The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their 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.
Examples of data that would lead to 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.
To ensure quality control, these queries are usually addressed and resolved before the CRF data is included by the sponsor in the final clinical study report.