This file list includes the ADSD V1.0 files for FDA Review.

  File Modified
Microsoft Word Document CDISC QRS Review Request ADSD V1.0 2021-04-07.docx Apr 06, 2021 by Steve Kopko
PDF File ADSD Annotated CRF.pdf Apr 06, 2021 by Steve Kopko
Microsoft Word Document SDTM QS-ADSD V1.0 Approved.docx Apr 06, 2021 by Steve Kopko
PDF File PROC_ADSD_ANSD_UserManuaReleasedV1_20190330.pdf Apr 06, 2021 by Steve Kopko
Microsoft Word Document CDISC QRS 2nd Review Request ADSD V1.0 2021-05-24.docx May 24, 2021 by Steve Kopko
Microsoft Word Document SDTM QS-ADSD V1.0 Approved 2021-05-24.docx May 24, 2021 by Steve Kopko
Microsoft Word Document CDISC QRS 3rd Review Request ADSD V1.0 2021-12-08.docx Dec 28, 2021 by Steve Kopko
Microsoft Word Document SDTM QS-ADSD V1.0 Approved 2021-12-08.docx Dec 28, 2021 by Steve Kopko
Microsoft Word Document ADSD changes since 2021-05-24 version.docx Dec 28, 2021 by Steve Kopko
PDF File QRS EMAIL-CDISC QRS 3rd Review Request ADSD V1.0 2021-12-08.pdf Dec 29, 2021 by Steve Kopko
Microsoft Word Document FDA_Response_CDISC_3rd_FDA_Review_Request_ADSD_V1.0_2021-12-08.docx Feb 15, 2023 by Steve Kopko
Microsoft Word Document 2021-12-08 Supp_V1.0_SDTM QS-ADSD-V1.0_FDA_Comments.docx Feb 15, 2023 by Steve Kopko

This file list includes the ADSD V1.0 files for FDA Review.

  File Modified
Microsoft Word Document CDISC QRS Review Request ADSD V1.0 2021-04-07.docx Apr 06, 2021 by Steve Kopko
PDF File ADSD Annotated CRF.pdf Apr 06, 2021 by Steve Kopko
Microsoft Word Document SDTM QS-ADSD V1.0 Approved.docx Apr 06, 2021 by Steve Kopko
PDF File PROC_ADSD_ANSD_UserManuaReleasedV1_20190330.pdf Apr 06, 2021 by Steve Kopko
Microsoft Word Document CDISC QRS 2nd Review Request ADSD V1.0 2021-05-24.docx May 24, 2021 by Steve Kopko
Microsoft Word Document SDTM QS-ADSD V1.0 Approved 2021-05-24.docx May 24, 2021 by Steve Kopko
Microsoft Word Document CDISC QRS 3rd Review Request ADSD V1.0 2021-12-08.docx Dec 28, 2021 by Steve Kopko
Microsoft Word Document SDTM QS-ADSD V1.0 Approved 2021-12-08.docx Dec 28, 2021 by Steve Kopko
Microsoft Word Document ADSD changes since 2021-05-24 version.docx Dec 28, 2021 by Steve Kopko
PDF File QRS EMAIL-CDISC QRS 3rd Review Request ADSD V1.0 2021-12-08.pdf Dec 29, 2021 by Steve Kopko
Microsoft Word Document FDA_Response_CDISC_3rd_FDA_Review_Request_ADSD_V1.0_2021-12-08.docx Feb 15, 2023 by Steve Kopko
Microsoft Word Document 2021-12-08 Supp_V1.0_SDTM QS-ADSD-V1.0_FDA_Comments.docx Feb 15, 2023 by Steve Kopko