Submitting a Monograph

Guidelines for Clinical Verification

Approved July 2020

2. Personnel Qualifications & Training

Monograph sponsors are advised to seek the expertise necessary to perform well-conducted research regardless of the category of methodology. Specific requirements and recommendations are listed below.

  1. Principal Investigator (PI)

The PI has a minimum of five years of homeopathic clinical practice experience.

The PI has experience or publications that demonstrate a working knowledge of human clinical research.

Prior experience with homeopathic clinical research is recommended.

  1. Homeopathic Clinicians

Homeopathic clinicians include those personnel with a primary role in case-taking, prescribing of the IHMP or data analysis.

A minimum of 200 hours of homeopathic training to include case-taking, case-analysis, and case-management skills is required.

A minimum of one year of homeopathic clinical practice experience or the equivalent in clinical homeopathic training is required for clinicians involved in case management and follow-up of active clinical subjects.

Clinicians treating patients with IHMP must be licensed or certified for medical treatment of patients according to local regulations.

Quality assurance and record-keeping training of clinicians is recommended.

  1. Ethics Training

Ethics training is required when gathering clinical data that requires Ethics Committee or Institutional Review Board (IRB) oversight.

Ethics training shall include:

Training is required for PI and Project Coordinator (if used) within three years of clinical research
Ethics training is required for all personnel to the extent necessary to achieve Ethics Committee or IRB approval
Documented training courses on ethical issues in human clinical research must meet National Institutes of Health (NIH) criteria

(1) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. Procedural October 2009. Accessed September 09, 2020.
(2) National Institutes of Health (NIH). Required Education in the Protection of Human Research Participants. Notice: OD-00-039. Release Date: June 5, 2000. Revised: August 25, 2000. Accessed September 09, 2020.

Foreword Investigational Homeopathic Medicinal Product (IHMP)