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Any errors on the CRF should be corrected by drawing a single line through the incorrect value/text so that it is still legible.
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
Case Report Forms Used as Source Documents Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated in the protocol; however, it should not be general practice for all data collected during a clinical trial.
A case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study.
Primary objective of CRF designing is to gather complete and accurate data by avoiding duplication and facilitating transcription of data from source documents onto the CRF. CRF should be designed with the primary safety and efficacy endpoints as the main goal of data collection.
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A Case Report Form (CRF) is a printed or electronic document that is created and used in clinical trial research to capture standardised clinical data from each patient separately and to transfer it to Data Management.
Most commonly used standard CRF templates are inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication and study outcome modules, whereas, the modules which captures efficacy data are not unique. Their design varies from study to study depending on the protocol specifications.
This form can be either paper or electronic. In a paper-based clinical trial, a CRF is a printed document that investigators use to collect handwritten identification information and response data about a patient during the course of a visit.
CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis.
How to Prepare Case Report Forms Paper or Electronic Formats. There are two types of CRFs, the traditional paper form and the newer electronic format (eCRF). ... Design Tips. A well-drafted CRF will ensure the integrity and quality of the data collected. ... Examples. ... Templates. ... Conclusion. ... REFERENCES.