Submitting a Monograph

Guidelines for Homeopathic Drug Provings

Approved April 2015

9. Monograph Report

  1. Proving Report

This report will include information on Proving design, execution, data collection, analysis, safety, and outcomes. The report should be indexed and formatted in a manner that ensures ease of access and a high degree of usability consistent with Good Clinical Practice guidance (1), (2).
Some elements listed in the ICH Harmonized Tripartite Guideline for Structure and Content of Clinical Study Reports are not applicable to Provings. Excluded or modified elements are listed in the detailed template for this report (Appendix A).
Additional elements that are required by the HPCUS for Proving clinical study reports are detailed in Appendix A.

  1. Monograph Report Submission Process

Questions regarding report format, content, or submission should be directed to the HPUS Editor prior to submission.
All monograph reports should be submitted in their entirety in final form only.
Monograph report should be submitted in electronic version using either locked Microsoft Word or PDF format.
Monograph report should only be submitted directly to the Editor of the HPUS.


(1) International Conference on Harmonization. Guideline for Industry. Structure and Content of Clinical Study Reports (E3). Published July 1996. Last downloaded April 01, 2012 from online at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073113.pdf
(2) HPUS Investigational Proving Substance Report Guidelines for the Monograph Review Committee. Last downloaded April 01, 2012 from online at www.hpus.com

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