Data Availability

How to answer

Not all HEAL studies collect or produce data. Some develop methods and protocols for future studies. If your study will NOT collect or produce data, but will produce shareable products other than data (e.g. protocols, slide decks, etc.), answer “No.”

How this field will be used

This field allows Platform users to filter between studies that will collect or produce data, and those that will not.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?”

Answers include:

None: If you do not plan to make any study data available in a HEAL approved repository, select “None.” While most HEAL studies are obligated to share data, select HEAL studies, such as SBIR grants, are not.

Some: If you plan to make some, but not all, study data available, select “Some.” For example, you may plan to share data needed to reproduce publications, processed data files, or extensively de-identified data, but exclude certain datasets or sources (such as administrative data, when your data sharing agreement does not allow sharing).

All: If you plan to make study data available to the greatest extent possible (e.g. sharing nearly raw clinical trial data in a data repository, subject to very strong access controls, including some data that may be very useful for analysis but pose a risk of re-identification, such as highly granular geographic information, detailed diagnostic and care provision, utilization patterns, and/or clinician notes), select “All.”

How this field will be used

This field will allow users to filter between studies that will share data, and those that will not. Users who are interested in accessing datasets that include highly sensitive variables that present re-identification risks (e.g. geographic variables with high granularity) may want to filter down to studies that plan to share “All” data, as this will filter out studies that plan to share only extensively de-identified data.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?” AND you answered “Some” or “All” to “Will the study make data available?”

Answers include

None: If all your repository-hosted study data will be open access or minimally restricted (i.e. available after signing a minimal DUA that does not require any manual intervention or approval).

Some: If some of your repository-hosted study data will be open access or minimally restricted, while other data will be available only after a request and approval process that does require substantial manual intervention (e.g. submission of a project proposal and IRB approval by the requestor; review by a Data Access Committee on the repository end; etc.). For example, a clinical trial may choose this option when sharing 1) an extensively de-identified dataset that is open access/minimal access controls, AND 2) a less de-identified dataset, shared under strict access controls, that includes features which add value for some analysis questions but also present substantial risk for re-identification.

All: If all your repository-hosted study data will be available only following a request and approval process requiring substantial manual intervention (e.g. submission of a project proposal and IRB approval by the requestor; review by a Data Access Committee on the repository end; etc.). For example, a clinical trial may choose this option when ONLY sharing a less de-identified dataset that includes features which add value for some analysis questions, but also present substantial risk for re-identification, shared under strict access controls. These studies WILL NOT share a extensively de-identified version of the data as open access/minimal access controls.

How this field will be used

This field will allow users looking for data they may be able to access quickly and easily to filter for studies sharing some, or all, of their data as open access/minimal access controls.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?”

Answers include:

• Not started: If your study, including studies with multiple parts/aims, has not started collecting ANY data.
• Started: If your study, including studies with multiple parts/aims, started collecting ANY data.
• Finished: If your study, including studies with multiple parts/aims, finished collecting ALL data.

This field should be updated as a HEAL study moves through its life-cycle - see information on how to update.

How this field will be used

This field allows users to filter studies that are at different stages of data collection. Filtering for later stage data collection (e.g. “Started” or “Finished”) helps users find studies that may soon have data available. This field will also allow users more interested in study findings/results than data, to find studies where a publication with findings/results may be available or expected soon.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?” AND you answered “Some” or “All” to “Will the study make data available?”

Answers include:

• Not started: if your study, including studies with multiple parts/aims, has not started making ANY study data available in a repository for long-term data sharing.
• Started: if your study, including studies with multiple parts/aims, started making ANY study data available in a repository for long-term data sharing, but is not finished (i.e. will share more data later).
• Finished: if your study, including studies with multiple parts/aims, finished making ALL study data available in a repository for long-term data sharing (i.e. no further data to share).

This field should be updated as a HEAL study moves through its life-cycle - see information on how to update.

How this field will be used

This field allows users to filter studies at different stages of data release. Filtering for later stage data release (e.g. “Started” or “Finished”) helps users find studies that already have data available. This field will also allow users more interested in study findings/results than data, to find studies where a publication with findings/results may be available or expected soon.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?”

This is a date field that allows you to input a date. If data collection has not started, provide the anticipated date on which data collection will start. If data collection has started, provide the date data collection actually started.

See here for guidance on filling out a CEDAR date field

Values in this field are validated as MM/DD/YYYY and will not be accepted if improperly formatted

Dates should be updated if they change - see information on how to update.

How this field will be used

Platform users can view the data collection start date on each study’s Platform study page page, allowing interested users to understand study timing, and when to expect data or publications/findings.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?”

This is a date field that allows you to input a date. If data collection has not ended, provide the anticipated date on which data collection will end. If data collection has ended, provide the date data collection actually ended.

See here for guidance on filling out a CEDAR date field

Values in this field are validated as MM/DD/YYYY and will not be accepted if improperly formatted

Dates should be updated if they change - see information on how to update.

How this field will be used

Platform users can view the data collection completion date on each study’s Platform study page page, allowing interested users to understand study timing, and when to expect data or publications/findings.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?” AND if you ALSO answered “Some” or “All” to “Will the study make data available?”)

This is a date field that allows you to input a date. If data release has not started, provide the anticipated date on which data release will start. If data release has started, provide the date data release actually started.

See here for guidance on filling out a CEDAR date field

Values in this field are validated as MM/DD/YYYY and will not be accepted if improperly formatted

Dates should be updated if they change - see information on how to update.

How this field will be used

Platform users can view the data release start date on each study’s Platform study page page, allowing interested users to understand study timing, and when to expect data or publications/findings.

How to answer

This field ONLY APPLIES if you answered “Yes” to “Will the study collect or produce data?” AND if you ALSO answered “Some” or “All” to “Will the study make data available?”)

This is a date field that allows you to input a date. If data release has not ended, provide the anticipated date on which data release will end. If data release has ended, provide the date data release actually ended.

See here for guidance on filling out a CEDAR date field

Values in this field are validated as MM/DD/YYYY and will not be accepted if improperly formatted

Dates should be updated if they change - see information on how to update.

How this field will be used

Platform users can view the data release completion date on each study’s Platform study page page, allowing interested users to understand study timing, and when to expect data or publications/findings.

How to answer

If your study will produce shareable products other than data (e.g. protocols, slide decks, data dictionaries, etc.), answer “Yes.”

How this field will be used

Some HEAL studies do “pre-work” for other HEAL studies (e.g. protocol development) and do not collect data. Others (i.e. small business grant studies) are not obligated to share data. This field enables Platform Users 1) looking for non-data materials such as protocols, and/or 2) interested in learning about studies that will not share data (such as small business grant studies), to explore contacting study leads to develop a collaborative relationship that may provide access to the data via a non-public forum.