eCRF Design Systems

What is eCRF

eCRF comes from CRF, which stands for Case Report Form. It is a document that records all of the information required by the protocol to be reported to the sponsor of the trial subject. CRFs are helpful in estimating the safety and use of clinical products. eCRF is an electronic version of a CRF document that is stored in cloud-based systems. With the technological advances, more and more specialists in the field are switching from CRF to their electronic variant.  

The components of eCRF design

For eCRF documents to be accurate, they should have a well-organized and convenient design. There are different design systems for eCRF. The collected data can be entered in such ways: manually or transferred from an external database, piece by piece or all at once, by a clinical specialist or the participant of the research. Before creating an eCRF design system, the data management and validation plans should be developed.  

To ensure the reliability of the eCRF, it should have a certain structure with the required components, safety measures and controls. The basic components of an eCRF include:

1. A form label that concisely provides a description of the questions asked in the form
2. A group label that sub-categorizes the form label
3. An item label that includes a prompt for entering a particular piece of data
4. An item hint or description is a concise instruction for entering data
5. A field that is an empty space for entering value  
6. Value that is the input of the estimated procedure
7. A choice label that offers a choice among multiple options
8. Data validation or edit check to make sure the entered data falls within the right criteria range.

User-friendliness in eCRF design systems

To become user-friendly, eCRF design systems also focus on clear form layout and navigation, comprehensible text, the precision of the guidance, the importance of the collection of the stated data, unambiguity of error messages and the rules of document accessibility. Also, for international studies, eCRF systems can include multilingual documents. The availability of data, speed of transfer, automated alert process and plausibility checks will increase the usability of the eCRF system. User-friendliness can ensure the improvement in the workflow of medical specialists. 

User acceptance testing

After making sure, the eCFR design system matches all the necessary criteria, it is also important to conduct user acceptance testing to check the functionality and usability of the document. A medical specialist  who has not worked with the tested eCRF before uses it to check various components necessary for practice. These components include data entry, the process of query and monitoring. After such studies, a user acceptance test report is compiled where all the necessary corrections and changes are stated. After their implementation, new testing is necessary for their validation. 

To conclude, electronic Case Report Forms are a valuable instrument in data collection during clinical trials. Storing data from the studies in cloud-based systems is secure and easy. eCRFs have certain requirements for their structure, which must be implemented in their design. They should also be user-friendly and tested for user acceptance before being deployed in medical research.