Submitting a Monograph

Guidelines for Homeopathic Drug Provings

Approved April 2015

2. Personnel Qualifications & Training

  1. Principal Investigator

The Principal Investigator has a minimum of 5 years of homeopathic clinical practice experience.
The Principal Investigator has experience or publication that demonstrates a working knowledge of Human Clinical Research.

Prior experience with Provings is recommended.

  1. Project Coordinator / Administrator

Utilization of a Project Coordinator / Administrator to enhance communication, coordination, and control of the Proving is recommended.

  1. Proving Subject Supervisors

A minimum of 200 hours of homeopathic training to include case-taking, case-analysis, and case-management skills is required.
A minimum of 1 year of homeopathic clinical practice experience or the equivalent in clinical homeopathic training for case management and follow-up of active clinical subjects is required.

Quality assurance and record-keeping training of Supervisors is recommended prior to Proving.

  1. Ethics Training

Ethics training is required for all personnel to the extent necessary to achieve Ethics or Institutional Review Board Approval (1).

Ethics training shall include:

a) Training is required for Principal Investigator and Project Coordinator (if used).
b) Documented Training courses on Ethical Issues in Human Research must meet National Institutes of Health criteria or update of similar course within past 3 years (2) (Program examples include: Collaborative Institutional Training Initiative, Harvard School of Public Health course, NIH Protecting human research participants course, or similar).

Recommended for all Supervisors.

(1) Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. U.S. Department of Health and Human Services. Food and Drug Administration. Procedural October 2009. Last downloaded April 01, 2012 from online at

(2) National Institutes of Health Information Notice: OD-00-039.  Required Education in the Protection of Human Research Participants. Last downloaded July 23, 2011. Last downloaded April 01, 2012 from online at

Foreword Investigational Proving Substance