Generate accurate reports with our Case Report Form generator

ing to ICH GCP EC 1.11, a case report form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported on each trial subject. CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site.

Standard Case Report Form Design Structured format following scientific methodology and regulatory requirements. Organized by study visit to capture all protocol-required measures sequentially. Standardized questions/response options allowing quantitative analysis across participants.

A case report form (CRF) is a document designed to record all patient information that needs to be collected during a clinical trial. An electronic CRF (eCRF) can be stored in cloud-based systems such as clinical metadata repositories (CMDRs) or Electronic Data Capture (EDC) systems.

CRFs created in text documents are more secure. Content in text documents can get corrupted or unintentionally altered by users. With eCRFs, access can be restricted and thereʼs a full audit trail of changes. Moving to eCRFs/implementing an EDC requires a lot of training time.

Case reports should encompass the following five sections: an abstract, an introduction with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, and a brief summary of the case and a conclusion.

4.3 Investigator: The Investigator is responsible for timely review and sign-off of the eCRFs to ensure accuracy, and completeness, in compliance with the protocol and regulations.

A Case Report Form, or CRF, is a research-specific document that collects all the relevant data for a given protocol. Historically, these were completed on paper but for most current studies, data is reported into an Electronic Data Capture database (or EDC).

CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site. Information documented on the CRF (or eCRF) must be supported by source documentation. At a minimum the CRF should record: Inclusion/exclusion criteria and assessment as to whether the subject met them.

Important part of the CRF is an informative header and footer, which can be customized. [7] In general, the header includes protocol ID, site code, subject ID, and patient initials. Whereas, the footer includes investigatorʼs signature, date of signature, version number, and page number.