Life-Medea

Regulatory Framework

Life-Medea

Regulatory Framework

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Regulatory Framework

Ethics Committee and Personal Data Protection Agency approvals for implementation of the panel studies in human subjects are required prior patient recruitment. Each partner involved in the human panel studies (UCY, UOC, and SCRC) is responsible for obtaining ethics approval in his or her country. All panel studies of the proposal will meet the criteria of the Helsinki declaration and follow the ICH/GCP and EC rules of good clinical practice. Data from individual countries will be completely anonymized and encrypted prior to sending to the central database. A letter informing about the collection of data via the e-platform and asking for written informed consent for inclusion into the central dataset will be given and signed by patients and or their guardians. In the central database, data protection will be achieved by various means such as data encryption and anonymization. In addition, the Microsoft Azure storage platform that will be used for the purpose of data storage and backup is Health Insurance Portability and Accountability Act (HIPAA) compliant. HIPAA establishes requirements for the use, disclosure, and safeguarding of individually identifiable health information. EnA will be responsible for central data security, storage and backup. Rules will be set to provide datasets to partners for specified analyses. Access to data will only be possible after information and consent of all partners affected.

Receipts of final approvals from Bioethics Committees in Cyprus, Greece and Israel and relevant permissions from the collaborating school and hospital authorities have been obtained (Approvals: EEBK EΠ 2017.01.141, 3.28.223, 7.15.01.23.5).

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