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Case study questionnaire

The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test case study questionnaire hypotheses or answer their research questions.

The size of a CRF can range from a handwritten one-time ‘snapshot’ of a patient’s physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient’s participation in the clinical trial. From the sponsor’s point of view, the main logistic goal of a clinical trial is to obtain accurate CRFs. However, because of human and machine error, the data entered in CRFs is rarely completely accurate or entirely readable.

To combat these errors monitors are usually hired by the sponsor to audit the CRF to make sure the CRF contains the correct data. When the study administrators or automated mechanisms process the CRFs that were sent to the sponsor by local researchers, they make a note of queries. Queries are non-sensible or questionable data that must be explained. Examples of data that would lead case study questionnaire a query: a male patient being on female birth control medication or having had an abortion, or a 15-year-old participant having had hip replacement surgery.

Multiple case study analysis

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