TheFDAForm1572isanagreement,signedbytheinvestigator,toprovidecertaininformationtothe sponsorandassurethathe/shewillcomplywithFDAregulationsrelatedtotheconductofaclinical investigationofaninvestigationaldrugorbiologic.Thesponsoroftheprojectisrequiredtocollectthe 1572fromtheinvestigatorateachsite.Investigatorsandsponsorsarenotrequiredtosubmit1572sto theFDA,ortotheUniversityfortheIRBfiles.The1572sarekeptbythesponsors,whousetheformto submitinformationtotheFDA. Althoughtheyarenotrequiredtofilethe1572withtheIRB,somePIsdosendinacopyoftheformto theUniversity.Ifthathappened,thoseformswouldbeintheprojectfile.Theprojectyouhave requestedisanoldonefromaround2000.Iwillletyouknowassoonaswehavemoreinformationfor you.

. Sincerely, Susan SusanMcKinney,CRM MinnesotaGovernmentDataPracticesActResponsibleAuthority Director,Records&InformationManagement 502MorrillHall 100ChurchStreetSE CampusMailCode0263D Minneapolis,MN55455 (612)6253497 mckin018@umn.edu
From: Carl Elliott [mailto:ellio023@gmail.com] Sent: Friday, February 22, 2013 3:44 PM To: 'Susan Mc Kinney' Subject: RE: data practice act request

Actually, theyre not that old. Seroquel XR was approved in 2007. Those 1572s are required by the FDA. Why wouldnt they be in the IRB database? Carl
From: Susan Mc Kinney [mailto:mckin018@umn.edu] Sent: Friday, February 22, 2013 2:57 PM To: Carl Elliott Cc: mckin018@umn.edu Subject: RE: data practice act request

WearelookingforthefilesintheIRB.Theseareveryoldfilesthatarenotinthedatabase,soitistaking sometimetofindthem. Sorryforthedelay. Susan

SusanMcKinney,CRM MinnesotaGovernmentDataPracticesActResponsibleAuthority Director,Records&InformationManagement 502MorrillHall 100ChurchStreetSE CampusMailCode0263D Minneapolis,MN55455 (612)6253497 mckin018@umn.edu

From: Carl Elliott [mailto:ellio023@gmail.com] Sent: Friday, February 22, 2013 2:54 PM To: 'Susan Mc Kinney' Subject: RE: data practice act request

Ms. McKinney, Sorry to be a pest (again), but could you let me know the status of my DPA request of Feb. 9th? Thanks Carl Elliott
From: Susan Mc Kinney [mailto:mckin018@umn.edu] Sent: Tuesday, February 12, 2013 1:10 PM To: Carl Elliott Subject: RE: data practice act request

Ireceivedyourrequest.Wecurrentlyhavequiteafewrequestsaheadofyours,butwillhopefullygetto itsoon. Susan SusanMcKinney,CRM MinnesotaGovernmentDataPracticesActResponsibleAuthority Director,Records&InformationManagement 502MorrillHall 100ChurchStreetSE CampusMailCode0263D Minneapolis,MN55455 (612)6253497 mckin018@umn.edu
From: Carl Elliott [mailto:ellio023@gmail.com] Sent: Tuesday, February 12, 2013 9:55 AM To: mckin018@umn.edu Cc: ellio023@gmail.com Subject: data practice act request

Dear Ms. McKinney: I did not get an acknowledge of my Data Practice Request for the Forms 1572s for Drs Olson and Schulz and I wanted to make sure you received it. Could you please let me know if it arrived? Thanks, Carl Elliott