Here are a few examples of activities and groups using common data elements at NIH. Some CDEs are developed into collections that cross disciplines and domains, such as NIH Toolbox, PhenX Toolkit, PROMIS and Neuro-QoL. Some are domain or disease focused, such as the NINDS Common Data Elements (Neurology), eyeGENE (ophthalmic disease), and the National Heart, Lung and Blood Institute (NHLBI) Cure Sickle Cell Initiative.

While CDEs may be new to some, several collections have been established for years in their communities. One example is the National Cancer Institute (NCI), which has been promoting CDEs for over 20 years.

Let’s take a closer look at two collections: NHLBI Cure Sickle Cell Initiative and PhenX.

NHLBI Cure Sickle Cell Initiative

The NHLBI Cure Sickle Cell Initiative has developed a set of CDEs “to facilitate the collection of data on clinical research studies of genetic therapies for sickle cell disease,” with the goal of making research more efficient, open, and rapid to help identify, treat, and reduce sickle cell disease.

The NHLBI Cure Sickle Cell Initiative Data Standards include a list of domains and subdomains to narrow in on specific topics. Domains include:

• Participant Characteristics
• Disease or Treatment Related Events
• Assessments and Examinations
• Treatment/Intervention Data
• Safety Data
• Outcomes and End Points
• Additional Proposed Instruments

These CDEs can also be found in the NIH Common Data Element Repository CDEs > NHLBI > Sickle Cell Disease. Note: As of this writing, the Sickle Cell CDEs in the Repository have not yet been endorsed by the NIH CDE Governance Committee, but the Cure Sickle Cell team has begun the submission process.