Protocol Synopsis & Evaluation

For Viewing Purposes Only - Licence applicants must use the available WORD or PDF versions of this form when submitting it to the Natural and Non-prescription Health Products Directorate (NNHPD).



  • Date Submitted 
  • HPB use only 
  • Submission Number
  • HPB use only

Trial Title and Number

Background / Rationale

Trial Objectives

Study Design

Study Duration

Number of Sites (inside and outside of Canada)

List of Investigators

Sample Size

Patient Population

Inclusion Criteria

Exclusion Criteria

NHP Formulation

Dosage Regimen

Prestudy Screening and Baseline Evaluation

Treatment Visit

Premature Withdrawal/Discontinuation Criteria

Rescue Medication

Washout Period

Concomitant Medication

Variables to be Assessed

Efficacy Analysis

Safety Analysis

Statistical Analysis

Current Problems/Concerns

Patient Consent Form Evaluation

Requirement Evaluation Status
Full Disclosure of Risk Checkbox Acceptable
Checkbox Requires Revision
Clarity of Language Checkbox Acceptable
Checkbox Requires Revision
Description of Procedure Checkbox Acceptable
Checkbox Requires Revision
Confidentiality for Patient Checkbox Acceptable
Checkbox Requires Revision
Lack of Bias Checkbox Acceptable
Checkbox Requires Revision
Placebo and/or Comparator Disclosure Checkbox Acceptable
Checkbox Requires Revision

Investigatory Brochure Evaluation

Requirement - Version Dated: Evaluation Status
Accuracy of Information Checkbox Acceptable
Checkbox Requires Revision
Rationale for Investigation Checkbox Acceptable
Checkbox Requires Revision
Completeness Checkbox Acceptable
Checkbox Requires Revision
Numerical Data Checkbox Acceptable
Checkbox Requires Revision
Tabulation of Actual Results Checkbox Acceptable
Checkbox Requires Revision
Side Effects Checkbox Acceptable
Checkbox Requires Revision
Summary of ADR: Deaths, Serious, Other Checkbox Acceptable
Checkbox Requires Revision
Information on Patient Exposure, Duration of Study, Location of Study, NHP Dosage Checkbox Acceptable
Checkbox Requires Revision
Dosage Formulation Checkbox Acceptable
Checkbox Requires Revision
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