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In clinical investigations, investigators traditionally use paper Case Report Forms (CRFs) to collect data from participating patients, including patient characteristics and demographic data, adverse events, and the results of experimental treatments.
When a study is completed, paper CRF forms are boxed and shipped from the study site to the study sponsor, where the data will be cleaned, prepared, transformed, and transcribed into a computer database prior to analysis.
Paper-based CRFs have been standard practice in clinical investigation for decades, but medical device companies in recent years are increasingly choosing to digitize the data collection process with a new kind of CRF: electronic Case Report Form (eCRF).
In this essential guide, we’ll cover all the basics about eCRFs in clinical trials for medical device companies. You’ll learn what they are, how to design an effective eCRF, and the benefits of choosing eCRF instead of paper-based CRF for your next study.
An eCRF (electronic case report form) is the digital version of a paper-based case report form - it’s a digital questionnaire completed by researchers to collect and report data from participating patients in a clinical trial.
While paper CRFs require physical storage, security, and transportation, collecting clinical data in a digital format with an eCRF means that the data can be securely uploaded to the cloud and shared with other stakeholders in near-real time.
As a result, switching from paper-based data collection to eCRF can help medical device companies execute clinical studies in less time, with less risk, and at a lower cost.
eCRF and Electronic Data Capture (EDC) are semantically similar terms that relate to data collection in clinical studies, which explains why certain sources are using these terms interchangeably.
Still, eCRF and EDC are not the same thing and clinical study managers should understand the difference between them.
We’ve already defined eCRFs above as the digital version of a case report form that researchers will complete during a clinical trial.
An EDC system is a software solution, purpose-built to enable data collection as part of a clinical study. EDC systems allow sponsors to design eCRFs and provide a graphical user interface where researchers can complete and submit eCRFs as part of a clinical study.
EDC systems can also enable other forms of data collection, including automatic transmission from electronic health records (EHR) and connected medical devices.
Plus, EDC systems enable software-based controls on data entry and data access that help ensure the accuracy, authenticity, and security of clinical data. Click here to find out what other advantages to using an EDC system are and why it is a good idea to use an EDC made for medical devices.
Concerned about the impact of adopting eCRF on clinical workflows? You might be wondering whether you can simply transcribe paper CRF documents into eCRF instead of requiring researchers to record data in a digital format.
You absolutely can choose to transcribe data into eCRF from paper source documents, however:
You will need to design a paper CRF and a matching eCRF to streamline the data entry process.
You will need to retain the source data in paper format to satisfy regulatory requirements.
The transcription process will introduce data entry errors that negatively impact data quality.
If your goal is to use eCRF in your study, designing your eCRF in a digital format is highly recommended, as your digital CRF can easily be transposed to a paper copy if needed. In contrast, it is often both time-consuming and costly to design a paper CRF and recreate it in a digital format.
However, we recommend designing your eCRF from scratch, instead of copying the design from the paper-based CRF. Download our eCRF template to get the design of your eCRF right.
eCRFs are designed by clinical trial sponsors to collect data from a clinical investigation that can be used to test the experimental hypothesis and answer research questions that are relevant to the study.
A common mistake in eCRF design is trying to collect too much data. Including more data fields on your eCRF means more time and money spent on data collection, entry, preparation, and analysis. A well-designed eCRF should capture just the data needed for the study, without any time-consuming extras that lengthen the data collection process without adding anything useful.
To achieve this, trial sponsors should plan their clinical investigations and data collection activities in detail before designing an eCRF. Here’s how to start designing a high-quality eCRF:
The first step to designing an eCRF is to craft a clear research hypothesis for your clinical investigation. Your hypothesis should include a prediction for how your medical device will help patients in the treatment group.
Establishing a hypothesis is a critical step towards clarifying what data you must collect to support or refute your hypothesis, and what other data can safely be ignored in the context of your investigation.
After establishing a hypothesis, you should prepare a Statistical Analysis Plan (SAP) describing how the data you collect during the clinical trial will be analyzed. This is when you’ll list exactly what data must be collected, and when, to enable a sound analysis that will either support or refute your research hypothesis.
Your SAP may also include descriptions of specific graphs, charts, or other visuals you hope to create using the data collected in your clinical trial.
A data collection plan defines the specific questions you will ask to collect the data that’s needed to support or refute your research hypothesis. You can also document how those questions will be asked and how they might be formatted on a digital case report form (eCRF).
You can download our eCRF template to help you start documenting specifications for your eCRF as part of your data collection plan.
Planning data collection activities means describing how researchers will collect, capture, and store data during your clinical trial. To solidify your plan, you’ll need to document the answers to questions like:
What data is available?
What data will be collected?
How much data will be needed?
How will the data be collected?
When will the data be collected?
Who will collect the data?
Where will data be recorded or stored?
How will data be shared?
By crafting a research hypothesis and establishing clear plans for gathering and analyzing your clinical data, you should be able to avoid the common mistake of collecting more data than is needed to test your research hypothesis.
This is only one of the 7 most common pitfalls in clinical data collection for MedTech that we have identified along the years. If you want to learn how to avoid tripping over these pitfalls (you may not even know you're doing it already), we suggest you check out our blog post, here.
SMART-TRIAL EDC gives our customers the ability to design and customize eCRFs for medical device clinical investigations, clinical performance, post-market clinical follow-up (PMCF), and post-market performance follow-up (PMPF) studies.
To share our expertise, we’ve authored a white paper detailing the most important best practices in eCRF design. In the paper, we identify the seven principles behind a Good eCRF design and how you can apply them to create a perfectly optimized eCRF for your next clinical study.
Medical device companies doing paper-based data collection must maintain a physical copy of the original source data for security and compliance purposes. Using eCRF in clinical trials eliminates the need for data duplication and allows medical device companies to satisfy these requirements by storing data securely in the cloud with appropriate back-ups.
Paper-based CRF forms must be transcribed into a computer database before analysis, which introduces the potential for transcription errors. Collecting data electronically with eCRF eliminates transcription errors and results in better quality data.
When researchers complete paper CRFs in a study, those records must be packaged, shipped, and transcribed before the data can be analyzed. With eCRFs, any data collected by researchers during a subject visit is available for review and analysis in near-real time - just as soon as it’s entered into the EDC system.
Streamlining access to data accelerates the completion of clinical studies, provides a faster feedback loop for researchers, and enhances data access for all research stakeholders.
Collecting clinical data with eCRF can help medical device companies facilitate good compliance with clinical investigation standards like ISO 14155:2020. EDC software can also deliver automatic warnings and notifications to help companies comply with Good Clinical Practices (GCP) as outlined by the International Conference on Harmonization (ICH).
Clinical study monitors are responsible for ensuring that studies proceed in compliance with the experimental protocols, GCP, and relevant regulatory requirements. They also work to ensure that the rights of subjects are protected, and that study data is accurate and complete.
Using eCRF enables monitors to remotely access documentation from the clinical study over the Internet as an alternative to supervising the study in person. Remote monitoring reduces costs and increases the efficiency of clinical studies.
Data recorded on eCRF is not constrained to a single physical location. Instead, the data is uploaded to the Internet where it can be accessed almost immediately by other stakeholders with the appropriate authorization and access credentials.
Paper CRFs are subject to a number of physical risks, including loss, theft, fire and water damage. Medical device companies can eliminate these risks by collecting data with eCRF and storing the data in a secure cloud environment.
When clinical data is collected using eCRF in clinical trials and securely stored in the cloud, a digital data trail is created and preserved for inspector audits and regulatory review.
Scientific research on the impact of choosing eCRFs over paper-based data collection have suggested that eCRFs accelerate the completion of clinical studies and reduce the cost of data collection. In one research paper that analyzed data collection in 27 clinical studies between 2001 and 2011, those using eCRF had a total cost of 374€ (381 usd) per patient, while those with paper-based data collection cost 1,135€ (1156 USD) per patient.
Greenlight Guru Clinical (formerly SMART-TRIAL) is an EDC system that enables clinical study sponsors to digitize the process of collecting, integrating, and securely storing data for clinical investigations, in-human studies, and post-market surveillance activities.
With Greenlight Guru Clinical, medical device companies can design highly customized eCRFs, then deploy those eCRFs in clinical studies to replace paper-based data collection, eliminate the risk of transcription errors, and reduce the cost of running the study.
As the first and only electronic data capture software designed for Medical Devices and Diagnostics, Greenlight Guru Clinical provides capabilities for gathering data in clinical studies, performance studies, PMCF/PMPF studies, surveys, registries, cohorts, case series, as well as from connected devices and wearables.
Ready to learn more? Contact us for a customized demo.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.