Collection - General Tab
Fields available for edit on the top portion of the page include:
- Collection Title
- Investigators
- Collection Description
- Collection Phase
- Funding Source
- Clinical Trials
Collection Phase: The current status of a research project submitting data to an
NDA Collection, based on the timing of the award and/or the data that have been submitted.
- Pre-Enrollment: The default entry made when the NDA Collection is created.
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Enrolling: Data have been submitted to the NDA Collection or the NDA Data Expected initial submission
date has been reached for at least one data structure category in the NDA Collection.
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Data Analysis: Subject level data collection for the research project is completed and has been submitted
to the NDA Collection. The NDA Collection owner or the NDA Help Desk may set this phase when they’ve confirmed data submission is complete and submitted subject counts match at least 90% of the target enrollment numbers in the NDA Data Expected. Data submission reminders will be turned off for the NDA Collection.
- Funding Completed: The NIH grant award (or awards) associated with the NDA Collection has reached its end
date. NDA Collections in Funding Completed phase are assigned a subphase to indicate the status of data
submission.
- The Data Expected Subphase indicates that NDA expects more data will be submitted
- The Closeout Subphase indicates the data submission is complete.
- The Sharing Not Met Subphase indicates that data submission was not completed as expected.
Blinded Clinical Trial Status:
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This status is set by a Collection Owner and indicates the research project is a double blinded clinical
trial. When selected, the public view of Data Expected will show the Data Expected items and the
Submission Dates, but the targeted enrollment and subjects submitted counts will not be displayed.
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Targeted enrollment and subjects submitted counts are visible only to NDA Administrators and to the NDA
Collection or as the NDA Collection Owner.
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When an NDA Collection that is flagged Blinded Clinical Trial reaches the maximum data sharing date for
that Data Repository (see
https://nda.nih.gov/nda/sharing-regimen.html), the embargo on
Data Expected information is released.
Funding Source
The organization(s) responsible for providing the funding is listed here.
Supporting Documentation
Users with Submission privileges, as well as Collection Owners, Program Officers, and those with
Administrator privileges, may upload and attach supporting documentation. By default, supporting
documentation is shared to the general public, however, the option is also available to limit this
information to qualified researchers only.
Grant Information
Identifiable details are displayed about the Project of which the Collection was derived from. You may
click in the Project Number to view a full report of the Project captured by the NIH.
Clinical Trials
Any data that is collected to support or further the research of clinical studies will be available here.
Collection Owners and those with Administrator privileges may add new clinical trials.
Frequently Asked Questions
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How does the NIMH Data Archive (NDA) determine which Permission Group data are submitted into?
During Collection creation, NDA staff determine the appropriate Permission Group based on the type of data to be submitted, the type of access that will be available to data access users, and the information provided by the Program Officer during grant award.
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How do I know when a NDA Collection has been created?
When a Collection is created by NDA staff, an email notification will automatically be sent to the PI(s) of the
grant(s) associated with the Collection to notify them.
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Is a single grant number ever associated with more than one Collection?
The NDA system does not allow for a single grant to be associated with more than one Collection; therefore, a single grant will not be listed in the Grant Information section of a Collection for more than one Collection.
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Why is there sometimes more than one grant included in a Collection?
In general, each Collection is associated with only one grant; however, multiple grants may be associated if
the grant has multiple competing segments for the same grant number or if multiple different grants are all
working on the same project and it makes sense to hold the data in one Collection
(e.g., Cooperative Agreements).
Glossary
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Administrator Privilege
A privilege provided to a user associated with an NDA Collection or NDA Study whereby that user can perform a
full range of actions including providing privileges to other users.
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Collection Owner
Generally, the Collection Owner is the contact PI listed on a grant. Only one NDA user is listed as the Collection owner. Most automated emails are primarily sent to the Collection Owner.
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Collection Phase
The Collection Phase provides information on data submission as opposed to grant/project completion so while the Collection phase and grant/project phase may be closely related they are often different. Collection users with Administrative Privileges are encouraged to edit the Collection Phase. The Program Officer as listed in eRA (for NIH funded grants) may also edit this field. Changes must be saved by clicking the Save button at the bottom of the page. This field is sortable alphabetically in ascending or descending order. Collection Phase options include:
- Pre-Enrollment: A grant/project has started, but has not yet enrolled subjects.
- Enrolling: A grant/project has begun enrolling subjects. Data submission is likely ongoing at this point.
- Data Analysis: A grant/project has completed enrolling subjects and has completed all data submissions.
- Funding Completed: A grant/project has reached the project end date.
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Collection Title
An editable field with the title of the Collection, which is often the title of the grant associated with the Collection.
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Supporting Documentation
Various documents and materials to enable efficient use of the data by investigators unfamiliar with the project and may include the research protocol, questionnaires, and study manuals.
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NIH Research Initiative
NDA Collections may be organized by scientific similarity into NIH Research Initiatives, to facilitate query
tool user experience. NIH Research Initiatives map to one or multiple Funding Opportunity Announcements.
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Permission Group
Access to shared record-level data in NDA is provisioned at the level of a Permission Group. NDA Permission
Groups consist of one or multiple NDA Collections that contain data with the same subject consents.
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Planned Enrollment
Number of human subject participants to be enrolled in an NIH-funded clinical research study. The data is provided in competing applications and annual progress reports.
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Actual Enrollment
Number of human subjects enrolled in an NIH-funded clinical research study. The data is provided in annual progress reports.
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NDA Collection
A virtual container and organization structure for data and associated documentation from one grant or one
large project/consortium. It contains tools for tracking data submission and allows investigators to define a
wide array of other elements that provide context for the data, including all general information regarding the
data and source project, experimental parameters used to collect any event-based data contained in the
Collection, methods, and other supporting documentation. They also allow investigators to link underlying data
to an NDA Study, defining populations and subpopulations specific to research aims.
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Data Use Limitations
Data Use Limitations (DULs) describe the appropriate secondary use of a dataset and are based on the original
informed consent of a research participant. NDA only accepts consent-based data use limitations defined by
the NIH Office of Science Policy.
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Total Subjects Shared
The total number of unique subjects for whom data have been shared and are available for users with permission to access data.