6 Things To Include When Creating An ECRF Design | Business Upturn

6 Things To Include When Creating An ECRF Design


An Electronic Case Report Form (ECRF) is a system that allows you to collect patient data during a clinical trial. As the name suggests, this process is done digitally. The ECRF’s design needs to be top-notch for its efficiency during the trial. Based on this, what will guide your conclusion that your ECRF’s design is as it should be? This article highlights some of the aspects you need to include during the design stage. Read on for this insight and more.

Consider including the following:

  1. A Guide


The filling of an ECRF might be overwhelming to some patients, considering educational and literacy levels vary across them. Due to this, you must incorporate a guiding system.

The guiding system more or less entails giving the patients instructions on how to go about the ECRF. It’s essential to have it as an introduction before starting the questions. However, this recommendation doesn’t mean you can’t incorporate a guide within the questions. This would be vital in sections that might be difficult to answer; you can give an example of the answer you require besides the question.

Including a guide in your ECRF will prevent you from getting wrong answers that won’t help your study.


  1. The Right Systems

An ECRF will only be effective with the right tools. Such tools are ODM and CDASH. Clinical Data Acquisition Standards Harmonization (CDASH) is a system that allows uniformity regarding data collection during clinical trials. CDASH will guide you on the data to collect based on your study for relevance, including how to collect it. The uniformity allows other parties, such as reviewers and analysts, to understand your clinical trial and derive its conclusions.

When it comes to clinical trials, they’re useful today and tomorrow. A future innovator might want to study a given aspect, and they might need to refer to previous trials for guidance. This is only possible if you archive data from previous trials. With ECRF, you can achieve this by incorporating an Operational Data Model (ODM.) An ODM will store data from your clinical trials for future reference.

  1. Concise Questions

The clarity of the questions in the ECRF will determine the quality of data you’ll collect from patients.

You should formulate the questions in the easiest manner possible to allow for easy understanding. Complex questions will lead to ambiguity and a lack of understanding, which will lead to misinterpretations. With misinterpretations, the patients will fill in incorrect information, making the data collection more or less useless.

Here, it’s also essential that you frame your questions to allow for the collection of quantitative data rather than qualitative. For instance, formulate questions with yes or no answers instead of those asking about opinions. Quantitative data is easier to analyze and will give you more concrete data that you can use for your clinical trial.

  1. Self-Service Portal

As you carry out your clinical study, you’ll work with patients with varying needs and personalities. Some don’t like interaction too much, while others are chatty. To accommodate everyone, it’s best to include a self-help portal.

This enables the patient to fill out the form independently without needing assistance. With the self-help portal, the burden will ease your workers, allowing them to focus on other critical operations in the study. Also, patients will only require assistance from your team when the need arises.

  1. Regulations

An ECRF collects a lot of personal data regarding patients. A situation where this data gets into the wrong hands could be catastrophic, hence the need to include safety measures.

There are many regulations guiding the collection and handling of personal information; some are general, while others are industry-specific. These regulations are mainly the General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPPA.)

Some of the major aspects that these regulations cover are the data you need to collect for the trial, you need to disclose your use of the data to the patient, and your systems should be secure enough for the safe storage of this data. Therefore, you need to ensure your ECRF design incorporates these laws.

  1. Mandatory Fields

When carrying out a clinical trial, you require some critical information for the trial’s success. This means that the failure of your patients to give this information will render your study inconclusive. You can avoid this by including mandatory fields in your ECRF design.

With mandatory fields, the patients won’t be able to submit the ECRF form if they’ve not filled the fields out. As you do this, it’s best to refrain from being too pushy with the required fields; some patients may feel pressurized and abandon the trial altogether.


Electronic Case Report Forms (ECRFs) aim to allow for efficiency during clinical trials. With the sensitivity of clinical trials, conciseness and accuracy are required since lives are involved. This article has shown aspects that you need to include in your ECRF. Consider incorporating them into your ECRF design, and you’ll have yourself an efficiently running clinical trial.