INTERNATIONAL CONFERENCE ON HARMONIZATION -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Site ICH Guidance Documents - Efficacy ICH Guidance Documents - Regulatory Communications Electronic Standards for the Transfer of Regulatory Information (ESTRI)

CPMP PUBLICATIONS -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Topic E1A Population Exposure: The extent of Population Exposure to assess Clinical Safety Topic E2A Good Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Topic E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports Topic E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs Topic E3 Structure and Content of Clinical Study Reports Topic E3 Annex II Structure and Content of Clinical Study Reports - Principal or Coordinating Investigator(s) Signature Topic E3 Annex III Study Design and Schedule of Assessments Topic E3 Annex IVa Clinical Study Reports - Disposition of Patients Topic E3 Annex IVb Clinical Study Reports - Disposition of Patients Topic E3 Annex V Clinical Study Reports - Patients Who Discontinued Therapy Topic E3 Annex VI Clinical Study Reports - Listing of Patients & Observations Excluded from Efficacy Analysis Topic E3 Annex VII Clinical Study Reports - Number of Patients Excluded from Efficacy Analysis Topic E3 Annex VIII Clinical Study Reports - Guidance for Section 11.4.2 Statistical/Analytical Issues Topic E3 Structure and Content of Clinical Study Reports Topic E4 Dose Response Information to support Drug Registration Topic E5 Ethnic Factors in the Acceptability of Foreign Clinical Data Topic E6 Good Clinical Practice Topic E6 Good Clinical Practice Explanatory Note and Comments Topic E7 Studies in support of Special Populations: Geriatrics Topic E8 General Considerations for Clinical Trials Topic E9 Statistical Principles for Clinical Trials Topic E10 Choice of Control Group for Clinical Trials Topic E11 Clinical Investigation of medicinal Products in the Paediatric Population Topic M2 Recommendations on Electronic Transmission of Individual Case Safety Reports Message Specification Topic M3 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Topic M4 Common Technical Document

QUALITY ASSURANCE ORGANISATIONS -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- British Association of Research Quality Assurance (BARQA) European Forum for Good Clinical Practice (EFGCP) Society of Quality Assurance USA