Submitting a Monograph

Guidelines for Clinical Verification

Approved July 2020

TABLE OF CONTENTS

1. Foreword
2. Personnel Qualifications & Training
   1. Principal Investigator (PI)
   2. Homeopathic Clinicians
   3. Ethics Training
3. Investigational Homeopathic Medicinal Product (Ihmp)
   1. IHMP Manufacturer Information
   2. Identity of IHMP
   3. IHMP Manufacturing Process
   4. Toxicology
   5. Proving Data on the IHMP
   6. Prior Clinical Information
   7. Existing Safety Data
4. Design / Methods
   1. General Requirements
   2. Specific Requirements Cases / Case Series
   3. Specific Requirements for Observational Studies
   4. Specific Requirements for Experimental Trials
5. Data Collection And Record Keeping
   1. General Requirements
   2. Case Series Requirements
   3. Observational Studies
   4. Experimental Trials
6. Safety Assurance
   1. General Requirements
   2. Specific Requirements for Clinical Case Series
   3. Specific Requirements for Prospective Observational Studies
   4. Specific Requirements for Experimental Trials
   5. Adverse Event Determination While Acquiring Clinical Data
7. Data Analysis
   1. General Requirements
   2. Case Reports / Case Series
   3. Observational Studies
   4. Experimental Trials
   5. Pharmacopeia Quality Review Procedure
8. Legal / Ethics
   1. Ethics or Investigational Review Board
   2. Informed Consent
   3. Subject Withdrawal
   4. Insurance Coverage
   5. Financial Disclosure Certification
   6. Ethics Training
9. Monograph Report
   1. General Requirements
   2. Case Report Requirements
   3. Observational Studies
   4. Experimental Trials
   5. Monograph Report Submission Process
10. Glossary Of Terms
11. Appendix A