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Performing Source Data Verification (SDV) in a clinical trial involves comparing the data recorded on the Case Report Form (CRF) or electronic equivalent (e.g., eCRF) with the original source documents to ensure accuracy, reliability, and compliance with regulatory requirements. The aim of SDV is to look for three (3) things: Data errors Procedural errors Fraud […]
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Implementing decentralized clinical trials (DCTs) involves leveraging digital health technologies and adapting trial processes to enable remote participation and reduce the need for physical site visits[1]. Here are some steps to consider when implementing decentralized clinical trials: Planning and Design: Strategically plan and design the trial to incorporate decentralized elements. Consider factors such as the […]
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Dealing with unwilling auditees can be challenging, but here are some tips to handle the situation effectively: Establish clear communication: Clearly communicate the purpose and objectives of the audit to the auditee. Explain why their cooperation is important and how it benefits the organization. Build rapport: Try to build a positive relationship with the auditee. […]
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