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Clinical Trials—Case Report Forms

The case report form (CRF) is the principal mechanism for clinical trials data collection. Case report forms can directly affect the success or failure of a clinical trial, since evaluation of the questions posed by the study is based on the information captured on these forms. Consequently, it is important to have design principles well in mind before beginning this process.

Design Principles

Case report forms should be built so that they:

  • Gather accurate information that answers study questions, and are consistent with study protocol.
  • Organize and label forms and fields so that data entry is intuitive.
  • Avoid duplication of data.

A Case for Standard Templates

Standard case report form templates are a good idea for several reasons:

  • Eliminate form duplication: some of the data requirements are the same across studies, such as demographics, admission checklists, concomitant medications, and adverse events. This is particularly true for organizations that carry out multiple studies in the same research area.
  • Simplify creating new case report forms: templates can be customized as needed; there is no need to start from scratch.
  • Reduce the data entry learning curve: Templates that use the same visual style and basic organization become familiar to those entering the data, reducing the data entry learning curve for each new study.

Advantages of Electronic Case Report Forms

Electronic case report forms, sometimes called eCRFs, have several advantages over paper forms:

  • Reduce data entry time and chances for error: eliminates the paper form step. Entering the data in electronic case report forms means entering the information directly into the clinical trials application.
  • Eliminate duplicate data entry: repetitive data—such as a patient ID, study number, date—can replicate automatically from the first form to all others.
  • Produce more accurate data: electronic case report forms can be configured to check for—and prevent—errors and omissions.
  • Facilitate analysis: data from one case report form can be linked easily to another form for analysis purposes.