Purpose of this best practice: When data is shared, an archival “data package” should be maintained for retrieval/review at a later point in time.
Positions and Responsibilities
- Principal Investigator (PI): The Principal Investigator is responsible for data related to their study and is ultimately responsible for ensuring that shared data is archived and documented.
- Data Manager (DM): The Data Manager is responsible for maintaining the integrity of the data that is to be archived.
- Data Analyst/Biostatistician: The Data Analyst/Biostatistician may need to keep track of exactly what data is shared, and to keep the documentation and metadata up-to-date in order to serve as an appropriate reference over time.
Best Practices
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All items associated with shared data should be "packaged" and archived in a secure location. This package should include items such as:
1.1. Data File
1.2. Data Dictionary / Code Book
1.3. Sharing Agreements
1.4. Inclusion/Exclusion Criteria
1.5. Blank sample of Consent Form
1.6. Distribution Details (who shared it, when it was shared, who it was shared with, how it was distributed)
1.4. Inclusion/Exclusion Criteria
1.5. Blank sample of Consent Form
1.6. Distribution Details (who shared it, when it was shared, who it was shared with, how it was distributed)
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Other Considerations for Distribution
2.1. The documentation should be easily understandable by anyone using the data.
2.2. Should indicate the date on which the data package was shared.
2.3. It is recommended that any completed research project or data associated with a publication should be packaged and archived for the study’s own use.
Useful Links:
JHU Data Services - Data Sharing and Reproducible Research