First Clinical Research Laws, Regulations & Guidelines


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 EMA – ICH E11(R1) Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population 
 ICH E1 Guideline – Population Exposure 
 ICH E2A Guideline – Safety Data Management 
 ICH E2B(R3) – Electronic Transmission of Individual Case Safety Reports – Implementation Guide 
 ICH E2B(R3) Guideline – Safety Reports (Draft) 
 ICH E2B Q&A (R5) – Safety Reports Q&A 
 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 – FDA Guidance – Ethnic Factors in Clinical Data 
 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 Guideline – Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2) (Draft Consensus Guideline) 
 ICH M3(R1) Guideline – Non-Clinical Safety Studies 
 ICH S6 Guideline – Preclinical Safety Evaluation – Biotechnology 
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