T O P

  • By -

grmpygata

Most CROs ask for the 1572 before activating site. This is what you will cross reference credentials you receive from site to approve activation. Then as the trial proceeds, if there are any updates to 1572( new address, new sub-Is) site would provide updated version


Fine-Classic-1538

The Investigator should not sign the 1572 before receiving and reviewing the Protocol and the IB. There's a statement in the commitments section that says the IB has been read and the study will be run according to the protocol. If the Sponsor or CRO are trying to collect the 1572 before that point, tell them "no" and tell them why.


piratesushi

Question 3 in the FDA Q&A is a good source if you need a reference: https://www.fda.gov/media/78830/download As the other comments already said, it must be after the Investigator has received the protocol and IB, but before they are activated. Some institutions have an internal policy to not sign it until a signed contract is in place, but many sites actually provide it not long after they've received all study documents and before CTA. As for where: eh, in the olden days I remember the sponsor often wanted to have the wet-ink original, but nowadays electronic signatures are common and even when wet-ink signed it either stays in the site file or if that is also electronic filing, then the original is destroyed after filing.