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:
- Encriptación por SSL: Every communication in the platform is encripted by RSA 2048-bit certificate(SHA2-256) and advanced settings to achieve the highest score (A+) in the SSL Labs security test.
- Restricted access: Restricted access to authorized users with individual passwords, detection system of attempted impersonation with automatic account locking and the platform registers and stores every single action made by the users.
- Access control: Our service allows to configure and manage 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 previous and after value of the variable.
- 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: Digital signature of forms and records, configurable and adaptable 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 responsability with them with the aim to comply the rules of data protection set by the EU. You can find out more about compliance with the EU data protection regulation of AWS.