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A CRF, or case report form, is the document used to collect all required patient data during clinical trials. It is designed to ensure the consistent capture of data from all the different sites involved in a trial. These sites could be hospitals, clinics, university hospitals, research centers, or private practices to name a few examples. The data collected on a CRF includes everything from personal patient data to treatment responses and endpoints. This is an example of a clinical trial CRF below. Want to learn more? Learn all about CRFs in our blog, Everything You Need to Know About CRFs in Clinical Trials.

CRFs collect all of the patient data associated with a specific drug trial. This data includes everything from patient demographics to the results experienced by the patient at the end of the trial. Each trial will collect slightly different data depending on the nature and purpose of the drug being tested. However, the following are commonly collected as standard across clinical trials:

• Demographics, such as age, gender, ethnicity, occupation.
• Medical history, such as any previous surgery, any allergies, any relevant family medical history.
• Treatment details, such as drug dosage, frequency, duration, any simultaneous treatments.
• Lab results and assessments, such as blood counts or hormone levels, and physical affects and functions directly reported by the patient, such as from questionnaires and physical examinations.
• Adverse events, such as any side effects or reactions to the treatment experienced by the patient
• Efficacy outcomes, in other words, did the patient survive, were they cured, or were their symptoms reduced.

The role of a CRF in clinical trials is to ensure that all of the data required for analysis and decision making in the lead up to regulatory approval is successfully captured. This includes the data being consistently captured across all clinical trials, in order for regulatory agencies – like the FDA, PMDA and MHRA – to efficiently review the collected data, and easily make comparisons across trials, for example. How do CRFs ensure data quality and compliance? Learn more about how to design high quality CRFs in our guide, A Best Practice Guide to CRF Design.

A paper CRF is a physical piece of paper that’s used to manually collect patient data. This would typically be a word document that’s completed by hand by nurses, clinicians, etc. An electronic case report form, eCRF, is a digital version of a paper CRF. An eCRF collects exactly the same patient information as a paper CRF. However, paper CRFs can be subject to difficulties, such as: manual data entry errors; duplicated repetitive tasks; delays due to handwritten work taking longer; manual errors needing to be resolved and fixed; and the inability to find and share the relevant paperwork with required stakeholders. In comparison, Electronic CRFs (eCRFs) do not have these issues. eCRFs are not hand written documents but are computer produced documents. Data entry and validation checks are performed digitally, on the computer, removing the risk of human data entry mistakes, and meaning any errors may be caught and resolved in real-time. eCRFs are typically stored in a central cloud-based platform, which is globally accessible by all stakeholders.

You can quickly and easily design eCRFs with Pinnacle 21 CRF design software. The first step is to choose the EDC system you’re using. Pinnacle 21 integrates with all the leading EDCs, including Rave and Veeva, so just pick your preferred EDC. Next, select which forms to use from your standardized CRFs, saved in your library. Then you can preview how the CRFs look and work for your chosen EDC system in the Pinnacle 21 CRF Creator platform. That means stakeholders can review and make edits directly in the Pinnacle 21 platform without having to first build the study. Once your eCRFs have been reviewed and approved by all the relevant clinicians and data managers, just press a button to build the study for your EDC system. Want to learn more? Read the fact sheet about Pinnacle 21 CRF Creator software here.