Case report forms are one of the most important data instruments used for clinical researches and medical examinations. When conducting clinical trials, the researcher needs to record even the smallest of observations as they happen. A case report form is designed for this purpose.

In a case report form, you can track the unique changes of each research subject as the clinical trial progresses. This article will discuss different case report forms and show you how to create this form from scratch using Formplus. 

What is a Case Report Form? 

A case report form is an essential tool for clinical research, although it has been extended for use in other areas of medicine. Primarily, it is a record of all symptoms, signs, diagnosis, treatment, follow-up, observations, changes, and other important information from each research subject during clinical trials. The data gathered via case report forms (CRFs) are analyzed to arrive at the research results and draw valid conclusions. 

It is one of the most effective ways to systematically collect and store all the information from research for use. For example, during clinical trials to test the efficacy of a drug, you need to collect data at every stage of the process to answer all your research questions. 

In a broader sense, a case study is a questionnaire used for collecting data from patients in the course of any medical procedure, including diagnoses and treatments. It provides valid information that makes up the patient’s medical history which can be used for medical research.

Importance of a Case Report Form 

1. It provides valid information for hypothesis-testing during clinical research. 
2. A case report form captures standardized clinical data at every stage of the research process. This data is analyzed to arrive at research outcomes.
3. Case report forms play an essential part in medical research breakthroughs. By storing unique data from each research subject, case report forms create a large pool of verifiable medical research information. 
4. It improves problem-based medical education. 
5. Data from case report forms make up a large chunk of peer-reviewed journals in medical research. 
6. Medical researchers leverage existing data from different case report forms to advance systematic investigations in specific fields and sub-fields.
7. Data from case report forms have helped us develop treatments and vaccines for different diseases, viruses, and infections. 

Types of Case Report Form 

Paper Case Report Form

A paper case report form is the traditional method of collecting data during clinical trials. It is the use of paper questionnaires and paper-based systems to gather detailed information from research subjects as per the study protocol. This data is extracted, organized and analyzed to arrive at valid research outcomes. 

Advantages of Paper Case Report Forms

1. It is relatively easier to create and implement paper case report forms. 
2. It allows you to collect research data in remote areas without electricity supply and internet access. 

Disadvantages of Paper Case Report Forms

1. Data loss due to theft and exposure to natural elements like fire outbreaks and floods. 
2. It is difficult to organize and analyze large volumes of data. 
3. When dealing with large volumes of information, it can be challenging to sort the data sets. 
4. It is time-consuming and prone to errors. 

Electronic Case Report Form

An electronic case report form is an online questionnaire used for data collection in medical studies and clinical trials. This method of data collection in medical research was introduced in the late 1990s following the shortcomings of paper forms. Electronic case report forms support more accurate data collection and faster data processing. 

Advantages of Electronic Case Report Forms

1. It allows for faster data collection; especially when you are dealing with large volumes of data. 
2. It reduces data losses, errors and costs. 
3. ECRFs allow you to share data remotely among different stakeholders in the research process. 
4. It facilitates rapid data capture and data management. 
5. Easy and transparent access to research data at all times. 

Disadvantage of Electronic Case Report Forms

1. High costs depending on the complexity of the electronic case report form.

Case Report Form Template Examples 

• Case Report Form

Use this case report form from Formplus to collect specific data from patients as part of the standard medical research procedure. With this survey, you can gather all the important information you need from the patients at once, and then go ahead with a proper diagnosis.

•  Health Care Proxy Form

The Formplus health care proxy form serves as a legal document for individuals who want to empower others to make decisions for them when they are sick or unavailable. With this form, individuals can formally select their health care providers to act on their behalf when the need arises. You can also edit this proxy form to suit unique needs in the form builder.

• Medical Information Form

With the Formplus medical information form, patients can easily keep track of their health status by having all the information they need in one place. This form collects relevant information about the individual’s medical history, bio-data and doctor’s contact information in case of emergency. 

• Clinical Report Form

Are you conducting any type of clinical research? This form will help you to seamlessly gather and analyze all the data you need for your systematic investigation. While this is a template, you can always edit it to suit your needs using the different features in our drag-and-drop form builder.

•   Physical Examination Report Form

As you conduct physical examination of your patient, you can put all the information you gather in a Formplus physical examination form. This form allows you to collect data like the gender, weight, blood pressure and height of the patient. Our physical examination form makes it easy to document the patient’s health history. 

• Self Report Form

To make it easier for patients to check for symptoms and monitor their health, you can edit this self-report form and embed it on your hospital’s website for easy access. With this form, health officials and medical practitioners can keep track of and monitor the health status of their patients and employees if the need arises.

Why Use Formplus to Create a Case Report Form? 

A case report form can be administered as a paper form or an online form; that is, ECRF. Data collection platforms like Formplus allow you to create secure online CRFs with data validation and data export features. You can also generate reports from the data in the form analytics dashboard.

1. Collect Data Anywhere: Formplus allows you to collect research data in locations with poor or no internet connection using offline forms. The information filled into the case report form is automatically updated on our servers or your preferred cloud storage system once internet access is restored. 
2. Collect Data on Mobile Devices: You don’t need to have a laptop to record responses on your Formplus form. All Formplus forms are mobile-friendly and allow you to fill in responses from your smartphone. This allows you to record data on the go as you conduct clinical trials. 
3. Analyze Data Easily: In the form analytics dashboard, you can access important insights about your data and data collection process. You can automatically generate custom visual reports for your form data using the reports summary tool available in Formplus. With just a few clicks, this tool instantly displays selected form fields and form data as custom graphs and charts.
4. Add Multiple Form Fields: With more than 30 form fields, you can collect different types of information in your electronic case report form, seamlessly. You can add long text fields for open-ended questions and different types of scales and radio fields for closed-ended questions. 
5. Export Data: Formplus allows you to export research data to other file formats including CSV, PDF and Google sheets. This makes it easier for you to collaborate with others and share data from your online case report form easily. 
6. Teams and Collaboration: With teams and collaboration, you can easily keep all the members of your research team in sync as you work on forms, data, and responses. Formplus allows you to add important collaborators to your shared account so that everyone can have access to the clinical trials reports in real-time. 

How to Create Electronic Case Report Forms With Formplus

1. Create a free Formplus account on www.formpl.us. Then log into your new account to view your dashboard. 

2. Click on the “create new form” button to access the Formplus dashboard. 

3. In the Formplus dashboard, you can add multiple fields to the online case report form. Drag and drop the fields you want from the builder’s fields section into your form. 

4. Edit the form fields to include your question, options and other information. Here, you can also set the fields as required or read-only. 

5. Save all the changes you’ve made to access the form customization section. Use the different features and options to tweak the look and feel of your case report form. 

6. Copy the form link and share with respondents. 

Conclusion 

In this article, we have looked at different types and use-cases for case report forms. As a researcher, it is best to use electronic CRFs that reduce your risk of data losses and help you record information faster. 

When you sign up for a Formplus account, you can access different case report form templates to help your research. From medical information surveys to health care proxy forms, you are sure to find a template that suits your research purpose. In the form builder, you can edit these templates to align them with your research goals.