Books + eBook: Implementation of Clinical Trials Led by Physicians for Pharmaceuticals/Medical Devices
QC review without discrepancies and errors led by companies/physicians - with ready-to-use format included.
【Book + eBook】 For details and applications for this product, please check our website. https://www.science-t.com/ebook/21523.html You can read this popular product at this price only in eBook format! The format is highly praised by monitors and CRCs for its usability in actual fieldwork! For those who find themselves spending too much time on document preparation due to "reconfirmation and revisits due to errors," we present a collection of formats to efficiently reduce workload. <Preventing excessive or insufficient documentation for each item such as protocols, consent forms, and clinical trial summary reports> - Guidelines for protocol creation compared to J-GCP / precise regulatory methods to prevent deviations - Differences in documentation methods between company-led and physician-led studies and materials for addressing each - How to address matters not typically covered in regular medical practice for physician-led clinical trials and the necessary organizational structure 【Pharmaceuticals Edition】 <Included Formats> - Investigational Drug Brochure - Clinical Trial Protocol - Informed Consent Document 【Medical Devices Edition】 <Included Formats> - Clinical Trial Protocol - Case Report Form - Informed Consent Form - Investigational Device Brochure - Clinical Trial Summary Report
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■Authors Akemi Tamaura (National Center of Neurology and Psychiatry, Japan) Yuichi Kamizaki (Medical Device Quality Assurance and Regulatory Affairs Research Group) ■Table of Contents Part 1: Key Document Examples for Physician-Initiated Clinical Trials in Pharmaceuticals Introduction 1. Clinical Trial Drug Overview 1.1 Purpose 1.2 General Information 1.3 Content of the Clinical Trial Drug Overview 1.4 Example of Overview Document 2. Clinical Trial Protocol 2.1 General Information in the Clinical Trial Protocol 2.2 Example of Clinical Trial Protocol 3. Informed Consent Document 3.1 General Information in the Informed Consent Document 3.2 Example of Informed Consent Document 4. Notifications Used in This Chapter Part 2: Key Points for Preparing Essential Documents for Clinical Trials of Medical Devices Centered on Physician Initiatives Introduction 1. Medical Devices and Clinical Trials 2. Clinical Trials of Unapproved Medical Devices 3. Structure and Content of Key Clinical Trial Documents 3.1 Clinical Trial Protocol 3.2 Case Report Form 3.3 Informed Consent Document 3.4 Clinical Trial Device Overview 3.5 Clinical Trial Summary Report Conclusion
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