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First Clinical Research Laws, Regulations & Guidelines


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 ICH E1 Guideline - Population Exposure 
 ICH E2A Guideline - Safety Data Management 
 ICH E2B Q&A (R5) – Safety Reports 
 ICH E2C(R1) Guideline – Periodic Safety Reports 
 ICH E2D Guideline - Safety Data Management 
 ICH E2E Guideline - Pharmacovigilance Planning 
 ICH E3 Guideline – Clinical Study Reports 
 ICH E4 Guideline – Dose Response 
 ICH E5 Q&A (R1) – Ethnic Factors 
 ICH E5(R1) Guideline – Ethnic Factors 
 ICH E6 Guideline - Good Clinical Practice 
 ICH E7 – Studies in Support of Special Populations: Geriatrics Q&A 
 ICH E7 Guideline – Geriatrics 
 ICH E8 Guideline - General Considerations 
 ICH E9 Guideline - Statistical Principles 
 ICH E10 Guideline - Control Groups 
 ICH E11 Guideline - Pediatric Clinical Investigations 
 ICH E12A Draft Guideline - New Antihypertensive Drugs 
 ICH E14 Guideline - QT-QTC Intervals 
 ICH E15 - Terminology in Pharmacogenomics 
 ICH Guidance – E3 Structure and Content of Clinical Study Reports Q&A (R1) 
 ICH M3(R1) Guideline - Non-Clinical Safety Studies 
 ICH S6 Guideline - Preclinical Safety Evaluation - Biotechnology 
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