The two main requirements in a clinical trial are data quality and data security.
First of all, paper is not the most secure medium. Even if it is true that a handwritten signature cannot be erased, that a file can be sealed… It is impossible to ensure that a document will not be consulted, a paper can be lost, or altered, data can be added or deleted without your knowledge, etc.
An additional factor to remember is the logistical burden of paper on a daily basis: purchasing, ink, printers, storage, archiving… All these steps are complex and costly. The same applies to Excel spreadsheets, which are impractical and unsecured.
Secondly, the quality of a study is inherent to data security. If data security is compromised, then the quality of the study will be directly impacted.
It is therefore essential to be able to trace everything that may have been changed in the data and, if necessary, to determine when this was done and by whom, so as to be sure that the data is correct. This avoids wasting time repeatedly checking the data collected.
1. General security rules
National and international regulations, Datacapt must comply with
The chances of a security breach occurring on an EDC platform are extremely low.
The EDC platform Datacapt uses the latest hosting and development technologies. All data in transit is secured through the use of the SSL/TLS protocol, which ensures the encryption of all data.
The platform itself is hosted under an HDS (Health Data Hosting) certificate with 6 automatic daily backups and outsourced backups every 24 hours.
Datacapt also offers services that comply with the most well-known regulations such as GDPR, HIPAA, and ISO 27001 (Information Security Standards), ensuring the security of data and its use.
Mandatory regulation in the clinical field – electronic data collection
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FDA 21 CRF PART 11
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ICH GCP
This ensures the complete and nominative follow-up of users’ actions in a readable and complete audit trail, the validity of electronic signatures, secure access to the solution, backups, etc…
More information: FDA and European Medicine Agency websites.
2. Security rules: data access
Additional security measures regarding access to data
Datacapt allows you to be flexible with different settings and interfaces, the main objective being security and quality.
You have at your disposal functionalities allowing you to choose precisely the authorisations and the total or partial access of the users to the data. You can decide in real time on the different accesses: studies, data, functionalities…
In this way, you can be sure that all users have access only to the data relevant to them.
Each user must log in with a unique ID and a complex password. The platform records all login attempts and automatically blocks users who force access to the solution. In addition, users must change their passwords every 90 days and cannot reuse old passwords.
On the volunteer side, each participant has access to a personalized and secure interface to find all their documents in one place: eConsent, Questionnaires, and other documents. This interface is secured through personal identifiers (email and complex password).
3. What about data quality?
Now that we have explained the various safety issues in detail, it is appropriate to talk about the quality of the platform and the data. The quality of the data, and thus of the studies, is a crucial point in clinical trials. The quality of a study is linked to many points.
Quality of the data collected
The use of an EDC platform allows you to monitor data collection in real-time and to automatically validate the various entries. These two features are essential for the successful completion of your clinical studies.
Real-time data tracking allows the research team to follow all the responses collected and to have an overview. Data can be reviewed, checked for accuracy, and checked for errors or omissions via an intuitive and easy-to-use interface.
Data validation is an option that can be set on all your questions. By doing so, you will be warned when an answer is inaccurate, wrong, or surprising. Validation also allows you to be notified if a subject needs to be excluded or if a revision of the data entered is required.
By implementing these two functionalities, Datacapt allows you to save precious time. The monitoring and validation of entries have become a major part of the study process and have become indispensable.
1. Design and testing of the survey and forms
Datacapt’s eCRF module allows you to build your study and validate it with test subjects and data. Research teams can then check if their study design is correct, if there are no errors and if the process runs smoothly. This allows for any modifications and revisions before the study is launched.
2. Various export formats are possible
It is entirely possible to export data in various formats so that teams no longer have to make duplicate entries or transcribe data. This avoids errors and saves a lot of time. Datacapt offers you the possibility to export all your data (eCRF, ePRO surveys, consents) in different formats (CSV, PDF, and Excel).
3. Manual or automatic queries
The follow-up of manual or automatic queries is an essential point for the smooth running of your study. When reviewing data or surveys, the investigator can intervene manually if he wishes to raise a query and ask a question. However, the platform can also create automatic queries on different questions.
This feature saves time and increases the quality of your study.
4. Reason of change
Datacapt also incorporates “The reason for change” to comply with good clinical practice. This is an option that, when activated, asks the research team to explain why the original entry was changed. This option is tracked in the audit trail.
5. Audit trail
Finally, the traceability of the data in the audit trail enables all user actions and collected data to be tracked. The audit trail makes it possible to know who made changes, when, and what the old values were.
