Moher D, Schulz KF, Altman DG for The CONSORT Group. “The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials.” JAMA. 2001. 285:1987-91.
DG Altman, KF Schulz, D Moher, M Egger, F Davidoff, D Elbourne, Peter C. Gøtzsche, and T Lang, MA, for the CONSORT Group. “The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration.” Annals of Internal Medicine, 2001. 134(8), 663-694.
Al Best's summarization of both of the above, in a PowerPoint slide show.
The CONSORT checklist (in MSWord format) or the hot-linked version.
Uniform Requirements for
Manuscripts Submitted to Biomedical Journals
Updated October 2001
Guidelines for Statistical Reporting
E1: Exposure: The Extent of Population Exposure to Assess Clinical Safety
E2: Clinical Safety
E2A: Definitions and Standards for Expedited Reporting
E2B: Data Elements for Transmission of ADR Reports
E2C: Periodic Safety Update Reports
E3: Study Reports
E3: Clinical Study Reports: Structure and Format
E4: Dose Response
E4: Dose-Response Information to Support Drug Registration
E5: Ethnic Factors
E5: Ethnic Factors in the Acceptability of Foreign Clinical Data
E6: GCP
E6: Good Clinical Practice (@EMEA)
Special Populations
E7: Clinical Trials in Special Populations - Geriatrics
Clinical Trial Design
E8: Guidance on General Considerations for Clinical Trials (@EMEA)
E9: Guidance on Statistical Principles for Clinical Trials (@EMEA)
E10: Choice of Control Group (@EMEA)
E11: Clinical Trials in Children
E12: Therapeutic Categories
E12A: Clinical Trials on Antihypertensives
Note For Guidance on the Investigation of Bioavailability and Bioequivalence
Note for Guidance on Clinical Investigation on Medicinal Products in the Treatment of Hypertension
Standard Operating Procedures (SOPs)
Guidance on Good Clinical Practice (CPMP adopted July 96); Explanatory Note and Comments
Concept Papers:
Points to Consider on Biostatistical/Methodological Issues arising from recent CPMP
Discussions on Licensing Applications: Superiority, Non-inferiority and Equivalence
Points to Consider on Biostatistical/Methodological issues arising from recent CPMP discussions on Licensing Applications: Validity and Interpretation of Pooled Analyses, and one Pivotal study
Points to Consider on Biostatistical/Methodological issues arising from recent CPMP discussions on Licensing Applications: Choice of Delta
Position Paper on Biostatistical/Methodological Issues arising from recent CPMP Discussions on Licensing Applications: Missing Data
Points to Consider on Biostatistical/Methodological issues arising from recent CPMP discussions on Licensing Applications: Adjustment for Multiplicity and Related Topics
They do not appear to have anything on-line.
Helsinki: World Medical Association Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects
Listing of Regulatory Bodies