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CRF design

CRF stands for a case report form, a document used in clinical trials to collect and record study data. It is an essential tool for capturing accurate and consistent information from subjects during a clinical trial. The purpose of a CRF is to systematically collect data on various aspects of the study, including the subject's demographics, treatment details, adverse events, and other relevant information.

Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), require complete and accurate documentation of clinical trial data. CRFs play a vital role in meeting these regulatory requirements by providing a detailed record of all relevant information. The collected data can be used to evaluate the safety and efficacy of the investigational product, assess adverse events, compare treatment groups, and draw conclusions about the trial's outcomes.

With data integrity, quality control, and regulatory compliance in mind, CRF design aims to achieve a standardized format for data collection, introduce validation rules and edit checks to prevent errors or inconsistencies, and ensure that all investigators and study sites invariably collect information. This helps to minimize variability and potential bias in data collection. However, for hierarchical study design, where there is a master study with its substudies, SD configurations provide flexibility to configure individual CRF designs for the master and all the substudies while having common dependencies and rules for validation.

CRF design functionality
Figure 1. CRF design functionality

CRF maintenance also requires versioning to keep track of all changes that may be introduced during the study to satisfy changing protocol requirements, ensure patient safety, and so on. In terms of CRF version management, CRF design becomes one of the stages of the version's lifecycle, as depicted in the following schema.

CRF design as part of CRF version lifecycle
Figure 2. CRF design as part of CRF version lifecycle

The Study Designer application of the eClinical suite provides a variety of tools to design a CRF. These tools and the purpose of their usage are described in the following sections:

In this section:

A participant who is enrolled in a clinical trial and assigned to the site.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A national regulatory agency that controls the development of new drugs and standards compliance by clinical trial researchers.

Learn more about FDA on the official website.

A decentralized scientific agency that regulates the evaluation and supervision of the manufacture of medical products in Europe.

Learn more about EMA on its official website.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

case report form (CRF)eCOA