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. 2021 May 17;2021:438–444.

Table 1. Individual CONSIDER recommendations by section.

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)