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A Practical Guide to Managing Clinical Trials.

Author: JoAnn Pfeiffer; Cris Wells
Publisher: Milton : Chapman and Hall/CRC, 2017.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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Genre/Form: Electronic books
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Additional Physical Format: Print version:
Pfeiffer, JoAnn.
A Practical Guide to Managing Clinical Trials.
Milton : Chapman and Hall/CRC, ©2017
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: JoAnn Pfeiffer; Cris Wells
ISBN: 9781315299778 1315299771
OCLC Number: 1048925839
Notes: Unanticipated Events.
Description: 1 online resource (325 pages)
Contents: Intro; Half Title Page; Title Page; Copyright Page; Contents; Preface; Acknowledgments; Authors; List of Acronyms; Chapter 1 Rules, Roles, and Responsibilities; GCP, Regulations, and Oversight; Food and Drug Administration; Office of Human Research Protections; International Conference on Harmonisation; Additional Laws and Guidance; Sponsors; Contract Research Organizations; Sponsor Personnel; Investigators; Research Site Personnel; Ethical (Institutional) Review Boards; IRBs and Personnel; A View from India; Regulatory Oversight. The Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 (D & C Act)Schedule Y; Ethical and Regulatory Guidelines; The Clinical Trials Registry (CTRI)-India; Sponsor and Sponsor Personnel; Investigators and Research Site Personnel; Ethical (Institutional) Review Boards, Personnel, and Accreditation; Chapter Review; Apply Your Knowledge; References; Chapter 2 Products, Protocols, and Pretrial Preparation; Drug and Medical Device Development; Investigational New Drug Applications; Investigational Device Exemptions; Sponsor Selection of the Research Sites. Confidential Disclosure AgreementsClinical Trial Feasibility; Foundations of Feasibility; Scientific Review; Regulatory Review; Ethical Review; Resource Review; IRB Applications/Submissions; Essential Documents; A View from India; Investigational New Drugs; Medical Devices; Selection of Research Sites; Accreditation of Research Sites; Confidential Disclosure Agreements; IRB/IEC Submissions; Essential Documents; Chapter Review; Apply Your Knowledge; References; Chapter 3 Sponsor, Site, and Study Start-Up; Research Site Start-Up Responsibilities; Investigator Forms. Other Information Required of the InvestigatorOther Clinical Trial Documents; Investigator Meeting; A View from India; Chapter Review; Apply Your Knowledge; References; Chapter 4 Enticement, Enrollment, and EngagementThe Informed Consent Process; Certificates of Confidentiality; Informed Consent Process; Recruitment and Screening; Screening; Informed Consent Document and Documentation; Consent Documents; Signatures; Vulnerable Subjects; Children; Other Vulnerable Populations; Cognitively Impaired Individuals; Pregnant Women, Human Fetuses/Neonates, and Prisoners. IRB Recruitment Plan of Vulnerable PopulationsHealth Insurance Portability and Accountability Act; Privacy Rule; Security Rule; Ongoing Consent; A View from India; Certificates of Confidentiality; Informed Consent Process; Informed Consent Document and Documentation; Vulnerable Subjects; Children; Pregnant Women, Human Fetuses/Neonates, and Prisoners; Ongoing Consent; Chapter Review; Apply Your Knowledge; References; Chapter 5 From Enrollment to Final Visit; Prescreening; Clinical Trial Visits; Screening Visit; Scheduled Visits; Unscheduled Visits; Final Study Visit; Additional Study Events.

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'"A Practical Guide to Managing Clinical Trials" provides a good introduction to the basics of clinical research for investigators, study coordinators, and other site personnel. The clear writing Read more...

 
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