Section
|
Title of recommendation
|
Format |
Share person table in CDISC or OMOP format |
Group data and data elements into relevant data domains (e.g., medication history, laboratory results history, medical procedure history) |
Follow a convention when using relative time. |
Utilize previously defined Common Data Elements and reference them by their identifiers |
Use formats that can be natively loaded (without highly specialized add-ons) into multiple statistical platforms |
Data Sharing |
Register your study at ClinicalTrials.gov registry |
Do not limit study metadata to the legally required elements. Also populate optional elements (such as data sharing metadata) |
Fully populate data_sharing_plan text filed on ClinicalTrials.gov (if sharing data) |
If Individual Participant Data is shared on a data sharing platform, update the ClinicalTrials.gov record with the URL link to the data. |
Provide basic summary results using results registry component of Clinicaltrials.gov |
Utilize ClinicalTrials.gov fields for uploading study protocol, empty case report forms, statistical analysis plan and study URL link |
Provide de-identified Individual Participant Data |
Study Design |
Adopt previously defined applicable Common Data Elements |
Case Report Forms |
Share all Case Report Forms used in a study |
List all CRFs |
Data Dictionary |
Provide data dictionary |
Provide data dictionary in machine readable format |
Separate data dictionary from de-identified individual participant data. Since it contains no participant level data, do not require local ethical approval as a condition of releasing the data dictionary (avoid a requestwall for data dictionary). |
Share a data dictionary as soon as possible. Do not wait until the data collection is complete. |
Provide data dictionary in a single, machine-readable file. |
For each data element, provide a data type (such as numeric, date, string, categorical) |
For categorical data elements, provide a list of permissible values and distinguish when numerical code or string code is a code for a permissible value (versus actual number or string) |
Distinguish categorical string data elements from free-text string data elements |
Link utilized Common Data Elements adopted by your study to appropriate terminologies |
Link data elements or permissible values to applicable routine healthcare terminologies (either because you designed them to be linked or post-hoc, they can be semantically linked as equivalent) |
Provide complete data dictionary (all elements in data are listed in a dictionary) and all types of applicable dictionaries (date elements, forms [or groupings], and permissible values) |
Include sufficient description for data elements |
Use identifiers (unique where applicable) for data element, forms and permissible values. |
Data de-identification |
Provide data de-identification notes |
Choice of a Data Sharing platform |
Use platforms that allows download of all studies available on the platform |
Choose a platform that supports batch request (ability to request multiple studies with one request) |