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 |  Acceptable Requires Revision |
| Clarity of Language | Acceptable Requires Revision |
| Description of Procedure | Acceptable Requires Revision |
| Confidentiality for Patient | Acceptable Requires Revision |
| Lack of Bias | Acceptable Requires Revision |
| Placebo and/or Comparator Disclosure | Acceptable Requires Revision |
Investigatory Brochure Evaluation
| Requirement - Version Dated: | Evaluation Status |
|---|---|
| Accuracy of Information | Acceptable Requires Revision |
| Rationale for Investigation | Acceptable Requires Revision |
| Completeness | Acceptable Requires Revision |
| Numerical Data | Acceptable Requires Revision |
| Tabulation of Actual Results | Acceptable Requires Revision |
| Side Effects | Acceptable Requires Revision |
| Summary of ADR: Deaths, Serious, Other | Acceptable Requires Revision |
| Information on Patient Exposure, Duration of Study, Location of Study, NHP Dosage | Acceptable Requires Revision |
| Dosage Formulation | Acceptable Requires Revision |
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