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
Owned by:
Molly H. in SMPH Research Informatics
Created:
2020-03-26
Updated:
2022-10-05
Sites:
SMPH Research Informatics