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- i. New Protocol 21 CFR 312.30(a)
- x. Drug accountability 21 CFR 312.57a
- ii. Changes in the protocol 21 CFR 312.30(b)
- iii. New investigator 21 CFR 312.30(c)
- iv. Information amendments 21 CFR 312.31
- v. IND safety/adverse events reports 21 CFR 312.32
- vi. Annual reports 21 CFR 312.33
- vii. Withdrawal of an IND 21 CFR 312.38
- viii. Discontinuation of an investigation 21 CFR 312.31(a)2
- ix. Financial disclosure reports 21 CFR 312.57d
- x. Drug accountability 21 CFR 312.57a
- xi. Financial interest 21 CFR 312.57b
- xii. Case Histories 21 CFR 312.62b