Topics Map > OnCore > Data Field Definitions > Non-oncology

Effect of Subject Safety

Field Name Definition Requirement
Entry Instructions
QA
Effect On Subject Safety Enter the assessment of the deviation, as made by the PI or sub-I, on the following:
  • Effect on Subject Safety, including a description of how the determination was made.
  • Effect on Data Integrity, including a description of how the determination was made.
  • Effect on the subject's willingness to participate, including a description of how the determination was made.
  • If there is/was no effect on any of the areas listed above,enter “None” and explain.
Recommended No




Keywords:Deviation subject safety   Doc ID:99556
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-03-26 09:14 CSTUpdated:2022-10-05 09:09 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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