QUALITY ASSURANCE SUBCOMMITTEE

Goal:  To ensure the quality of data necessary for valid, robust clinical trials.

The instruments used to collect data (case report forms, data entry programs) should undergo pilot testing prior to implementation to ensure accuracy, ease-of-use, and to identify potential sources of error. RAs are the end-users of case report forms (CRFs) and data entry software, and are intimately familiar with potential issues and problems that may arise in the course of their work. As such, they are in a unique position to pilot test and validate the instruments in a real-world environment.

Strategies

  • Members of the RA Quality Assurance Subcommittee test new forms and data entry programs as they are developed, using an appropriate number of actual institutional cases.
  • Items to be reviewed while testing CRFs may include:
    • appropriateness of possible responses
    • consistency in data coding
    • handling of missing data
    • clarity of instructions
  • Testing and validation of data entry programs could encompass:
    • compatibility of the CRF with the data entry screen
    • suitability of skip patterns
    • edit checks and error messages
    • ability to make corrections
    • appropriateness of data entry tools (e.g.,  list boxes, combo boxes, option buttons
    • Standardized evaluation forms are completed during the testing process.
    • Results of testing are forwarded to the ACRIN data management and/or programming staff for review and modification, as appropriate.
    • Errors or problematic areas are identified prior to widespread use and corrected early.
    • The creation of written guidelines regarding completion of specific CRFs may also be considered.
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