The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled “Electronic Source Data in Clinical Investigations.” This final guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
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Most of the data management centers want to use online entry (eCRF) but the internet is an obstacle specially for ...
Powerpoint slides representing a comprehensive overview of some issues surrounding data management, including an overview of data management, the issue of coding, and regulations and guidelines. NEW ADDITIONS AUGUST 2013: Code of Federal Regulations part 11 - Guidelines on how to implement
Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.
Clinical Data Management: Current status, challenges and future directions from industry perspectives.by Harry van Loen
This publication discsusses whether or not open-source clinical trial data management will improve the likelihood that good clinical trials are conducted in resource-constrained settings.
This article explains the process of data management operations within clinical trials from start to finish.
An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.