Case Report Forms 2025

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The document outlines the importance and design principles of Case Report Forms (CRFs) in research studies. It emphasizes the need for well-structured, user-friendly forms that collect relevant data accurately to ensure successful study outcomes. Key sections include planning, anatomy of a CRF, data inclusion criteria, and best practices for question formulation. The document also highlights the significance of collaboration among study team members and the necessity of pilot testing forms before data collection.

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What are the two types of clinical research?

Paper-based CRF forms must be transcribed into a computer database before analysis, which introduces the potential for transcription errors. Collecting data electronically with eCRF eliminates transcription errors and results in better quality data.

Who should be signing off the case report forms?

The CRC will ensure that all required data are collected and entered on the CRF as soon as possible after, if not during, the visit. All CRFs should be checked for completeness and legibility. The CRFs should be reviewed and signed by the investigator prior to submission.

What is the difference between paper CRF and electronic CRF?

While CRFs capture essential standardized data, non-CRF data provides additional context and real-world evidence that can enhance the quality and relevance of trial results.

What are the different types of CRF in clinical research?

Clinical research is the study of health and illness in people. There are two main types of clinical research: observational studies and clinical trials. Read and share this infographic (PDF, 317K) to learn why researchers do different kinds of clinical studies. Observational studies monitor people in normal settings.

What are the two types of CRF?

There are two main types of CRFs: Paper-Based CRF and electronic CRF ( eCRF). Paper-Based CRF: This type of CRFs is used in traditional clinical trials, to collect and record data about the participants in the clinical trials, including their demographics, adverse events, and treatment results. Electronic CRF or eCRF:

What is the case report form?

A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting.

Case Report Forms 2025

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