Bonjour, Nathalie - welcome to working on your first IND!
Here are my thoughts on this. If you are still employed by the Sponsor (Sanofi?), it makes sense you are completing the 1571 form. It is the Sponsor's responsibility to do this. If my assumption is true, people there have done this before and I've been at their Paris headquarters in meetings with other regulatory leaders there who are experienced at this, perhaps from other divisions. Ask around. For almost all products heading towards initial clinical trials, it behooves you to prepare for and hold a pre-IND meeting with FDA to discuss the regulatory pathway(s) and requirements you may face to proceed with clinical studies. If not already done, this could take months to prepare. But here you are, ready to file your IND.
First, FDA has an instruction page at
INSTRUCTIONS FOR FILLING OUT FORM FDA 1571www.fda.gov › media › download. Also be sure you are using the newest 1571 form that you can upload directly from FDA at
FORM FDA 1571www.fda.gov › media › download. The instructions will address every Field. But your questions are great and here is a quick reply:
1) For the indication in Field 7, this is not "study phase" specific. Insert the medical indication that is the target (i.e., disease) of the therapeutic/vaccine product. This allows FDA to forward the application to the correct reviewing division. (You can have more than one indication for the same product/IND, but one is enough to start. If you expect your product will have diverse disease indications, it is likely multiple INDs will be needed eventually, as they might be handled separately by different reviewing divisions. These things you discuss with FDA once your first indication is established.) Saying "healthy volunteers" alone is not useful for this, even for a vaccine that will eventually be used in healthy individuals. There is a Field 7B on the current form to put your indication into a standardized SNOMED category.
2) For Field 16, the name of person here need not be an MD. It could, for example, be the director or manager of the CRO doing the monitoring, or a person in a similar leadership role within the Sponsoring company who may or may not be an MD.
3) For Field 17, this is expected to be someone with adequate medical training to evaluate safety issues and therefore an MD (or equivalent, like MBBS) is expected. It would be very hard to defend not naming a medically-qualified person (i.e., a licensed practitioner as we say in the U.S.) in this role. It should be someone very familiar with the disease indication (a medical specialist) as well as the class of product being evaluated.
4) Who is taking on the responsibilities of the IND as the Sponsoring organization is to be listed at Field 18. For a commercial (Pharma) company Sponsor, the named person is usually dictated by the organization's legal or internal structure, typically someone at the Director or VP level related to Regulatory Affairs, or as FDA says, "the sponsor's authorizing representative." They are committing the company to legal obligations, so it must not taken on by anyone without proper authorization. It is fairly common for a Pharma Sponsor to hire a CRO or other entity and authorize them to take on some-or even all-of the obligations of an IND (see 21 CFR 312.52). This can include signing IND submission documents like the 1571 (see Field 15 instructions). But if that transfer of regulatory obligations (TORO) is to take place, it must first be designated in writing and signed by that Pharma corporate officer or "authorizing representative." A copy of that TORO authorization document, with the specifics of what elements of responsibility are being transferred, would be included in the IND submission, so the chain of responsibilities is clear to FDA. Some Sponsors (and CROs) have TORO checklists to clearly designate which specific responsibilities are being transferred in their agreements, though in the long run, the Pharma Sponsor still has ultimate legal responsibilities. If signing FDA forms and submissions is part of the TORO agreement for the CRO, that "authorized representative" can be named at Field 17 and sign the 1571 at Field 27. It is perhaps more common for Pharma Sponsors to transfer virtually all other IND responsibilities
except the signing of the 1571 forms. Perhaps this is a way of making the Sponsor review the materials prepared for them by the CRO, thus at least appearing to exercise some of the oversight they should have over their contractors.
Hope that helps!
Bonne chance!
Jan
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Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
Consultant
United States
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Original Message:
Sent: 26-Jan-2021 05:04
From: Nathalie DELESQUE TOUCHARD
Subject: FDA Form 1571
Dear community,
I need to fill out form 1571 for an upcoming IND submission and this is the first time. The IND will be a sponsor IND (pharma company).
I have a few (surely naive) questions:
- For a phase 1, should we indicate an indication in field 7 (Phase 1 with healthy volunteers) ?
- Field 16, we have to provide the "Name and Title of the person responsible for monitoring the conduct and progress of the clinical investigations". Does this person have to be a MD ?
- Field 17, we have to provide the "Name and Title of the person responsible for review and evaluation of information relevant to the safety of the drug". Does this person have to be a MD ?
- Field 18, we have to provide the "Name of Sponsor or Sponsor's Authorized Representative". We want to name someone but do you have any recommendations for choosing the most appropriate person to be appointed ? A scientist ? A regulatory ? other ?
Thank you very much for your precious help.
Nathalie, PhD
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Nathalie DELESQUE TOUCHARD
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