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

Effect of Subject Safety (Deviation Tab)

Field Name Definition Requirement
Entry Instructions		 Responsible for Entry 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
Owned by:
Ilsa G. in SMPH Research Applications
Created:
2020-03-26
Updated:
2026-01-13
Sites:
SMPH Research Applications