Submitting a Monograph

Guidelines for Clinical Verification

Approved March 2018

APPENDIX A: HPCUS Checklist for Clinical Data Submission for Monograph Consideration

The following checklist is provided as an overview of requirements when including Clinical Data for Monograph submission. This checklist should be augmented by referring to the currently available guidelines available on the Equator Network (http://www.equator-network.org/) according to the type of data being submitted.

1. Contact Information
   a. Name, address, contact information for monograph sponsor
2. Synopsis of current data on the Investigational Homeopathic Medicinal Product (IHMP)
   a. Historic use information
   b. Traditional (non-homeopathic) use
   c. Toxicology data
   d. Prior proving data
   e. Existing clinical research data
3. Type(s) of clinical data in Monograph submission
   a. Description of the types of data
   b. Manufacturing process
   c. First safe human attenuation (if known)
4. Qualifications of clinicians / researchers providing data
5. IHMP description
   a. Identifying information
   b. Manufacturing process
   c. First safe human attenuation (if known)
6. Study design
   a. Sufficient description of study design to permit review for potential bias in obtaining data
   b. Reasoning for study design
   c. Clearly defined outcomes
   d. Description of any proposed analysis of data
7. Ethics Committee / IRB approval for research
   a. Copy of letter of approval or waiver for any human subject research
   b. If not conducted, sufficient explanation why such approval not needed according to applicable regulatory requirements where research was conducted
8. Data acquisition
   a. Description of procedure for ensuring safety and continuity of data
   b. Provide contact person and procedure for accessing original data
   c. Description of controls used to ensure subject confidentiality for Protected Health Information (PHI).
9. Safety Assurance
   a. Overview of all safety assurance procedures implemented during the process of data collection and during treatment with the IHMP
   b. Summary listing of all AEs and ADRs
   c. Summary listing of any proving responses or homeopathic aggravations observed during data collection
   d. AE reporting procedures and logs
   e. Description of process used to determine causality for all AEs
   f. Report of all causality determinations
   g. Separate listing of all adverse drug reactions
   h. Listing of any serious adverse events or SUSARs
   i. Report of all therapeutic interventions and outcomes for subjects with AEs
10. Data Analysis
    a. Case reports shall include:
    i. Individual analysis for each case
    ii. Identification of characteristic signs and symptoms
    iii. Aggregate analysis for coherence of cases and homeopathic clinical picture
    b. Observational studies shall include:
    i. Symptom and sign analysis for likelihood of relatedness to IHMP
    ii. Qualitative and/or quantitative evaluations and statistics if indicated
    c. Experimental trials shall include:
    i. Any qualitative and/or quantitative analysis used to evaluate primary outcome measures
    ii. Secondary analysis, if conducted
    d. If multiple forms of data are included, sponsor shall include:
    i. Aggregate analysis of data for coherence and relatedness of outcome data to treatment with the IHMP
11. Monograph conclusions
    a. Assessment of sum data from all sources must be presented in a format that allows the evaluator to help determine if sufficient evidence is present to identify the homeopathic clinical picture likely to respond to treatment with the IHMP.