Guide for investigator initiated trials
By: Gerhard Fortwengel ; Isobel Böckler
Publisher: Karger
Published: 2011
Place of publication: Basel
Language: eng
Number of pages: 148
ISBN-13: 9783805596848; 9783805596855
Subjects: Clinical trials; Clinical Trials as Topic; Research Design
Notes: Includes bibliographical references and index.
Table of contents: title: Risk-benefit analysis; title: Study types and study design; title: Investigational medicinal products; title: Study protocol; title: Case report forms; title: Financing; title: Qualifications, CVS of site staff, training, delegation of authority; title: EudraCT; title: Contracts; title: Informed consent; title: Investigator's brochure/summary of product characteristics; title: Insurance; title: Health authority approval; title: Ethics; title: Trial master file, updating and archiving; title: Documentation; title: Data management; title: Screening; title: Pharmacovigilance; title: Patient compliance; title: Source data verification; title: Quality; title: Monitoring; title: Biometry; title: Multicentre trials; title: Final study report and publication.