With improvements in technology over the last 20 years, there’s been a move towards creating and maintaining eCRFs using cloud-based systems like CMDRs and EDCs.
Despite this shift, some organizations continue to store their CRF templates in text documents or other similar methods.
In our risk-averse industry, organizations feel more comfortable with a familiar process. They’re under pressure to get studies live and meet the first patient in (FPI). Moving to a cloud-based system involves significant change, and organizations see change as a cause for uncertainty and risk. On top of that, there are some misconceptions around switching to a cloud-based system, that deter organizations from making the change.
We’ve analyzed three common misconceptions below:
Myth 1: It’s more cost-effective to design CRFs in text documents.
Fact 1: Designing and storing eCRFs in cloud-based systems can be much more cost effective than other methods.
It actually costs more to continue using text documents or spreadsheets, rather than switching to a CMDR/EDC set up. The most up to date versions of forms and annotations need to be located, edited, approved, or re-created from scratch each time. There’s also a higher likelihood of data errors with this method because formats can’t be enforced so easily. Getting CRFs ready for use can be a time-consuming process, and therefore costly.
In comparison, standardized, approved eCRFs stored in a cloud-based system are easily located and ready for reuse, which creates efficiencies; they’ve already been reviewed and approved by stakeholders, and you know that they capture clear and valid data.
Myth 2: Data stored in text documents or spreadsheets is safer.
Fact 2: Creating and maintaining CRFs using text documents and spreadsheets can be tedious and error-prone. Content in text documents can become corrupted or unintentionally altered by users. Locating the latest version of a CRF that has been approved by all stakeholders can be tricky.
On the other hand, EDCs use encryption to secure data both in transit and when stored, in addition to off-site encrypted backups. With EDCs, access is restricted and there’s a full audit trail for traceability.
Myth 3: Making the move to using eCRFs and EDCs requires a lot of software training.
Fact 3: There’s less training required than you think. Using a cloud-based system that automates the process of creating eCRFs saves lots of time. Some training is required to get started, but the time saved in the long term makes this method far more efficient.
Using eCRF design software typically gives you access to a technical support team. Plus, EDCs are user-friendly and have built-in help and support.
Myth X
Fact ✓
CRFs created in text documents are more cost effective.
It actually costs more to continue using text documents or spreadsheets, rather than switching to electronic CRFs.
CRFs created in text documents are more secure.
Content in text documents can get corrupted or unintentionally altered by users. With eCRFs, access can be restricted and there’s a full audit trail of changes.
Moving to eCRFs/implementing an EDC requires a lot of training time.
There’s less training required than you think, and using a cloud-based system that automates the process of creating eCRFs saves lots of time.
To recap, studies can be automated and accelerated, which means time and cost efficiencies, data is secure, and there’s training and support for onboarding and beyond.
Whatever system you choose, there are some things you should know about how to design effective CRFs.