Submitting a Monograph

Guidelines for Homeopathic Drug Provings

Approved April 2015

Table Of Contents

1. FOREWORD
2. PERSONNEL QUALIFICATIONS & TRAINING
   1. Principal Investigator
   2. Project Coordinator / Administrator
   3. Proving Subject Supervisors
   4. Ethics Training
3. INVESTIGATIONAL PROVING SUBSTANCE
   1. Investigational Proving Substance Manufacturer Information
   2. Identity of IPS
   3. IPS Manufacturing Process
   4. Toxicology
   5. Prior Clinical Information
   6. Prior Proving of the IPS
4. DESIGN / METHODS
   1. Overall Study Design and Plan
   2. Controls
   3. Selection of Study Population
   4. Inclusion / Exclusion Criteria
   5. IPS Characteristics
   6. Randomization
   7. Dosing Frequency
   8. Criteria for Non-Repetition of Dose
   9. Blinding
   10. Therapeutic Intervention during Proving
   11. Number of Subjects / Sample Size
   12. Supervisor and Subject Interaction
   13. Definitions to be Included in Proving Timeline
   14. Follow-up period
5. DATA COLLECTION AND RECORD KEEPING
   1. Data Labeling
   2. Data Management
   3. Subject Diary
   4. Supervisor / Principal Investigator Inputs
6. SAFETY ASSURANCE
   1. Adverse Events
   2. Serious Adverse Events
   3. Single Subject Un-blinding in Connection with Adverse Events
   4. Individual Subject Discontinuation from Proving
   5. Event Handling Flow Chart
7. DATA ANALYSIS
   1. Proving Symptoms
   2. Relative Characterizing Features
   3. Characteristic Symptoms
   4. Clinical Synopsis of the IPS
   5. Use of Control Results
8. LEGAL / ETHICS
   1. Ethics or Institutional Review Board
   2. Informed Consent
   3. Subject Withdrawal Criteria
   4. Insurance coverage
   5. Financial Disclosure Certification
9. MONOGRAPH REPORT
   1. Proving Report
   2. Monograph Report Submission Process
10. APPENDIX A
11. GLOSSARY