What is CRF management?

Case Report Form (CRF) Management.

What are the different types of CRF?

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.

What is the purpose of CRF?

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.

What is CRF clinical trial?

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.

What are the guidelines for completing a CRF?

CASE REPORT FORM COMPLETION GUIDELINES. A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF and protocol.

Why are electronic CRFs used in clinical research?

Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data.

Why is a case report form ( CRF ) important?

The design of the Case Report Form (CRF) is critical for the capture and subsequent analysis of subject and patient clinical trial data. It is imperative that a strong collaboration exists between the programmer and other key stakeholders who either influence or are impacted by the CRF.

What does a CRF do for a programmer?

The CRF is link between the protocol, the database and the Statistical Analysis Plan (SAP). It gives the programmers the information on how the data are captured and collected.