ICH Efficacy and Quality Guidelines
 
  Many new documents have been added to each section, and older documents that have been superseded by new guidelines or final guidelines have been replaced - the site is up to date as of July 17, 1998. Also, all guidelines have been re-labeled to conform to the new ICH guideline classification system (E1 through E9, Q1 through Q6, S1 through S6 etc.), and they have been grouped on each page into the various related sections. All pages now use a color coded tabular format.
 

Information Resources
 
Code 

  Subject of  guideline

 Document Title

 Number of guidelines

  Size 

  Date

  File
 E1 Exposure The Extent of Population Exposure to Assess Clinical Safety
1
 17kb Oct.97
 E2A Clinical Safety  Guideline on Clinical Safety Data Management; Notice
1
 39kb Mar.95
 E2B Clinical Safety  Guidance on Data Elements for Transmission of Individual Case
1
 71kb Jan.98
 E2C Clinical Safety  Guideline on Clinical Safety Data Management: Periodic Safety
1
 51kb May97
 E3 Study Reports  Guideline on Structure and Content of Clinical Study Reports
1
 344kb  Jul.96
 E4 Dose response Dose-Response Information to Support Drug Registration
1
 41kb Mar.94
 E5 Ethic factors Ethnic Factors in the Acceptability of Foreign Clinical Data
1
 58kb Feb.98 
 E6 GCP - Good Clinical Practice Good Clinical Practice: Consolidated Guideline
1
 135kb May97
 E7 Special populations Studies in Support of Special Populations
1
 22kb Jun93
 E8 Clinical trial design Guidance on General Considerations for Clinical Trials
1
 68kb Dec.97
 E9 Statistical considerations  Draft Guideline on Statistical Principles for Clinical Trials
1
 99kb May97
 Q2A Analytical methods Guideline on Validation of Analytical Procedures: Methodology
1
 74kb Nov.97
 Q2B Analytical methods Guideline on Validation of Analytical Procedures: Definitions and Therminology
1
 32kb Mar.97
 *** Additional FDA guidelines  Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research
1
 240kb Oct.97
 
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