Thank you for your question. The IN

Thank you for your question. The IND regulations at 21 CFR 312.20(b) state "A sponsor shall not begin a clinical investigation subject to 312.2(a) until the investigation is subject to an IND which is in effect in accordance with 312.40." FDA's interpretation is that recruitment, obtaining informed consent, and screening subjects for a specific study that is subject to an IND is considered "beginning the clinical investigation" and such activities cannot be performed until an IND is in effect (30 days after FDA receives the IND, or earlier if the sponsor is so notified by FDA). Recruiting subjects, obtaining informed consent, and screening subjects for a specific IND study prior to the IND being in effect is not in compliance with the FDA regulations.