If you need an eCRF for clinical trials, contact us at info@zlynger.com
The advantages of electronic CRFs in clinical trials have become very evident in recent years, in the era of digital transformation in which we live.
The use of digital technologies has brought various benefits —particularly related to the speed and efficiency of the processes— and these advantages have also been clearly observed in the use of electronic CRFs for conducting clinical trials.
What is an electronic CRF in clinical trials?
One of the first questions we should ask ourselves is: What is an electronic CRF? The term electronic CRF comes from “case report form”, and is a web-based software application used to collect and store patient data in clinical trials.
Once the term has been defined, let’s move on to comment on the multiple advantages offered by electronic CRFs (eCRFs).
1. eCRFs accelerate data collection
One of the main advantages of eCRFs is that they speed up the data collection process in clinical trials.
Through the use of an electronic CRF, users in charge of entering clinical data from hospitals —usually study coordinators and investigators— use a username and password to enter a web application and insert the data, and in the very moment they are saved, the data is already available to the sponsor’s data management team.
This electronic data entry and its immediate availability substantially improves the old method of using paper CRFs. In the past —and not so long ago, it is still done today— hospital staff filled out the information on paper forms, and these had to be physically sent by courier service to the facilities of the sponsor or its clinical research organization (CRO) assigned. Once these physical documents reached the data center, they had to be manually transferred to the central study database.
Undoubtedly, the use of an electronic CRF makes the process of collecting and storing information in the central database of the clinical study much faster and more efficient.
2. eCRFs optimize monitoring activities
A second important benefit of electronic CRFs is that they greatly facilitate the monitoring tasks of Clinical Research Associates (CRAs), also known as monitors.
CRAs travel and visit hospitals to do source data verification (SDV). The SDV consists of reviewing the hospital’s medical records, the patient’s medical history, including reports and results of medical tests, and verifying if these source data coincide with the data that the hospital has entered in the CRF.
It is convenient for CRAs to do this by looking at the eCRF on their laptop screen. In fact, many electronic CRFs include buttons and mechanisms dedicated to this particular task, which allow marking which data has been verified.
Therefore, the value of an eCRF in monitoring activities is very high and evident.
3. eCRFs accelerate data reviews and cleaning
Just as electronic CRFs speed data entry, they also allow for faster review and cleaning.
Once the hospital staff have entered the information into the eCRF, the CRAs, the data managers, and the sponsor-designated statistical programmers review and work together in a cleaning process.
The people in charge of refining the data check if the information entered in the eCRF is complete and if there are errors or inconsistencies. Normally this is done efficiently using automatic detection mechanisms.
If errors or discrepancies are found in the data, the team that reviews them will prepare and send queries to the hospitals so that these inconsistencies can be corrected. The study coordinators will be able to enter the eCRF and rectify what is needed quickly and comfortably. This cleaning process is repeated until the data has been completely cleaned and the information is considered ready for analysis.
4. eCRFs optimize the execution and re-execution of statistical analyses
When the clinical data have been refined and are ready, it is time to run the statistical analysis and generate the tables, figures and listings that will be included in the scientific publications. This work is carried out by statistical programmers and they usually do it using languages and tools such as SAS or SPSS.
The job of statistical programmers is easier when using an electronic CRF. Since the process of updating and cleaning data is faster and more reliable, statistical programmers can work on the database more quickly and with confidence.
In clinical trials, it is common to have to rerun a statistical analysis after a certain time. In oncology, for example, this is done when the sponsor wants an update of the treatment and follow-up data of the patients, after a number of months has passed. These reanalyses are made more convenient and agile if an eCRF is used.
5. eCRFs improve data security
Data security is extremely critical in any sector and of course it is in the field of clinical research, which involves the use of a patient’s clinical data.
Sponsors must guarantee the security of the data they collect in clinical trials and for this they must use applications with advanced security mechanisms according to international standards.
Electronic CRFs integrate sophisticated security mechanisms to preserve data integrity and recovery. For example, web-based CRFs have an access control module that records which users access the system at any given time. They also have security mechanisms such as the use of a username and password for each authorized person and blocking functions if a user tries to access the system several times without success (to avoid unauthorized or suspicious access). Another security mechanism is the disconnection of a user’s session after a certain period of inactivity.
On the other hand, eCRF solution providers ensure secure hosting of data and corresponding backups, using data centers and professional servers. Sponsors of clinical trials can therefore trust that their data will be protected.
6. eCRFs improve data tracking
Another crucial element of electronic CRFs is their ability to keep a traceable record of the data that is entered and modified in the system.
The mechanism that ensures data traceability is known as audit trail, and it consists of a tool that records the values that are entered in the CRF forms, including who entered them and when. This tool also records the modifications made in a given field, recording both the old and new values, which ensures complete tracking of the information to be analyzed in the clinical trial.
7. eCRFs decrease human manipulation risks
As described above, electronic CRFs optimize data management processes in clinical trials through automation and digitalization. Consequently, this reduces manual data handling, which in turn avoids the risk of errors, loss of information and even fraud.
For example, with the use of an eCRF it is no longer necessary to send the paper forms, avoiding the risk of loss of documents in the shipment. There is also no need for anyone to manually move data from paper documents to the central database, reducing the risk of human error. In addition, electronic traceability systems make it possible to detect if someone has fraudulently modified data.
8. eCRFs enable integration with other systems and data sources
A very interesting benefit of electronic CRFs is that they allow integration with other systems and data sources.
For example, eCRFs can work in conjunction with randomization systems for treatment assignment and medication management (known as IWRS, IRT, or RTSM).
CRF tools also connect with mobile applications that patients use to submit self-generated information (ePRO applications).
On the other hand, it is also possible to use electronic CRFs to import data from other external sources such as laboratory results or data generated by central radiology reviewers (something common in oncology clinical trials).
9. eCRFs improve the global quality of the data sent to regulatory agencies
The technical advantages of electronic CRFs result in an improvement in the quality of the information that is sent to regulatory agencies for evaluation.
Regulatory agencies —such as the Food and Drug Administration (FDA) of the United States— require that the data they receive in drug authorization applications is presented with a specific structure (SDTM standard).
The use of eCRFs facilitate the structuring and standardization of clinical trial datasets, which streamlines the preparation of information for the FDA and other regulatory agencies worldwide.
In summary, the use of electronic CRFs is closely linked to the use of standards required by the competent authorities in charge of evaluating drug marketing applications.
10. eCRFs reduce the overall cost of data management
Through digitalization, process optimization, and the reduction of manual efforts and unnecessary human interaction, electronic CRFs are able to lower the overall costs of a clinical trial at the data management level. This implies financial savings for the sponsor of the study and a reduction of expenses in unnecessary resources.
Conclusion
Electronic CRFs are the present and the future for data management in clinical trials.
The benefits of eCRFs include speeding up data collection, optimizing monitoring activities, and many improvements in information review, cleaning, analysis, security, and traceability.
Additionally, electronic CRFs reduce the risks of human manipulation and allow integration with other systems and data sources.
As a result, sponsors can submit higher-quality data to regulatory agencies while reducing costs.
If you need an eCRF for clinical trials, contact us at info@zlynger.com
