Working groups are currently formed to review five clinical research study domains:
- Physical Examination/Medical History;
- Cardiopulmonary and Renal Function;
- Outcomes; and
- Monitoring Side Effects.
These groups are comprised of SCD adult and pediatric specialists, patient advocates, genetic therapy specialists, neuropsychologists, nurses, data managers, manufacturers, industry members and academics. Members of each group will meet over a period of six months and then on an ad hoc as needed to complete the process. Over the six months the group members will systematically review the data forms, discuss the form content and vote until a consensus regarding the form content is reached. The product of the working group will then be reviewed by the CTD Subcommittee before posting the forms for Public Review on the CureSCi website (curesickle.org). After a Public Review period and follow-up with working groups, version 1.0 of the standardized data forms will be released to the CureSCi web site. The forms will also be made available through the National Library of Medicine (NLM) website (https://cde.nlm.nih.gov/). This will be an iterative process and feedback from users will be encouraged.
The current recommendations are Proposed (Version 0.0) data standards.