Case Report Forms (or CRFs, for short) are an integral component of clinical trials. Most of the time, participants in clinical research are not even aware of CRFs. But they are a key component for recording the data in a clinical trial.
Each clinical trial participant has a CRF file. For some trials, there may be only a handful of CRFs, but some studies include thousands of participants, and each CRF may be hundreds of pages long. That's a lot of data to track!
Research site staff (investigators and study coordinators) note the measures and findings, as defined in the study protocol, and transfer the data to the study sponsor (such as Lilly) for analysis. If the data in the individual CRFs are not correct, the results of the overall trial may be compromised.
Read on for a guided, visual journey as we help to make sense of Case Report Forms.
What is a Case Report Form?
A CRF is a set of documents that collects data and information from a clinical trial. The CRF is used by the study sponsor to capture and retain important data in the clinical trial. CRFs are usually electronic but may also be created in paper form.
How are Case Report Forms developed?
The CRF is based on the measures defined in the study protocol. The main goal of the data collection is to capture the primary safety and efficacy endpoints of the study. Sometimes those measures are collected daily, but it depends on the study design and the endpoints being measured.
What type of data is captured in the CRF?
Nearly every clinical trial will collect basic information such as blood pressure or will require blood draws for lab analysis at various time points. Additional endpoints and measures depend on the disease being studied. For example, a trial for Crohn's disease or ulcerative colitis would collect data from stool samples or colonoscopy. (Check out our IBD subsite for more information on typical endpoints for these types of trials.)
Examples of basic information included in a CRF:
- Date of Visit
- Blood pressure
- Pulse
- Temperature
- Respiration
- Height
- Weight
You may be surprised to learn that not all patient data is collected in the CRF. Personal identifiable information is not included, such as:
- Patient name
- Date of birth
- Social Security number
- Address
- Phone number
Excluding these details protects your privacy rights during the trial.
What happens to CRF data?
Throughout the trial, certain clinical data is captured, as defined in the study protocol. Once the data is captured, it is sent via electronic gateway to the sponsor's database. The sponsor then reviews the data for inconsistencies and may ask clarifying questions to the site. On-going reviews occur as data is collected to ensure that it is safe to continue the study.
At the end of the trial, CRF data from each study participant is fully analyzed to see whether the experimental medication worked. The compiled data results are documented in the clinical study report to provide the final results.
(We used this scholarly article as a reference for this blog article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/ ).