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A case report form is a tool used for collecting data over the course of a clinical trial. The sponsor designs the contents of the forms and distributes them in paper or electronic format to all locations where the clinical trial is being conducted. Researchers fill out the forms, returning them to the sponsor at set intervals or the end of the trial. The data from the forms is analyzed to develop conclusions about the outcome of the clinical trial, ranging from a conclusion that a medication being tested appears to be effective and has minimal side effects to a result suggesting that a treatment method being studied does not work.
Case report forms are extremely detailed, as researchers would rather have too much data than too little. Before any case report form is sent to the sponsor, identifying information linking the contents of forms to individual patients is stripped out, in the interests of retaining privacy and keeping the study as neutral as possible. The forms include patient histories, logs of patient interactions, and notes on how patients respond to the treatment being studied in the trial.
All of this information is analyzed to see if it is statistically meaningful. Case report forms are compared against each other and researchers look at how different groups of patients in the study responded. Patients on placebos or differing levels of medication, for example, are placed in 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 anonymized, researchers avoid the potential for bias, as they know nothing about the patients beyond the generic information in the forms.
Many clinical trials use electronic recording systems for case reports. These streamline the process significantly, allow for instantaneous transmission and database searching, and also provide methods for tying in different kinds of information in a patient file without having to physically track them down. Using electronic means can also eliminate issues like poor handwriting obscuring the contents of a case report form.
As case report forms are returned, they are scrutinized, and the sponsor may generate a list of specific questions in need of clarification. Anything on a case report form that looks odd, such as an unusually high recorded weight for a patient or a strange item in a patient's medical history, must be verified by the researchers. This is designed to weed out erroneous data, such as a mistaken blood pressure reading where the numbers are inverted by the researcher when the reading is recorded.
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