ICH E6(R2) - Clinical Trial Protocol and Protocol Amendment (Chapter 6)
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This program is currently unavailable for enrollment.
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Free Trial CoursesOutline:Course Introduction -Course Overview -What You'll Learn Clinical Trial Protocol and amendment Overview Definitions Other Documents Transfer of Obligations Protocol Sections -Section 6.1: General -Section 6.2: Background Information -Section 6.3: Trial Objectives -Section 6.4:Trial Design -Section 6.5: Selection and Withdrawal of Subjects -Section 6.6: Treatment of Subjects -Section 6.7: Efficacy Assessments -Section 6.8: Safety Assessments -Section 6.9: Statistical Analysis -Section 6.10: Direct Access to Source Data -Section 6.11: Quality Control and Quality Assurance -Section 6.12: Ethics Protocol Sections: Other/ Optional Sections -Section 6.13: Data Handling and Recordkeeping -Section 6.14: Financing and Insurance -Section 6.15: Publication Policy -Section 6.16: Supplemental Sections Conclusion -What We Covered Test Your Knowledge -Results | Objectives:By the end of this course, students will be able to: -Identify clinical trial protocol requirements. -Define protocol compliance. -Provide examples of optional and related protocol documents. -Describe the clinical trial protocol structure. -Discuss the expected information to be included in each individual protocol section. | |
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