Standardizing Data Collection Forms

The Cure Sickle Cell Initiative (CureSCi) is assembling a set of common data elements (CDEs) to facilitate the collection of data on clinical research studies of genetic therapies for sickle cell disease. The data elements will be made available through the CureSCi website together with an online case report form builder.  This tool will provide investigators the ability to build a set of standardized case report forms (CRFs) thereby reducing study start-up and improving the ability to share study outcomes across SCD studies. Investigators will be asked to use the CDEs and encouraged to use the template CRFs in their NHLBI funded clinical research, patient registries and other human subject research with the goal of standardizing data collection to enhance data analysis and sharing of data. The use of the CDEs and CRFs in non-NHLBI funded research will be encouraged. The initial set of CRFs and CDEs (Version 0.0) are based on existing National Institute of Health (NIH) data standards or NIH funded programs. They include information from Patient-Reported Outcomes Measurement Information System (PROMIS), Consensus measure for Phenotypes and Exposures (PhenX) and Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME).

Version 1.0 of CRFs and CDEs will come from recommendations from working groups lead by the CureSCi Clinical Trial Design (CTD) Subcommittee.  The working groups are tasked with designing a standardized set of forms for collecting data for genetic clinical research studies in sickle cell disease (SCD).

Working groups are currently formed to review five clinical research study domains:

  • Genetics/Assays;
  • 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.

Data Standards

Users can search all the data standard forms by domain and subdomain.

View Data Standards

CRF Library

Users can search the Library to find CRF modules and guidelines of interest.

View CRF Library

CDE Catalog

Users can search the Catalog to isolate a subset of the CDEs and to view and download details about the CDEs.

View CDE Catalog