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application/vnd.openxmlformats-officedocument.presentationml.presentation
PowerPoint Presentation
Erin Luetkemeier
Impress
2016-02-19
2026-08-24
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Attachment 1: Documentation of the dbGaP
registration system, including changes since 2013 PRA
approval

Study Registration Web Forms

Public reporting burden for this collection of information is estimated to vary from 30 to 60 minutes per response for initial
registration of the required fields. An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx). Do not return the
completed form to this address.

New categorization of data types
for ease of completion and greater
consistency among submissions.

New section for inclusion of PI
assistant contact information, so
all correspondence do not have to
go through the PI.

Deletion of additional questions
on publication embargo because it
is no longer applicable.

Added ability to auto-create the
DUC from existing information in
the submission package.

New fillable PDF for the
submission certifications (slides 67).

New fillable PDF for the
submission certifications.

New standard data use limitations
as part of the fillable PDF.

Categories for consent groups now
provided in lieu of free text box
for ease of completion and greater
consistency among submissions.
Data Use Limitations are
autopopulated based on the
consent groups selected.