Part 2, Ch. 7 - HawkIRB Section VI Subject Enrollment

Section VII of the HawkIRB application asks the investigator to provide the number of adult and minor subjects that will be enrolled in the study.  The number provided in the response is the maximum number of subject that can be enrolled without submitting a modification to increase the enrollment number.  This number cannot be exceeded without prior IRB approval for an increase in the approved number of subjects.  Investigators should consider the potential for screening failures or dropouts and be sure to request an appropriate number of subjects.