Case report forms are used to collect detailed data during clinical trials, which is analyzed for statistical significance to draw conclusions about the effectiveness of treatments. Electronic record keeping systems simplify the process and eliminate potential bias. The sponsor reviews the forms and investigates any anomalies to ensure accuracy.
A case report form is a tool used to collect data during a clinical trial. The sponsor designs the contents of the forms and distributes them in print or electronic format to all clinical trial sites. Researchers fill out the forms, returning them to the sponsor at set intervals or at the end of the trial. Data from the modules is analyzed to develop conclusions about the outcome of the clinical trial, ranging from a conclusion that a drug under test appears to be effective and has minimal side effects to a finding that suggests a studied treatment method is not working.
The case report forms are extremely detailed, as researchers would rather have too much data than too little. Before submitting any case report forms to the sponsor, identifying information linking the contents of the forms to individual patients is removed in the interest of maintaining privacy and keeping the study as neutral as possible. Forms include patient histories, patient interaction records, and notes on how patients are responding to the treatment being studied in the study.
All of this information is analyzed to see if it is statistically significant. Case report forms are compared against each other, and researchers look at how different groups of patients in the study responded. Patients treated with placebos or different levels of medication, for example, are placed into different groups for analysis. This information is used to empirically describe the results of the clinical trial. Because the material on a case report form is anonymous, researchers avoid the potential for bias, as they know nothing about patients beyond the generic information on the forms.
Many clinical trials use electronic record keeping systems for clinical cases. These significantly simplify the process, allow for instant transmission and database searching, and also provide methods for tying different types of information into a patient file without having to physically trace it. Using electronic means can also eliminate problems such as poor writing obscuring the contents of a case report form.
When case report forms are returned, they are reviewed and the sponsor can generate a list of specific questions that need clarification. Anything on a case report form that seems odd, such as an unusually high recorded weight for a patient or an odd item in a patient’s medical history, needs to be verified by investigators. This is designed to eliminate erroneous data, such as an incorrect blood pressure reading where the numbers are reversed by the researcher when the reading is recorded.
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