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gcp ich guidelines dosing irb adverse events📋 Description
- Screen healthy volunteers: exams, ECGs, labs, eligibility, dosing.
- Approve admissions and randomizations; document in source data.
- Maintain GCP/ICH knowledge; follow SOPs and Investigator 1572.
- Review Investigator's Brochure; ensure IRB protocol compliance.
- Medical management of adverse events; on-call coverage.
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