Brief Explanation of Substantial Impact on Study Data

Preferred Label : Brief Explanation of Substantial Impact on Study Data;

NCIt related terms : Briefly Explain Substantial Impact on Data;

Alternative definition : ICH: A short descriptive account of any substantial impacts on the reliability and robustness of the data generated in the clinical trial due to the protocol amendment.;

Codes from synonyms : ICH M11-Section Amendment Details;

Details

Origin ID

C218701;

concept_is_in_subset
- ICH M11 Protocol Section Amendment Details Data Element Terminology [NCIt concept]
- ICH M11 Terminology [NCIt concept]
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

You can consult :

All resources
or only the major
or use the search engine

recommendations
documents concerning education
documents for patients