Frequently Asked Questions
Is there any work I can do on an FDA-regulated study on a contractual or sub-award basis?
12/12/2022
Yes, the following work can be done:
- data analysis (whether or not the data are identifiable)
- discussing a study with potential subjects (but not obtaining consent)
- pre-screening of records for eligibility determination
- procedures that will be performed as part of clinical practice and which would be performed exactly the same way regardless of whether the subject is in the study.
