The National Heart, Lung and Blood Institute (NHLBI) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. The Cure Sickle Cell Initiative (CureSCi) has assembled a set of common data elements (CDEs) to facilitate the collection of data on clinical research studies of gene therapies for sickle cell disease.

The first set of CDEs for Sickle Cell Disease (SCD) gene therapy studies were finalized in 2021. The Core data elements to be used by an investigator when beginning a research study in this disease/disorder are listed in the Start-up Resource Listing document.

The goals of the NHLBI CureSCi CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.

The data standards are organized by domains and sub-domains, often used in clinical studies, data standards include:

• CDEs — Classified as Core, Supplemental - Highly Recommended, Supplemental, or Exploratory

• CRF Modules — Logically organize CDEs for data collection

• Guidelines — Provide further information about the CDEs

An overview of all Sickle Cell Disease Genetic CDE recommendations can be found in the  CureSCi CDE Highlight Summary document .

CureSCi CDEs are available on the National Institute of Health Common Data Elements Repository.

Metadata Catalog

The NHLBI Cure Sickle Cell Initiative has established a web-based publicly available Metadata Catalog of curated data elements and study documentation from past and current studies of sickle cell disease populations. The catalog has data variables from 31 studies organized into searchable categories. Tools to help investigators find data elements and determine the availability of common data for cross-study analysis are provided.