Submitting a Monograph

Guidelines for Homeopathic Drug Provings

Approved April 2015

5. Data Collection and Record Keeping

Data collection during Provings must be gathered carefully and clarified to ensure proper interpretation of Proving symptoms reported by subjects as information from Provings is translated to clinical practice.

Raw data is generated during the Proving from two primary sources:

  • Subject reporting
  • Examiner / Investigator-gathered data including data from:
    • questioning / interviewing
    • observation
    • biometric testing (if performed)

Data collection and recording occurs in several steps:

  • Before the IPS administration to establish a baseline for interpretation of any symptoms that arise during the test period.
  • During the test period, to record the subject’s experience in their own words.
  • During or after the test period, but before all raw data is sealed, to ensure completeness of symptom data, clarification of any ambiguous symptom data and addition of any objective or test findings.
  1. Data Labeling

Raw data should be limited to symptoms reported by the subjects, clarifying inputs from the investigating team that result from interactions with the subjects and any collected objective data on the subjects. To enhance transparency of the Proving, data sets should be labeled according to their source and source of entry.

Subjects shall record all mental, emotional, and physical symptoms in their own words in the diary format as prescribed before Proving initiation (hereafter referred to as Subject Diary or Subject Entry).

Supervisor and/or Principal Investigator (hereafter referred to as Supervisor or Investigator) inputs occur during or after the Proving period as a result of direct interrogation or examination of the subject, and should help ensure completeness of symptoms and clarify raw data to reduce errors in interpretation.

  1. Data Management

Principal Investigator will ensure that raw data entry will be linked and locked to the source of data:

Electronic formats for data collection are recommended. Written formats are acceptable.

a) Data entry category permission is linked to the appropriate level of input (i.e. subject entries only by subjects, supervisor entry only by supervisors, etc.).
b) Continuity of subject data must be guaranteed (i.e. all data entered for a given subject remains tied only to that subject).
c) All data entered by subjects and supervisors must remain intact as originally entered.

1. Modifications or clarifications must be entered as new data and marked as such.
2. Clarification of raw data entry by members of the investigation team should occur prior to final sealing of data.

d) Once diary information and supervisor inputs are complete, data should be marked as sealed and no further changes to sealed data can be permitted.

Principal Investigator will ensure adequate protection of all Protected Health Information (1).

If applicable, criteria for the exclusion of any raw data from the data collection process must be established prior to Proving initiation.

It is recommended NOT to exclude raw data.

  1. Subject Diary

Subjects shall record all mental, emotional, and physical symptoms in their own words in the diary format as prescribed before Proving initiation. Emphasis should be placed upon the inclusion of all physical, emotional and mental sensations or symptoms that occur.

Initial subject diary entry on a daily basis for at least one week is recommended prior to administration of the IPS to help establish baseline health characteristics.

The time period during and shortly after IPS administration is considered a critical period for data collection.

a) Diary entry shall be at least daily while IPS is administered and for at least 2 weeks after last dose.

b) Diary entries are recommended to continue until all new symptoms or changing symptoms stop occurring.
c) Subject diary entries for new or newly changed symptoms that occur more than 6 weeks after IPS administration are not recommended.

d) Final subject diary entry should occur at the final follow up of the Proving and should be labeled accordingly.

  1. Supervisor / Principal Investigator Inputs

Supervisor / Principal Investigator Inputs are limited to information derived from any of the following sources:

a) Clarification of a symptom reported by the subject after questioning (subjective information to enhance the completeness or clarity of a symptom).
b) Direct examination (such as a physical finding like a rash, or other observations such as the behavior of the subject), if conducted
c) Biomarker testing (such as weight, blood pressure, laboratory analysis, etc.), if conducted

Prior to IPS administration, a case history shall be conducted on each subject.

A full homeopathic interview and examination of each subject is recommended to help develop a clear homeopathic picture of the subject’s baseline state of health.

This shall be conducted in a face-to-face encounter to include:

a) Age
b) Gender
c) Ethnicity
d) Past medical history including hospitalizations, surgical operations, and clinically important birth or genetic defects
e) Present medical history including current medications, other clinically important therapeutic interventions, medication allergies, and current medical conditions in active treatment
f) Prior mental, emotional or physical symptoms or ailments that resulted in treatment.
g) Clinically important symptoms experienced within the past 3 months including notation of strong modalities, peculiar symptoms, or characteristic symptoms.

After IPS administration, Proving data should be collected in accordance with the Proving protocol.

Supervisor input may include objective or subjective information as noted above in this section.

Interactions in person, or via telephone and/or voice or video linkup with subjects during the Proving, are recommended to take place at least weekly during the observation period.

Supervisor shall review all subject diary entries as part of their periodic interview during the Proving period. Investigation and clarification of symptoms should be performed to increase precision of subject reported symptoms. Specific information should be solicited and recorded to include (when present):

a) Body location
b) Time of occurrence
c) Duration
d) Frequency of recurrence or periodicity
e) Severity (using a Likert or ordinal scale defined before Proving initiation)
f) Concomitance with other symptoms
g) Influence of any environmental, physiologic or behavioral factors (also called modalities) upon the symptoms that increase or decrease the severity.
h) Identifiable potential etiologic factors determined by either temporal or presumed causative relatedness to onset of a symptom.

Specific investigation of any symptoms that resemble past complaints, that have recurred or changed after the administration of the IPS, should be conducted to determine severity, duration and frequency relative to status prior to the test period.

Investigation and recording by the supervisor of any observed clinical findings whether or not they were recognized by the subject is recommended.

Pertinent biometric markers including physical examination, laboratory testing, radiologic examination, or other testing may be performed according to Proving design parameters or at the need of the subject. All such objective biometric data should be obtained and recorded by personnel other than Proving subjects.

Pre-defined symptom classification criteria for all subject reported symptoms is required.

Data Categories or Labels for recording are recommended to be utilized for all reported symptoms according to their relationship to the IPS administration (recommended labeling is included in parentheses):

a) New (N)
b) Existing, Unchanged (within expected range of frequency, duration and severity) (U)
c) Changed Existing, Unexpectedly Better / Improved (qualify according to frequency, duration, or severity) (C+)
d) Changed Existing, Unexpectedly Worse (qualify according to frequency, duration, or severity) (C-)
e) Past, Unexpected Recurrence (R)

In person evaluation by the Supervisor or Principal Investigator should be conducted at the final evaluation or exit point of the Proving for each subject.

  1. Record Keeping

Trial record storage will comply with all applicable regulations.

(1) Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule. U.S. Department of Health and Human Services. NIH Publication Number 03-5388. Last downloaded April 01, 2012 from online at

Design / Methods Safety Assurance