Case Report Form: All you should know

Case report forms are an essential part during clinical research development. All clinical data obtained from the study are collected and managed in a case report form. to be then analyzed and to draw conclusions. In this article we are going to delve into the importance of this tool and explain all a professional should know to make a good use of the case report form.

What is a case report form and what should it contain?

Clinical research intends to collect information to answer medical questions that are to be investigated or confirmed, for example, the causes of a certain pathology, the efficacy or safety of a medical treatment, the early diagnosis of a disease, etc. During the development of a study, many data are obtained and they must be stored somewhere systematically; this is why case report forms are used.

This tool has long been used in the field of clinical studies and has evolved a great deal over the years. Traditionally, paper forms were used to collect data, but since the nineties, and with the spread of the Internet, eCRFs or electronic case report forms have prevailed.

Normally, they are computer software or cloud systems that meet the following characteristics:

• Forms: A case report form should contain all the necessary information to evaluate the objectives of a study and, at the same time, be as simple as possible. For this reason, the fields of each eCRF will vary depending on the study.
• Data validation system: Sometimes, incorrect data may be entered. Thus, it is important that the tool have a system to detect failures when entering data.
• Information security: The nature of the information collected in the electronic case report forms entails the implementation of security measures that guarantee data confidentiality, integrity and availability, among others. All this should be in line with the legal, regulatory and data security best practice requirements (FDA 21 CRF Part 11, EMA Annex 11, ICH, GDPR, ISO/IEC 27001, etc.) and the risks it may entail should be considered.
• Data export: All data entered in the eCRF will be subsequently analyzed; therefore, it is important that data be exported in formats compatible with the statistical analysis software.
• Reports: Many electronic case report forms have a functionality that allows to generate reports showing significant data about the study development such as the number of patients enrolled, the number of screening failures, etc.
• Warnings: Some eCRFs also include a notification or warning function when a significant event occurs, for example, an adverse event of a patient.

 

“Case report forms are an essential part during clinical research development”

Case Report Form vs electronic CRF: Advantages and disadvantages

As we have already said, electronic case report forms have a lot of advantages compared to their paper predecessors, even though they can also have certain disadvantages. Find below an analysis of their pros and cons:

• Advantages:
  • Time optimization: Data entry is faster than in paper format, since the paper CRFs involve recording data in paper and transferring physically that document to the place where data entry staff are located.
  • Lower failure rate: eCRFs can detect data entered incorrectly and allow the user to correct them.
  • Information entered telematically: In cases where the trials are conducted in sites located in different geographical areas, eCRFs allow entering the information from each site (usually using the Internet) and, at the same time, this information is available immediately for the staff in charge of data cleaning (monitors, data managers, etc.).
  • Data digitization: For the subsequent data analysis, it is essential that data be computerized. The processes will be faster and more efficient with an electronic CRF, since they are entered directly in the database.

• Disadvantages:
  • High costs: Sometimes investigators who develop a clinical trial do not have a very high budget for this and they cannot allow the implementation of an electronic case report form.
  • Training: If an electronic case report form has never been used, it will be necessary to provide a little training in its use to those people who will work with it in order to avoid errors.
  • Design and configuration: Electronic CRFs also require a previous design and configuration to ensure that all the necessary data are collected to assess the study objectives, and that the potential errors that occur when entering data are detected.

The choice between a traditional case report form and an electronic case report form will depend on the research sponsors and their economic resources available. But, overall, the use of an electronic CRF is greatly preferable due to its efficiency and security.

“Electronic case report forms have a lot of advantages compared to their paper predecessors, even though they can also have certain disadvantages”.

Experior, the help you need to manage your CRF

In Experior, as experts in the start-up and management of clinical trials, we can help you to design the case report form that you need for your research. We have the most advanced technology for the successful implementation of an electronic CRF for your research. We customize and adapt CRFs to the largest extent possible to each client.

In addition to the design of case report forms, in Experior we can also help you with the data management of your study at different levels:

• eCRF design.
• Setting and validation of the database.
• Data management plan, that includes a detailed explanation of the data cleaning process.
• Electronic data capture.
• In case of paper CRFs, there is the possibility of double data entry to avoid transcription errors.
• Traceability of data entered (audit record).
• Data cleaning and query management.
• Data coding (for example, adverse event coding using MedDRA).
• Transfer of the database for statistical analysis.
• Database lock to avoid changes in clean data.

In short, we offer a comprehensive service to ensure that the best data quality within the deadlines for the studies. If you need assistance in this, contact us and we will offer you advice.