When people think of clinical trial data capture, the paper case report form (CRF) often comes to mind. Despite cloud-based electronic data capture (EDC) being in existence for almost 20 years, nearly 50% of clinical trials still rely on paper CRFs.
When we are so comfortable with e-mail, online banking, online shopping, mobile phones and other electronic advanced solutions, why do we still have this reliance on paper?
If a company has always used paper for its study CRFs, then their preferred data capture method tends to continue with what is a familiar process. Paper CRFs are still considered by some to have advantages over EDC: lower upfront costs, rapid availability of CRFs to the site, no specialist data entry training and a physical multiple copy secure data storage. In some cases, paper will also be used in conjunction with electronic data capture i.e. questionnaires/diary cards etc.
At SQN we developed our own SQN Health EDC system, it was specifically designed to alleviate the process of migration from paper to EDC and to give all the advantages of EDC. Our system continues to provide comprehensive and intuitive data capture and reporting hub to all of our projects.
With any clinical trial, there is a required balance between time, data availability and cost, these being different for each trial and often dependant on the organisation, funding and phase of the trial. Any good EDC system should be flexible and provide the ability to tailor its design to fit the constraints of the project.
The initial set-up time and cost of an electronic CRF (eCRF) is often perceived to be higher than those associated with the creation, printing and distribution of a paper CRF but in our experience, this is very rarely the case. Only very simple studies with very small populations are cost-effective in paper, you will however probably have to wait longer to see the data and results.