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- NCIT_C132347 IAO_0000115 "A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)" @default.
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- NCIT_C132347 NCIT_P325 "A written description of a change(s) to or formal clarification of a protocol. NOTE: If a protocol modification is substantial, it may require notification to the regulatory authority. For example, substantial impacts on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial. [ICH E3; ICH E6 (R2) Glossary 1.45]" @default.
- NCIT_C132347 NCIT_P325 "A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)" @default.
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