What’s the background on CRFs?
A traditional paper case report form is known as a CRF (paper CRF or annotated CRF). An electronic case report form (eCRF) is the same as a CRF, except that it’s electronic. Both abbreviations tend to be used interchangeably, and are also referred to as forms.
CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products.
For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention to detail. They must comply with the study protocol, and record its detail. And, they must also comply with regulatory requirements, such as those defined by the FDA.
Over the last 20 years, with improvements in technology, there’s been a move towards using cloud-based systems. That’s using eCRFs and Electronic Data Capture systems (EDCs). While a lot of organizations have embraced this change and witnessed the benefits, many are reluctant to get on board.
Why organizations still use paper CRFs
Organizations like having a familiar process. They’re under time pressure to get studies done and dusted. Moving to a cloud-based system is a lot of change and causes uncertainty. So it’s a risky undertaking. On top of that, there are a few misconceptions that put organizations off.
Here are 3 misconceptions around moving to a cloud-based system:
- Using paper CRFs for studies is more cost effective.
“There’s a low clinical study start-up cost and no monthly license fees to pay. A lot of training is needed to be able to switch to EDC, and use eCRFs.”
- Data stored on paper is safer in a secure centralized location.
“Using a secure centralized location, like a vault, keeps data safe.”
- Making the move to using eCRFs and EDCs requires a lot of software training.
“Training takes up a lot of time. We already have tight deadlines and as a result, are under pressure. So additional training will take up time we can’t afford. There’s no need for software training to create paper CRFs.”
Why cloud-based systems are best
In the long run, it’s been proved that using EDCs and eCRFs provides much greater advantages than using traditional paper based methods.
Here’s why the misconceptions above, have proved to be false:
- Using eCRFs for studies can be much more cost effective.
It actually costs more to continue using paper CRFs, rather than using a clinical metadata repository and reusing standardized eCRFs. Why? More time means more costs. It takes much longer to create paper studies, and you can’t easily reuse paper CRFs because they need to be created by hand each time. Plus, annotations need to be done from scratch for every single paper CRF. There’s a much higher likelihood of data errors because data formats can’t be enforced and collected data must be manually re-entered into a computer. This is the main reason for the costs being higher. It’s only small companies doing small studies that are cost effective using paper CRFs.
- Data stored in a cloud-based system is more secure than on paper.
Data stored on paper often ends up in a briefcase, in someone’s drawer, lying on their desk, or even worse, being misplaced, or lost. Not very secure at all! Moreover, data has to be physically moved to a secure location, and that could be many miles away from where it originated. Plus, how is it transported? Potentially, these issues could be a serious threat to data security. If data is stored in a cloud-based EDC, then these risks are reduced. EDCs have encryption that secures data both in transit and when stored and off-site encrypted backups. Access is restricted, and there’s a full audit trail.
- There’s not as much training required as you think.
Using a cloud-based system that automates the process of creating eCRFs saves a ton of time. So yes, some training will be needed to get started, but the time saved for current and future studies makes up for it many times over. Using a cloud-based system like Formedix means you’ll have access to help and support from our professional services team, as well as a dedicated account manager, and access to training. We can help get you set up and walk you through our platform. These days, EDCs are much more user friendly than they used to be. So training is a fairly quick process. And EDCs have built-in help and support.
This is all great. Studies can be automated and speeded up. Data is nice and secure. Training doesn’t take too long, and it’s cost effective. But, if you don’t have good eCRF design, then successful submission to the FDA is unlikely or will take a lot longer, even using cloud-based, automated systems.
CRF design & eCRF design
Forms that are well-designed are essential for a successful clinical trial submission and getting clinical products to the market.
Well-designed forms must:
- Gather data that are complete, accurate, and high quality.
- Avoid duplication.
- Be well structured and easy for the user to complete.
- Be unambiguous and allow for accurate data entry. For example, using coded lists to limit answers to questions. And avoid open-ended questions.
- Avoid gathering more data than what is needed.
- Be consistent, well laid out, uncluttered, simple, and user friendly.
What to keep in mind at design time
To capture data correctly, here are some things to think about:
- Clear guidance using prompts and instructions should be included.
- Formats, fonts, and font sizes should be the same across all forms.
- The layout should be simple and uncluttered.
- Questions should be clear, precise, and easy to understand.
- Include consistent headers.
- Specify units of measurement.
- Visual cues should be used to show how questions are to be answered. For example, the date format, and the number of decimal places.
- Minimize the use of free-text responses or “check all that apply”.
- Keep related questions together in sections.
- For paper CRFs, include page numbering. Avoid circling answers, and make it clear which questions are mandatory.
Example of a well-designed form
Clear guidance is given for each response in the form above, so there will be no unnecessary queries. The yes / no response is coded and should be coded in the same way across all forms in studies for consistency.
Example of a poorly designed form
There’s no guidance given for responses in the form above. That means results will vary in responses from site to site, and from investigator to investigator.
CRF design & eCRF design challenges
3 common design challenges that typically come up:
- Creating forms that are consistent.
- Collecting precise data.
- Creating user-friendly forms.
To overcome these challenges there’s a number of things that can be done.
- Do proper planning, and start it early on in the study. This should be done by a team of people that include data management, biostatisticians, and clinicians.
- Define clear objectives and stick to them.
- Maintain standardized forms.
- Get user feedback. It’s best to build this into the design and maintenance process.
- Apply best practices.
- Provide form completion guidelines to reduce data capture and data entry issues. This helps investigators fill in forms correctly by providing step by step guidance, and uses clear specific instructions.
If you are interested, you can find out about using ODM and CDASH for CRF design.
Now that CRF and eCRF design are covered, the next thing to look at is annotating CRFs.
Why are annotated CRFs so important?
Annotated CRFs are a key submission deliverable, a mandatory requirement of the FDA. Each form in a study contains markings or annotations. These annotations map data points on forms to the name of datasets, and variables within those datasets. In other words, “each CRF should provide the variable names and coding for each CRF item included in the data tabulation datasets” as stated by the FDA guidelines.
The FDA stipulates that a set of blank annotated CRFs be submitted in a PDF document called “blankcrf.pdf”. This document helps the FDA reviewer find the origin of variables in the SDTM datasets.
You can read more about why it’s a good idea to switch to automated CRF annotations.
Here’s an example of an annotated CRF in Formedix.
Why should CRFs be standardized?
It’s important to standardize forms so that stakeholders such as the investigator, data manager, biostatisticians, data entry personnel, etc. have their needs met. CRFs must be user friendly and capture consistent data, that’s clear and valid.
Standardizing CRFs means you can reuse them. That’s a huge efficiency gain. They’ve already been reviewed and approved, so they’ll be consistent, and of high quality. And, annotations don’t need to be manually done on each form. You can also reuse edit checks that normally take lots of time and resources to do. So, not only is it a huge time and resource-saving, it’s a lot less hassle!
How Formedix can help
Our clinical trial automation software lets you create forms from scratch, or upload your existing forms and store them in our clinical metadata repository. Once your forms are standardized you can quickly and easily reuse them across other standards and studies. Including annotations and edit checks. It’s easy to find, share, and update your forms. And you can preview them in different formats as you design them, as well as being able to see how they look and work, in 7 leading EDCs including Rave and InForm. And we integrate 100% with Rave! Plus CRF, EDC, and CDISC validation are built-in, so you don’t have to worry about being compliant. You can find more about creating your CRF designs and EDC designs in Formedix.
You read about how a clinical metadata repository can help with data quality and you can read about important aspects you should consider before implementing one.
If you want to see Formedix in action, you can book an online customized demo. Or, if you just want to find out a bit more, you can set up a call, or contact us to tell us about your particular challenges.
And, so you can really get a handle on our platform, and what it can do, there’s the option of a free trial. That includes 6 hours of free training to get you up and running!
You can visit our website at https://www.formedix.com/
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