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Biotility: Root Cause Analysis
The regulatory requirements outlined in U.S. Food and Drug Administration (FDA) regulations (21 CFR 210 & 211) require Current Good Manufacturing ...
Essentials of Pharmacovigilance
This course provides the basic concepts of pharmacovigilance and materiovigilance, with a focus on the regulatory and practical aspects of postmarket ...
Summit: Study Documents
This course examines the role that essential documents play in a study’s adherence to Good Clinical Practice (GCP) guidelines. It outlines best prac...
Clinical Research Coordinator (CRC) Advanced
The CRC Advanced course provides clinical research professionals with advanced training tailored to the CRC’s critical role in the conduct of clinic...
GDPR & Human Subject Research in the U.S.
The European Union’s (EU) General Data Protection Regulation (GDPR) is in effect and noncompliance penalties are costly. View this webinar and learn...
Participatory Science and the Institutional Review Board
Participatory science—research conducted with or by members of the public—offers powerful opportunities for collaboration, innovation, and communi...
Promoting Statistical Rigor in Scientific Manuscripts: Perspectives of a Statistical Reviewer
Statistical analyses can reveal important patterns in biomedical data, but can also lead to errors. This webinar provides practical advice on issues t...
A Beginner’s Guide to Being a Sponsor-Investigator
This webinar introduces the role of sponsor-investigator in a clinical trial and discusses regulatory and study management responsibilities. It also p...
Clinical Research Associate (CRA)
A foundational course for individuals considering a career as a clinical research associate (CRA). The course provides broad training on the ethical, ...
Paying Participants in Research: Regulations, Ethics, and Practical Considerations
This webinar reviews what is known about participant payment in research, including a review of federal regulations, peer-reviewed literature, and pay...
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