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U
§ 312.23
(a) ; (5) +
§ 312.23
(a) ; (6) +
§ 312.3
(b) - CRO +
§ 312.3
(b) - Sponsor +
§ 312.3
(b) - Sponsor-Investigator +
§ 312.3 - Clinical investigation +
§ 312.3 - IEC +
§ 312.3 - Investigator +
§ 312.30 +
§ 312.30
(b) (ii) +
§ 312.31 +
§ 312.32
(b) +
§ 312.32
(c) +
§ 312.32
(d) +
§ 312.32 - Adverse event +
§ 312.32 - Life-threatening Adverse event +
§ 312.32 - SAE +
§ 312.32 - Suspected adverse reaction +
§ 312.32 - Unexpected adverse event +
§ 312.33 +
