Design of Case Report Forms
A well-designed case report form is important because it serves to preserve and maintain the quality and integrity of data. For these reasons, the CRF design needs to be standardized in order to meet the needs of all stakeholders in the research process. This necessity to meet these needs dictates that a well-designed case report will have specific attributes.
There is a wealth of stakeholders that must be considered in the design of the case report such as, “investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician” (Bellary, Krishnankutty, & Latha , 2014). A well-designed case report will have certain attributes which enhance the reports strength and clarity. Because the primary objective of CRF design is to collect complete and accurate data there needs to be such that there are safety and efficacy standards that must be met. This means that the CRF should be structured in a manner which is simple to complete and does not require assistance. The CRF should be designed with the minimum amount of data needed and should avoid overelaboration of data to maintain conciseness. The important part of the design is found in its ability to create balance between data collection and data entry ease. By designing the CRF in this way, other stakeholder can utilize the data efficiently easily. Here are a few items that the NIH recommends for designing a proper CRF:
• Use of consistent formats, font style and font sizes throughout the CRF booklet
• Selection of portrait versus landscape versus combination layouts • Use of clear and concise questions, prompts, and instructions
• Visual cues, such as boxes that clearly indicate place and format of data to be recorded should be provided to the person recording the data as much as possible
• Using the option of “circling of answers” should be limited as it’s hard to interpret; instead check boxes would be appropriate (Bellary, Krishnankutty, & Latha, 2014)
A poorly designed CRF can affect both data input and data output in a clinical trial by causing errors and inaccuracies. For instance, if the CRF is poorly designed and it is difficult to fill out then it more apt to creating errors by misplacing information on the form.
Bellary, S., Krishnankutty, B., & Latha , M. S. (2014, October ). Basics of case report form designing in clinical research. Retrieved from National Institute of Health: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/