Working groups were formed to review five clinical research study domains:
- Physical Examination/Medical History;
- Cardiopulmonary, Renal and Cerebrovascular;
- Outcomes; and
- Monitoring Side Effects.
These working groups are comprised of SCD adult and pediatric specialists, patient advocates, genetic therapy specialists, neuropsychologists, nurses, data managers, manufacturers, industry members, and academics. After this Public Review period and follow-up with working groups, version 1.0 of the standardized data forms will be released here on the CureSCi website. The forms will also be made available through the National Library of Medicine (NLM) website. This will be an iterative process, and feedback from users will be encouraged.
The current recommendations are Proposed (version 0.0) data standards.