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.
Comparison of cost to deploy an EDC and Paper study
It may be possible to produce a paper CRF and deliver those to site earlier than having an operational EDC system but any gain here is very small in comparison to the gains to be yielded using EDC.
A few of the advantages of using the SQN Health EDC system
- A fully functional eCRF in 6 to 10 weeks of the final protocol
- Flexible, template-driven, intuitive, flowing, paper-like system
- Online training, role-based and certified – typically <1hr
- Online tooltip and fully supported by our help desk
- Single transcription of source notes/worksheet to EDC
- Online validation, missing data confirmation flags
- Instantly available quality data
- Fewer data queries and minimised reliance on-site staff
- Faster CRF adjustments and deployment
- Deviation capture
- 3rd party data imports
- Query/SDV and investigator sign off
- Analytics and reporting
- Data access for pharmacovigilance, medical monitoring and safety groups
- Medical auto-coding
- Reduced Last subject visit to database lock timeframe
- CFR part 11 and GDPR compliance
- Fully audit trailed and auditable
- Secure backed up data storage
Finally, while it is a generally thought to be a standard process to issue trial subjects with paper patient-reported outcome questionnaires and diary cards, there is limited traceability, adherence to study schedule for completion and potential for lost data using paper elements.
With the SQN Health electronic patient-reported outcome (ePRO) app, we can enable a trial subject to use their own, or provided, iOS or Android device to capture data within validated questionnaires and patient diaries. A predetermined completion schedule is driven by the system and details planned completions as well as reminders. The app can send alerts to site on safety or non-conformity, submitted data is instantly transferred to and available within the EDC system which forms the hub of data availability, retrieval, reporting and audit trailing. Trial subjects are typically familiar with the use of a smartphone, and the benefit of this together with reminders and alerts maximises the data available.
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