Submitting a Monograph
Guidelines for Clinical Verification
Approved July 2020
Adverse Event (AE) – any unexpected, untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Clinical Feature – clinical symptom or sign present in clinical cases of acceptable methodological quality with sufficiently positive outcome after receiving the IHMP.
Characteristic Clinical Feature – clinical feature associated with the IHMP that has strong, peculiar, or highly individualizing qualities.
Clinical Case / Case Series – a single or multiple patient treatment report(s). A study type that describes a patient or patients who have received a similar treatment and a specific outcome or describes a patient or patients with an outcome of interest, regardless of their treatment/exposure.
Ethics Committee or Institutional Review Board (IRB) – an institution-based review board as defined in U.S. federal regulation 45 CFR §46.102.iii
Experimental Trial – a study in which conditions are under the direct control of the PI. The PI determines who is / is not exposed to an intervention that can be repeated, and has a well-defined set of possible outcomes, known as the sample space. An experimental trial can evaluate the potential value of a therapeutic intervention in human subjects using a pre-defined methodology to minimize bias and increase internal validity. The latter can be achieved by random allocation to the treatment, blinding, and other appropriate methods.
Exploratory Analysis – post-hoc data analysis that was not pre-defined but can serve the purpose of hypothesis generation.
Homeopathic Aggravation – is an expected, mild, transient increase in pre-existing signs or symptoms that occurs shortly after IHMP administration, resolves quickly, and is associated with improvement in clinical complaints and / or general health.
Homeopathic Clinical Picture – The constellation of reliable signs and symptoms (clinical features) associated with a homeopathic medicine that are derived from homeopathic provings and/or clinical data and can be applied by a homeopath to select that particular medicine for a patient. The signs and symptoms used to derive this unique image for a homeopathic medicine may be physical, mental, or emotional in nature, and should collectively exhibit inter-relatedness (coherence). The Homeopathic Clinical Picture evolves toward a more complete understanding of the full clinical utility of a homeopathic medicine, as prognostic data (clinical features) are acquired through provings and the homeopathic clinical use of the medicine over time.
Homeopathic Interview – specific techniques for gathering both subjective and objective data according to homeopathic principles, which focus upon understanding the individual’s dynamic, homeostatic balance in response to various internal and external stressors.
Homeopathic Medicinal Product – any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the HPUS and/or the European Pharmacopoeia or, in absence thereof, by an officially recognized national pharmacopoeia.
Informed Consent – a written statement provided to potential subjects regarding the nature of research being conducted. It is the process by which a subject learns about and understands the purpose, benefits, and potential risks of a medical or surgical intervention, including clinical research, and confirms in writing her/his understanding of the risks and benefits of participation and willingness to participate to the study.
Institutional Review Board (IRB) (see under Ethics Committee or Institutional Review Board (IRB))
Interview (see under Homeopathic Interview)
Investigational Homeopathic Medicinal Product (IHMP) – any homeopathic medicinal product not currently monographed in the HPUS that is undergoing human subject testing to increase clinical understanding of the potential risks and utility of the medicinal product.
Likelihood Ratio – a statistical measure that compares the prevalence of a prognostic marker (for instance a characteristic clinical feature) in the medicine responder population to the prevalence of that same marker in the remainder population.
Modality – an environmental, behavioral, or other factor related to a symptom that is associated with either increasing or decreasing the duration, severity, or frequency of that symptom.
Monographs in the HPUS – articulate the specifications of identity and quality for a homeopathic starting material. A monograph for an active ingredient, used in the preparation of a homeopathic drug product, provides a name, definition, and description of the starting material, and first safe attenuations according to intended use; it also provides tests, procedures, and acceptance criteria that constitute the specifications of the starting material or the initially prepared attenuations.
Objective Data – includes any information that is obtained through unbiased observation, physical or psychological examination, or testing of subjects using an external observer. Testing may include laboratory studies, radiologic tests, psychological or other instruments, weight measures, or any other biomarker measurement.
Observational Study – an observational study attempts to draw cause-and-effect relationships from a natural sample where independent variable(s) are not under the control of the investigator. If potential confounding influences are identified in advance, then allowing for them in the design and analysis of the study may be possible. There are numerous possible designs, including so called cohort studies and case-control studies.
Patient Reported Outcome Measure – any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.
Placebo-control – placebo or physiologically inert compound that is indistinguishable from the verum (active medication) used in a clinical study that is not expected to cause any significant mental, physical or emotional reactions in subjects on the basis of its physical/biological properties.
Principal Investigator (PI) – an individual who actually conducts a clinical investigation, i.e., under whose immediate direction and responsibility the test substance is administered or dispensed to subjects or patients. In the event of an investigation conducted by a team of individuals, the PI is the responsible leader of that team. The PI will review and sign-off the final report.
Protected Health Information – individually identifiable health information, held or maintained by a covered entity, or its business associates acting for the covered entity, which is transmitted or maintained in any form or medium (including the individually identifiable health information of non-U.S. citizens). This includes identifiable demographic and other information relating to the past, present, or future physical or mental health or condition of an individual, or the provision or payment of health care to an individual that is created or received by a health care provider, health plan, employer, or health care clearinghouse. For purposes of the Privacy Rule, genetic information is considered to be health information.
Proving – controlled clinical experiment to investigate the potential therapeutic application of a homeopathically prepared medicine. The primary drug discovery tool used in homeopathy as described in the HPCUS Proving Guidelines.
Proving Symptom – expected, mild, transient signs or symptoms occurring within an expected time period after IHMP administration. Such symptoms or signs must be consistent with the current understanding of the symptom picture of the IHMP as derived from and supported by prior proving, toxicological, and/or clinical data.
Randomized Controlled Trials (RCTs) – studies that randomly assign individuals to intervention group or control group(s), in order to measure the effects of an intervention while minimizing the effect of unknown variables.
Red-line Analysis – type of homeopathic analysis using similar symptoms occurring in different parts of the body or mental-emotional sphere that share a common modality or characteristic feature, which helps to describe the homeopathic clinical picture. The technique was first mentioned by Boenninghausen in connection with the creation of general modalities out of particular modalities and can be useful in describing complex dynamical system responses.
Secondary Analysis – evaluation of the relative significance of therapeutic outcomes or prognostic factors other than the primary endpoint of a research study. Such secondary analyses are ideally conducted based on pre-defined criteria.
Serious Adverse Reaction (SAE) – an AE or suspected adverse reaction (SAR) is considered “serious” if, in the view of either the PI or sponsor, it results in any of the following outcomes: Death, a life threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Suspected Adverse Reaction (SAR) – any AE for which there is a reasonable possibility that the IHMP caused the AE.
Suspected Unexpected Serious Adverse Reaction (SUSAR) – an AE or SAR is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. The event is considered a SUSAR if there is cause to suspect a relation to the IHMP administration and the event, and the severity would make the event a SAE.
Verum – active medication that is used in a research trial, as opposed to the placebo or control substance.
i) Yasgur J. Yasgur’s Homeopathic Dictionary and Holistic Health Reference. 2007.
ii) Swayne J (ed.). Churchill Livingstone’s International Dictionary of Homeopathy. London, UK: Churchill Livingstone; 2000.
iii) U.S. Code of Federal Regulations: Title 45—Public Welfare: Subtitle A—Department of Health and Human Services: Subchapter A—General Administration: Part 46: Protection of Human Subjects: Subpart A—Basic HHS Policy for Protection of Human Research Subjects: §46.102 Definitions for purposes of this policy. Electronic Code of Federal Regulations (e-CFR) website. https://www.ecfr.gov/cgi-bin/text-idx?SID=e02f99232d817e78b44daa5ef1b78025&mc=true&node=pt45.1.46&rgn=div5#se45.1.46_1102. e-CFR data is current as of September 8, 2020. Accessed September 10, 2020.