Today we feature and infographic that details some of the important EDC features that you should consider when starting a clinical study. Electronic Data Capture systems have become widely adopted, and as more studies transition to remote monitoring activities, they’ve become even more essential. [Click image for full size version]
Here are some factors to consider when choosing a clinical EDC system:
Date storage and retention
- Electronic clinical report forms or eCFRs may need to be stored for long periods of time. Depending on the type of study and post-market surveillance requirement it could be up to 8 or 10 years. The EDC system you choose should securely store these records as long as you need to retain them.
Granular User Permissions and Auditing
- The software should enforce procedures, ensuring that only authorized individuals can sign records of alter data.
- Auditing: A good EDC system will have a continuous audit of every field addition, edit or deletion. You should be able easily see the entire picture of how any data points as been input and has evolved or the course of the study.
High Level security
- The software infrastructure should have safeguards against external treats, such as hacker or viruses, and backup and contingency planning information should be readily available.
- HIPAA Compliance and privacy:
Global Vision Technologies takes security extremely serious. Our team is continually training on the latest security best practices to ensure we are compliant with HIPAA and GDPR regulations. ClinicalPURSUIT contains all of the necessary technical controls, auditing and essential data validation protocols to ensure that your clinical trail software solution is secure and compliant. In addition, GVT maintains both in house staff and external relationships to enable HIPAA compliance regarding security.