What Is an Electronic Case Report Form?
If you need an electronic case report form (eCRF), you can contact us at info@klindat.com
“eCRF” are the English initials for “electronic case report form”, which is a software widely used in clinical trials and post-authorization studies, to quickly and reliably collect, clean and process data.
Electronic CRFs have become more popular in recent years and are definitely replacing the less efficient traditional method for collecting data in clinical studies, i.e. the paper-based CRF.
In this article we will explain the technical features and benefits of electronic CRFs, including guidance on their costs.
We hope that this material is useful for clinical trial sponsors, specifically biotech companies, academic research groups and non-profit organizations working with patient registries.
What is an electronic CRF?
An electronic case report form (CRF) can be defined as a web-based software application used to collect, clean, and transfer data in clinical trials and observational studies.
Is it mandatory to use an electronic CRF in clinical research?
No. Clinical trial sponsors are not legally required to use a CRF software, although the use of these tools is nowadays the prevailing trend.
Moreover, electronic CRFs are recent technological tools which weren’t used in the not-too-distant past because clinical trials were conducted without these software systems.
A few years ago, clinical data were collected using paper forms, a data colleting method that is still used today (although their usage is being reduced more and more).
In any case, the benefits of electronic CRFs —in terms of efficiency and convenience— are so obvious that most clinical trial sponsors opt for these platforms (budget permitting).
What are the benefits of using an electronic CRF?
Using an electronic CRF system provides clear advantages when conducting a clinical trial or observational study. In the following lines we will explain the main benefits.
To begin with, using an electronic CRF solution significantly speeds up the data collection and their subsequent processing compared to paper-based data collection.
Hospital users can access the electronic CRF software from any computer and enter data quickly and easily, making the information available to data reviewers right away.
This avoids the hassle of typing and submitting physical paper forms, which entails a major effort, and it is subject to errors.
Secondly, electronic CRF tools facilitate data cleansing. Data cleaning is very important in a clinical study as the information entered into the CRF by hospital users usually contains errors or inconsistencies.
By using an electronic CRF, data managers can easily review the information entered into the system, send queries to sites to resolve discrepancies, and also claim missing data.
Thirdly, an electronic CRF platform ensures the authenticity, integrity, and security of clinical data. This is achieved through advanced mechanisms for access control and traceability of information.
What type of information is collected in electronic CRFs?
Electronic case report forms collect different types of data depending on the clinical trial or observational study therapeutic field.
For example, the following forms, including but not limited to, are typically used in cancer studies:
- demographic data
- medical history
- vital signs
- ECOG performance status
- electrocardiogram data
- biochemistry
- hematology
- coagulation tests
- urinalysis
- pregnancy tests
- adverse events
- concomitant medications
- tumor assessments
- treatment data
- survival follow-up
How is data collected in a CRF application?
A CRF software is usually offered as a web-based application without the need of installing anything else on the computer.
This means that users simply log into the electronic CRF system through a web browser using their usernames and passwords. Each person has a unique, non-transferable username and password for security reasons.
Once logged into the application, users type clinical data into the fields contained in the different forms. It is possible to fill out a form completely at once, or to partially complete it, save it, and continue working on it at another time.
Therefore, data entry in an electronic CRF tool is performed remotely by hospital users —study coordinators and principal investigators— who extract patient data from the source documents (medical records).
How is data from an electronic CRF cleaned?
Once hospital staff have entered clinical data into the CRF web platform, it is time to refine this information by detecting and resolving inconsistencies.
The process of identifying and correcting missing or inconsistent information is known as “data cleaning,” which is a fundamental task in achieving high quality results.
Data cleaning in clinical trials and patient registries is usually performed by the data managers of the company that is in charge of data management (e.g., the staff of a clinical research organization —CRO—).
These data managers will regularly review the information in the electronic CRF and issue queries to hospital users, asking them to clarify and/or correct wrong data.
This process is repeated until all data are complete and error-free, so that they can be exported and analyzed by statisticians and research staff.
How are data transferred from an electronic CRF for analysis?
Once clinical data entered into a CRF system has been cleaned, the next step is to export this information for analysis by statisticians (in collaboration with clinical coordinating investigators).
Electronic CRF applications typically have data export buttons to generate files that, in turn, can be entered into statistical software tools (e.g., SAS, SPSS).
The clinical information contained in electronic CRFs is structured into data sets, and the details of the export processes are documented in advance, early in the clinical study.
How and how often will the data be exported? In what format will the export be done? This information is detailed in the Data Management Plan (DMP).
What advanced features do electronic CRFs have?
CRF software products offer increasingly advanced features that are improved over the years.
Electronic CRF solutions with various mechanisms and functionalities can be found in the market.
The largest electronic CRF manufacturers in the industry have the most powerful systems, as they have been improving their solutions for decades, using accumulated knowledge and feedback from their customers.
Some advanced electronic CRF functionalities include:
- automatic query mechanisms
- automatic coding of medical terms
- customized report generation
- powerful modules for data cleaning
For example, regulatory agencies require adverse events to be coded with the MedDRA dictionary and drugs to be coded with the World Health Organization (WHO) drug dictionary.
Source information is generally entered in free text in the electronic CRF, and a proper coding process for the terms entered is necessary to ensure accurate decisions based on the content of the source term and the related information.
How are electronic CRFs specified and developed?
Electronic CRFs require a concrete and rigorous design and implementation process for each clinical study, as each project has its particular specifications.
Several specification documents must be prepared to record the design and implementation procedures, including a Data Management Plan (DMP) and a document called annotated CRF (aCRF).
A DMP is an essential document that helps data managers and statistical programmers understand what data will be collected in a clinical study and how these data will be collected, stored, cleaned, exported, and analyzed.
An aCRF is a document that maps the fields used to capture patient data to the corresponding variables contained in the Study Data Tabulation Model (SDTM) datasets.
Basically, the process of designing and creating the electronic CRF consists of developing the system specifications and then implementing the software system itself (assembly, testing and validation of the forms and data fields) according to those requirements.
What regulatory requirements must electronic CRF systems meet?
The regulatory requirements that electronic CRF systems must meet have been established in the United States through part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
To achieve regulatory compliance of CRF systems, the following aspects must be ensured:
- Quality and integrity: Measures to ensure quality, accuracy and integrity of data stored in electronic systems.
- User authorization: Security measures to identify the person accessing the application and submitting data, to prevent unauthorized access to the system.
- Traceability and auditing: Measures to ensure that the system keeps a record of the sources from which data originates, who made the changes, when and what information was changed.
- To be attributable: Measures to ensure that data can be retrieved in such a way that all information about each patient in a study is attributable to that patient.
- Data validation: Automated checks performed to ensure the validity and quality of clinical information.
Finally, measures should be implemented to ensure system integrity and data loss protection (e.g., periodic backups).
What are some security and quality mechanisms for electronic CRFs?
CRF systems must have the following mechanisms to ensure data security and traceability: an internal clock (date and time), an access control tool and an activity log.
The internal clock system must correctly display the current date and time so that all activity that takes place in the system is recorded with the actual time.
The application must also have an access control module to track the date and time of each user’s access, the user’s identity, the IP address used, and the type of access (e.g., login, logout, or login error).
In addition, there must be a log to capture the activity performed through the electronic CRF pages.
For each action in the system, data such as subject ID, username, variable name, value inserted, form name, as well as date and time of the action must be recorded.
What is the price of an electronic CRF?
The price of electronic CRF software tools can vary depending on the level of quality and the number of advanced features each system has.
There are a wide variety of electronic CRF options on the market that can meet the needs of different types of studies and sponsors.
Our article “What is the price of an electronic case report form (eCRF)?” will be very helpful to learn more about the costs of a CRF software.
If you need an electronic case roport form (eCRF), you can contact us at info@klindat.com
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