Data Integrity
Whether paper or eSource, investigators and sponsors need to ensure that there are adequate controls in place to preserve the confidentiality, integrity, and security of data. Electronic Health Records (EHR) systems need to be assessed by the Sponsor and/or CRO for compliance with regulatory requirements before investigator sites activation, but […]
Maintaining an audit trail is a regulatory compliance requirement, but what makes a good audit trail that is effective and complies with regulations? This article will explain what and audit trail is, what the applicable regulations are and the main aspects to consider when implementing an audit trail to contribute […]