Data Management in Clinical Research –
Clinical research data management is in an evolutionary period because of the improvements in electronic health records, other forms of electronic data capture and harmonization of data collection standards (e.g., CDISC).
Data integrity is a primary requirement in FDA review and approval of a new medical product. The aim is to ensure generalizability of reliable and valid safety and efficacy data.
Develop a detailed Level III discussion posting about clinical research data management (5 paragraphs + references)
Identify and discuss three important issues in data management and how these issues impact the activities of clinical research site personnel and sponsor data monitors.
Search the internet and report on an example of a Data Management SOP. Is this an SOP for a sponsor or a site? Attach and critique the SOP .(STANDARD OPERATING PROCEDURE)
Search the internet and report on an example of a drug that was not approved by the FDA and discuss the key pertinent issues that led to FDA rejection of the NDA application.
Include references and URLs
Criteria Points
Description of three important issues in data management and how these issues impacted site personnel and sponsor data monitors
Description of a data management SOP found on the internet. How does the SOP follow standards for SOP development? (Include URL for the SOP)
Cited example of a drug that failed to achieve FDA approval and a discussion of related factors that prohibited approval
Clarity of presentation, references
