Setting Up Data Expected
NDA's Data Expected is the list of all data structures in which data will be collected and submitted for a given collection as well as targeted enrollment numbers, initial submission, and initial sharing dates for each structure
Investigators will define their new Collection's "Data Expected" section within 6 months of grant award. Within the Data Expected tab of the Collection, create a data dictionary request by selecting existing or new data structures. The NDA curation team will extend existing NDA data dictionary data structures (add variables, extend value ranges, or add aliases) or create new NDA data dictionary data structures, to ensure that all new data is harmonized to the NDA data dictionary.
Input targeted enrollment numbers for each data structure. This is the total number of subjects for whom data will be collected and submitted in that structure. When data is collected from a subject across multiple visits, that subject is counted once in the ‘targeted enrollment’ field.
Initial Submission and Initial Share dates should be populated according to the applicable NDA Data Sharing Terms and Conditions (Data Sharing Regimen). Any modifications to these will go through the approval processes outlined above.
|Data Submission Agreement||Exceptions to Data Submission|