Author: CIOMS
Edition: 1
Publisher: World Health Organization
Binding: Paperback
ISBN: 9290360801
Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII (A CIOMS Publication)
Regular and timely review appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Medical books Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials. Whereas the overall goal of a clinical development program is to characterize the benefit-risk relationship of the product in a particular patient population, the risk to individual trial subjects is a critical consideration during product development at a time when the effectiveness of a product is generally uncertain. By conducting an overall appraisal of safety data at regular intervals, risks can be recognized thoughtfully assessed and appropriately communicated to all interested stakeholders to support the safety of clinical trial subjects.
Although regulatory authorities currently require the submission of a periodic safety report during the conduct of clinical trials, there are substantial differences in the format content and timing of the different reports. The CIOMS VII Working group is proposing in this new publication an internationally harmonized document namely the Development Safety Update Report (DSUR) that is modeled after the Periodic Safety Update Report (PSUR) for marketed products Medical books Development Safety Update Report (DSUR), Harmonizing the Format and Content for Periodic Safety During Clinical Trials By Council for International Organizations of Medical Sciences (COR). *Author: Council for International Organizations of Medical Sciences (COR) *Series Title: Report of Cioms Working Group *Publication Date: 2006/12/01 *Number of Pages: 203 *Binding Type: Paperback *Language: English *Depth: 0.25 *Width: 6.25 *Height: 9.50
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*Author: Council for International Organizations of Medical Sciences (COR) *Series Title: Report of Cioms Working Group *Publication Date: 2006/12/01 *Number of Pages: 203 *Binding Type: Paperback *Language: English *Depth: 0.25 *Width: 6.25 *Height: 9.50
author cioms author unaids author who author who world health organization unaids author world health organization format paperback language english publication year 17 12 2006 subject medicine subject 2 medical nursing ancillary services title the development safety update report dsur harmonizing the format and content for periodic safety reporting during clinical trials report of cioms working group vii report of cioms working group vii author cioms working group on the development safety upda
Powered by Frooition Pro Click here to view full size. Full Size Image Click to close full size. Development Safety Update Report (DSUR), Harmonizing the Format and Content for Periodic Safety During Clinical Trials - Book NEW Author(s): Council for International Organizations of Medical Sciences Format: Paperback # Pages: 203 ISBN-13: 9789290360803 Published: 12/01/2006 Language: English Weight: 0.90 pounds Brand new book. About Us Payment Shipping Customer Service FAQs Welcome to MovieMars Al
Medical Book Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials
Whereas the overall goal of a clinical development program is to characterize the benefit-risk relationship of the product in a particular patient population, the risk to individual trial subjects is a critical consideration during product development at a time when the effectiveness of a product is generally uncertain. By conducting an overall appraisal of safety data at regular intervals, risks can be recognized thoughtfully assessed and appropriately communicated to all interested stakeholders to support the safety of clinical trial subjects.
Although regulatory authorities currently require the submission of a periodic safety report during the conduct of clinical trials, there are substantial differences in the format content and timing of the different reports. The CIOMS VII Working group is proposing in this new publication an internationally harmonized document namely the Development Safety Update Report (DSUR) that is modeled after the Periodic Safety Update Report (PSUR) for marketed products. It presents the general principles behind the preparation and use of the DSUR and a model DSUR. The model is illustrated with sample fictitious DSURs for a commercial and non-commercial (trial-specific) sponsor.
