Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
Is limited to review of unanticipated problems.
Must occur within 12 months of the approval date.
Is not required unless additional risks have been identified.
Must be conducted by a convened IRB.
Continuing review of an approved and ongoing study posing more than minimal risk that…
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
