Data Management

• Adequate data to validate and replicate study findings
• Data resulting from the study but not necessarily supporting a publication
• Null findings that do not result in publication

Related tools, software, code

• Specialized tools that are needed to access the shared data
• Names of specific software tools (e.g. Python, SPSS, etc.)
• Availability of tools (e.g. open source vs purchase
• Expected lifespan of the tools compared to length of data availability

• Laboratory notebooks
• Preliminary analyses
• Completed case report forms
• Drafts of scientific papers
• Plans for future research
• Peer reviews
• Communications with colleagues
• Physical objects, such as laboratory specimens

• Informed consent limitations on sharing
• Existing consent (e.g., for previously collected biospecimens) prohibits sharing
• Privacy or safety of research participants would be compromised or place them at greater risk of re-identification or suffering harm
• Explicit federal, state, local or Tribal law, regulation, or policy prohibits disclosure
• Datasets cannot practically be digitized with reasonable effort

• Data formats
• Data dictionaries
• Common Data Elements
• Identifiers
• Definitions
• Indicate when no consensus standard exists

• Name of repository (ies) where data will be shared
• Findability and identifiability of data (e.g. unique identifiers)
• When data will be shared
  • No later than time of publication or end of performance period
  • How long data is anticipated to be available

• HOW compliance with Data Management and Sharing Plan will be monitoring and managed
• WHO will be responsible for oversight
• HOW OFTEN will oversight activities occur