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Clinical Research
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
The clinical research associate usually is an inexperienced person with a B.S., pharmacy degree, R.N., or other special scientific medical training. The CRA is involved in the technical aspects of the design and execution of clinical studies and associated data analysis functions. He also assists in support of marketed products. The CRA usually assists, at different levels, in all general functions of drug development. The scope of activities includes initial drafting of protocols and medical reports, and monitoring of studies once they are in progress.
Eating disorders: the journal of treatment and prevention 2020 year in review statement from the editors
Published in Eating Disorders, 2021
Catherine Cook-Cottone, Leslie Karwoski Anderson
Given the vital role that our reviewers play in maintain academic rigor at EDJTP, we also wanted to continue the tradition we started in 2019 of recognizing one reviewer each year who has really gone above and beyond in terms of high quality, timely reviews and contributing to the journal in other ways. This year, we selected Dr. Emilio Compte, PhD., Clinical Research Associate—at Comenzar de Nuevo Treatment Center (Monterrey, México) and Assistant Professor—Universidad Adolfo Ibáñez (Santiago, Chile), to honor as the 2020 EDJTP Reviewer of the Year. Emilio has approached reviewing for EDJTP with enthusiasm and energy since he joined the board in 2017. He is one of our “go-to” reviewers, who we know we can always count on to provide thoughtful, thorough and helpful reviews. It is safe to say that he has had a huge part in improving countless manuscripts through his excellent feedback.
Ethics and etiquette in an emergency vaccine trial. The orchestration of compliance
Published in Global Bioethics, 2020
After graduating, while working as a clinical research associate, I learned that the compliance of people enrolled in clinical studies is of critical importance for researchers and sponsors for two main reasons. First, it is easier to run statistical analysis when participants follow all of the planned procedures without deviations. Second, research institutions that can run trials with high compliance rates are likely to attract other projects. Identifying a per-protocol population allows researchers to present high-quality data to sponsors, and potentially helps a trial advance from an experimental phase to a licensed product on the market. Thus, an ability to execute high-compliance trials is an important performance indicator amongst research units competing for projects.
Can We Define Termination Of Resuscitation Criteria In Out-Of-Hospital Hanging?
Published in Prehospital Emergency Care, 2019
Joséphine Escutnaire, François Ducrocq, Allison Singier, Valentine Baert, Evgéniya Babykina, Cyrielle Dumont, Christian Vilhelm, Jean-Baptiste Marc, Nicolas Segal, Eric Wiel, Pierre Mols, Hervé Hubert
Several quality controls were performed in real-time during data input to detect errors, inconsistencies, or out-of-bound values. Offline tests were performed to detect other types of errors that require verification from the participating MERS. Randomly chosen records were assessed by a clinical research associate to identify other inconsistencies or errors that should be included in the automated tests (on- or offline)