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The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials, report of CIOMS ... Group VII (Report of Cioms Working Group, 7) - Softcover
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Regular and timely review, appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Whereas the overall goal of a clinical development programme 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 recognised, 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), which 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.
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Regular and timely review, appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Whereas the overall goal of a clinical development programme 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 recognised, 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), which 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.
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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)
Verlag:
World Health Organization, 2006
ISBN 10: 9290360801
ISBN 13: 9789290360803
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