Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Our company elected for ex-US sites to NOT be under our IND. We are having them sign an appropriate attestation form instead. However, investigators in a few countries feel comfortable signing the 1572 (to be clear, in a particular country, either all investigators will use an attestation form or 1572). We are working with a CRO where confirming compliance to certain aspects of 21 CFR 56 is on us. If your company elected NOT to have ex-US sites under your IND, I have two questions for you. 

1. Where investigators are willing to sign the the 1572 but you aren't sure all commitments under Section 9 can be followed, did you have them sign anything else besides the 1572? (Since they are not under out IND, we aren't asking if you had them sign a waiver.) We are investigating if it's ok to have the PIs sign the 1572 and we still not bring them under out IND if we can't confirm compliance. 

2. How did your company ensure that the investigator's are able to follow all commitments of section 9? In some of these countries, we are having a hard time confirming certain parts of 21 CFR 56 can be followed per that countries own guidances/regulations. (To be clear, all sites  relevant to this conversation are in Europe.)

This message was posted by a user wishing to remain anonymous

Just signing does not ensure they are compliant to the FDA regulations, its your responsibility as a sponsor to make sure that they follow the GCP or any regulatory requirements by doing a mock inspection or due diligence of that site before enrolling patients for that site!
Original Message:
Sent: 19-May-2022 13:01
From: Anonymous Member
Subject: Non-US Clinical Sites Signing 1572 but not under IND

This message was posted by a user wishing to remain anonymous

Hello,

Our company elected for ex-US sites to NOT be under our IND. We are having them sign an appropriate attestation form instead. However, investigators in a few countries feel comfortable signing the 1572 (to be clear, in a particular country, either all investigators will use an attestation form or 1572). We are working with a CRO where confirming compliance to certain aspects of 21 CFR 56 is on us. If your company elected NOT to have ex-US sites under your IND, I have two questions for you.

1. Where investigators are willing to sign the the 1572 but you aren't sure all commitments under Section 9 can be followed, did you have them sign anything else besides the 1572? (Since they are not under out IND, we aren't asking if you had them sign a waiver.) We are investigating if it's ok to have the PIs sign the 1572 and we still not bring them under out IND if we can't confirm compliance.

2. How did your company ensure that the investigator's are able to follow all commitments of section 9? In some of these countries, we are having a hard time confirming certain parts of 21 CFR 56 can be followed per that countries own guidances/regulations. (To be clear, all sites  relevant to this conversation are in Europe.)