Clinical Research Guidelines
A companion to the
Textbook on Clinical Research:
A Guide for Aspiring Professionals and Professionals
Second Edition
By Dr. Guru Prasad Mohanta
 
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ICH Guideline
 
ICH Efficacy Testing Guidlines
           
   
Guideline
 Details    
   
E1
   
   
E2A
   
   
E2B(R3)
   
   
E2B(R2)
   
   
E2B Q&A (R5)
   
   
E2C (R1)
   
   
E2D
   
   
E2E
   
   
E2F
   
   
E3
   
   
E4
   
   
E5 (R1)
   
   
E5 Q&A
 Ethnic Factors in the Acceptability of Foreign Clinical Data: Questions and Answers    
   
E6 (R1)
 Good Clinical Practice: Consolidated Guidance    
   
E7
 Studies in support of special populations: Geriatrics    
   
E7 Q&A
 Studies in support of special populations: Geriatrics – Questions and Answers    
   
E8
 General Considerations for Clinical Trials    
   
E9
 Statistical Principles for Clinical Trials    
   
E10
 Issues of Control Group and Related Issues in Clinical Trials    
   
E11
 Clinical Investigation of Medicinal Product in the Paediatric Population    
   
E12
 Principles for Clinical Evaluation of New Anti-Hypertensive Drugs    
   
E14
 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Drugs    
   
E14 Q&A
 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Drugs: Questions and Answers    
   
E15
 Definitions for genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data, and Sample Coding Categories    
   
E16
 Genomic Biomarkers related to Drug Response: Context, Structure and Format of Qualification Submission    
   
     
   
   
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