ShareCRF complies with the following requirements:
- FDA: 21 CFR Part 11
- EMA: EU GMP Annex 11
- ICH: GCP E6
- GDPR: General Data Protection Regulation
FDA, EMA y GCP
Our electronic CRF complies with the highest requirements of data quality FDA 21 CFR Part 11, EU GMP Annex 11 and GCP E6 in everything related to clinical trials, allowing maximum security for your studies and clinical trials. ShareCRF provides the following functionalities to comply with the indicated regulations:
- SSL Encryption: Every communication in the platform is encrypted by RSA 2048-bit certificate(SHA2-256) and advanced settings to achieve the highest score (A+) in the SSL Labs security test.
- Restricted access: The access is restricted to users authorized with individual passwords. A detection system of attempted impersonation with automatic account locking is in place and the platform registers and stores every single action made by the users.
- Access control: Our service allows configuring and managing the user access, allowing you to define the level of permissions and allowed actions per each user.
- Audit Trail of the data: Every change made in the data collected of the record gets registered in the audit trail, indicating who did it, when and the variable’s value previous and after the change.
- Version control of eCRF: The changes in the structure of the eCRF will be registered as well in the version control of the eCRF.
- Digital signature: Sign digitally any forms and records, configuring and adapting the module to the needs of your study.
The service of ShareCRF will help you to comply with the standards required by the General Data Protection Regulation (UE 2016/679). Our service is prepared to treat as a treatment manager, according to the General Data Protection Regulation.
Our server infrastructure uses AWS (Amazon Web Services) services, and we operate in a shared environment of responsibility with them to comply with the rules of data protection set by the EU. You can find out more about compliance with the EU data protection regulation of AWS.