The key to an effective Electronic Data Capture (EDC) setup is proper planning. If electronic Case Report Forms (eCRF) are not prepared well before setup, you can risk lower data quality, missing data, and delayed study start. In this post, you will learn how to use a template to remove chaos out of the equation and ease your EDC setup process.
Do-it-yourself (DIY) EDC is becoming more accessible to the industry and is commonly used for data collection in clinical investigations and post-market activities.
One of the most notable differences between DIY EDC and other EDC solutions is the no-programming approach.
A DIY EDC usually doesn't need trained data managers (or programmers) to install or use. Thus, people with basic clinical know-how can set up eCRFs without much hassle.
But, even though the setup of eCRFs has become simpler, designing an eCRF is not an easy task.
The design of an eCRF usually requires input from various experts and clinical staff. This requires study managers to develop a list of specific requirements for each eCRF. Such a list includes specifics of the variables, text clarifications, validation details, limits, and more.
To minimise the risk of setup errors, it's important to prepare these specifications beforehand, in a format that allows study teams to review and adjust accordingly.
By using a standardised template you have a structured way of documenting these specifications. This not only ensures consistency between studies but also simplifies review and QA of the eCRF before setup.
The time spent on EDC setup can also be significantly reduced because specifications are clear and well structured. As such, the setup process is no longer about designing and testing eCRF specs. But solely focused on implementing the pre-defined requirements.
But how do you go about using a template like this in your clinical study?
The SMART-TRIAL eCRF Template can be used to document specifications for all types of eCRFs. But, it's important to note that its purpose is not to provide you with a ready-to-use case report form. It's a tool to design and define your own eCRF, in a structured manner.
Download a copy of the template by clicking the button below.
The template itself is a Microsoft Excel file. You can open it up with Microsoft Excel, Google Sheets, or other similar software.
The template has 11 columns, and most of them are fairly self-explanatory. Each row represents one question, or a variable, to be collected in your eCRF. Not all columns have to be defined for every row and most columns are optional. Only a few are mandatory, such as number, question type, and question text.
When you open the template, you will notice that it includes 13 questions. These are only examples of questions that might be used in an eCRF, and should only be used as an example or guide.
To create your own eCRF, start by duplicating the sheet.
If you'd like to keep a track of more than one eCRF in this template, simply duplicate the sheet as often as you need, and give each sheet a unique name that describes the eCRF.
Feel free to adjust and edit the template according to your needs. Just remember to review the seven principles behind a well-designed eCRF before you start defining the details of each element.