What types of data are to be collected in the study and shared (e.g., genetic, physiological, clinical, medical history, etc.)?
Will the study include unique data that cannot be readily duplicated (e.g., large surveys that are too expensive to replicate; studies of unique populations, such as centenarians; studies conducted at unique times, such as a natural disaster; studies of rare phenomena, such as rare metabolic diseases; etc.)?
Will individual-level data or raw data also be shared, and if so, will the whole data set be shared?
Will aggregate data (e.g., summary statistics or tables) also be shared? Will the analytical methods used (tools and parameters) be defined?
What data quality control measures will be implemented?
What data documentation will be shared (e.g., metadata, descriptors, schema) so that others can understand and use the dataset and to prevent misuse, misinterpretation, or confusion?
What commonly accepted data standards or standardized vocabularies will be used to enable others to interpret the data and improve interoperability with other data systems?
What format will be used to encode the data? Will this format be consistent with extant, commonly used standards?
In addition to final research data, what other data will be available?
Will the general public have access to some or all of the data?
Will access to certain data or certain components of the data be restricted to qualified researchers in orderto address specific rules, laws, regulations or policies (e.g., IRBs, human subjects, informed consent, etc.)?
If data access is restricted, what are the justifications/criteria for restricting access (e.g., relevant laws [local, State, Federal, etc.], regulations, rules, institutional policies, IRB approvals, and consent documents)?
What will researchers who seek to obtain data need to do to comply with any data access restrictions?
Are there any limitations on release of data that may be considered “sensitive?”
What data sharing agreements will be necessary to appropriately restrict the transfer of protected, sensitive, or confidential data to others and to require that data be used only for research purposes?
Who will be operationally responsible for ensuring that no personally identifiable information is made available (e.g., principal investigator, independent curator)?
Will an existing database, data repository, data enclave, or archive be used to store and disseminate the data (e.g., dbGaP, National Database for Autism Research [NDAR]), and if so, are the policies and procedures in place that will enable others to access the data consistent with applicable NIH policies?
Will a new repository need to be developed, and if so, who/what will maintain the repository?
Will the data be distributed directly by an investigator to those who request it (e.g., through an electronic medium?)
What data, if any, will be shared prior to publication?
What data will be shared upon acceptance for publication?
If using a repository, when will data be submitted to the repository?
Will data from ongoing longitudinal studies be released in increments as data become available?
Will the timing of data sharing be specifically linked to other relevant policies concerning the timing of release of data (e.g., NIH GWAS policy, ClinicalTrials.gov, specific requirements in the funding opportunity announcement [FOA])?
How will data maintenance and access be ensured after the award ends?
Will there be support for continued sharing of data (e.g., through grant applications, administrative supplements, or other sources) or planned migration of data to another database, data repository, etc.?