The FDA Form 1572 is an agreement, signed by the investigator, to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of of a a clinical investigation of of an an investigational drug or biologic. The sponsor of of the the project is required to collect the 1572 from the investigator at each site. Investigators and sponsors are not required to submit 1572’s to the FDA, or to the University for the IRB files. The 1572’s are kept by the sponsors, who use the form to submit information to the FDA. Although they are not required to file the 1572 with the IRB, some PI’s do send in a copy of of the the form to the University. If If that that happened, those forms would be in the project file. The project you have requested is an old one from around 2000. I will let you know as soon as we have more information for you. Sincerely, Susan Susan McKinney, CRM Minnesota Government Data Practices Act Responsible Authority Director, Records & Information Management 502 Morrill Hall 100 Church Street SE Campus Mail Code 0263D Minneapolis, MN 55455 (612) 625‐3497
[email protected] From: Carl Elliott [mailto:
[email protected] [mailto:
[email protected]]] Sent: Friday, February 22, 2013 3:44 PM To: 'Susan Mc Kinney' Subject: RE: data practice act request
A ctually, they’re they’re not not that old. old. Seroquel Seroquel XR X R was was approved in 200 2007. 7. Those1572s are requi required red by the FDA. DA . Why wouldn’t the they y be in the the IRB IRB databa tabase? Carl From: Susan Mc Kinney [mailto:
[email protected] [mailto:
[email protected]]] Sent: Friday, February 22, 2013 2:57 PM To: Carl Elliott Cc:
[email protected] Subject: RE: data practice act request
We are looking for the files in the IRB. These are very old files that are not in the database, so it is taking some time to find them. Sorry for the delay. Susan
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Susan McKinney, CRM Minnesota Government Data Practices Act Responsible Authority Director, Records & Information Management 502 Morrill Hall 100 Church Street SE Campus Mail Code 0263D Minneapolis, MN 55455 (612) 625‐3497
[email protected] From: Carl Elliott [mailto:
[email protected] [mailto:
[email protected]]] Sent: Friday, February 22, 2013 2:54 PM To: 'Susan Mc Kinney' Subject: RE: data practice act request
Ms. McKinn cK inne ey, Sorry to be apest (again), but coul could you let let me know the status of my DPA DPA request of Feb. 9th? Tha Thanks Carl Elliott
From: Susan Mc Kinney [mailto:
[email protected] [mailto:
[email protected]]] Sent: Tuesday, February 12, 2013 1:10 PM To: Carl Elliott Subject: RE: data practice act request
I received your request. We currently have quite a few requests ahead of of yours, yours, but will hopefully get to it soon. Susan Susan McKinney, CRM Minnesota Government Data Practices Act Responsible Authority Director, Records & Information Management 502 Morrill Hall 100 Church Street SE Campus Mail Code 0263D Minneapolis, MN 55455 (612) 625‐3497
[email protected]
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Dear Ms. Ms. McKi McK inney: I did did not get an acknowl acknowled edge of my Dat Data a Practice Practice Reque Request for the Forms orms 1572s 1572s for Drs Drs Olson Ol son and Schul Schulz and I wante wanted d to make sure you received it. Could ould you pl please let me know if it arri arrived ved? ? Tha Thanks, Carl Elliott
