Submitting a Monograph
Guidelines for Clinical Verification
Approved July 2020
9. Monograph Report
Monograph Reports will vary according to the type of clinical data being provided for monograph review. General requirements for all clinical data submission are provided first, followed by specific requirements and recommendations based upon data type.
- General Requirements
This report will include information on research design, execution, data collection, analysis, safety, and outcomes. The report shall be indexed and formatted in a manner that ensures ease of access and a high degree of usability consistent with health research reporting guidelines and Good Clinical Practice guidance.i
A template (based upon EQUATOR Network guidelines) for this report is provided in Appendix A HPCUS Checklist for Clinical Data submission for Monograph consideration.
- Case Report Requirements
A well reported clinical case report, or series of case reports, creates an opportunity to help develop a coherent homeopathic clinical picture that represents potential homeopathic indications for the IHMP. While all related symptoms must be considered in this process, highly characteristic symptoms play a more significant role due to their specificity, individuation, and consistency with good homeopathic clinical practice.
Case reports must comply with accepted reporting guidelines and their extensions which include those freely available from the Equator-Network.
- Observational Studies
Case reports must comply with accepted reporting guidelines and their extensions which include those freely available from the EQUATOR Network.
- Experimental Trials
Experimental trials must comply with the ICH Guideline for Industry: Structure and Content of Clinical Study Reports (E3)30 and accepted reporting guidelines and their extensions which include those freely available from the EQUATOR Network.
- Monograph Report Submission Process
Questions regarding report format, content, or submission must be directed to the Editor of the HPUS prior to submission.
All Monograph Reports shall be submitted in their entirety in final form only.
All Monograph Reports shall be submitted in electronic version using either locked Microsoft Word or PDF format.
All Monograph Reports shall only be submitted directly to the Editor of the HPUS.
i) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline. Structure and Content of Clinical Study Reports: E3. Current Step 4 version dated 30 November 1995. https://database.ich.org/sites/default/files/E3_Guideline.pdf. Accessed September 10, 2020.