(a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained.
CFR (b) clearly states that 'an investigator shall promptly report to the sponsor was related to the IND safety reporting requirements in 21 CFR. NIA Safety Training Course
21 cfr 312.64 - official siteI am [Redacted] giving feedback to [Redacted] currently drafting a clinical protocol. The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol. Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan. Strategic Human Resources Management Program for HR Professionals. Behavioral intervention studies G.
Richards seven: 21 cfr 312.64
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