow up on study plan deviations
C. Resources
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