Adverse Reaction Report Form For Clinical Trials Natural Health Products Directorate

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

A separate form for each patient adverse reaction must be completed by the sponsor and filed with Health Canada. Please submit adverse reaction reports by fax to the NHPD Clinical Trial Unit at (613) 946-1615. The completed adverse reaction report must be retained by the clinical trial sponsor for a period of 25 years.

Part 1: Administrative / Sponsor Information

Name of Sponsor

Sponsor's Identification No.

Protocol Title

Protocol #
(if known)

Submission Number (if applicable)

Street / Suite / PO Box
City / Town:
Province / State:
Country:
Postal / ZIP Code:

Reported adverse reaction occurred in:
Phase I-III Study:
Phase IV Study:
Other:

Adverse reaction country of origin:
Canada
Other:

Contact for this Clinical Trial
Contact Name
E-mail
Street / Suite / PO Box
City/Town
Province/State
Country
Postal/ZIP Code
Telephone No.
Fax No.

Language Preferred
English
French

Part 2: Patient Information

Patient Identifier

Sex
Male
Female

Height (feet or cm)

Weight (pound or kg)

Age at time of reaction

Part 3 : Adverse Reaction

Outcome attributed to adverse reaction (check all that apply)

Death (yyyy / mm /dd):

Disability

Life threatening

Congenital malformation

Hospitalization

Required intervention to prevent damage / permanent impairment

Hospitalization - prolonged

Other:

Date of reaction (yyyy / mm / dd)

Date of this report (yyyy / mm / dd)

Describe reaction or problem

Relevant tests / laboratory data (including dates yyyy / mm / dd)

Other relevant history, including pre-existing medical conditions (e.g., allergies, pregnancy, smoking or alcohol use, hepatic / renal dysfunction)

Part 4: Suspected Health Product(s)

Name (give labelled strength and manufacturer, if known)
#1
#2

Dose, Frequency & Route Used
#1
#2

Therapy Dates (if unknown, give duration)
From (yyyy / mm / dd ) - To (yyyy / mm / dd)
#1
#2

Indication for use of suspected health product
#1
#2

Reaction abated after use stopped or dose reduced
#1
Yes
No
Not applicable

#2
Yes
No
Not applicable

Lot # (if known)
#1
#2

Expiry Date (if known)
#1
#2

Reaction reappeared after reintroduction
#1
Yes
No
Not applicable

#2
Yes
No
Not applicable

Concomitant health products (name, dose, frequency and route used) and therapy dates (yyyy / mm / dd)

Treatment of adverse reaction (medications and / or therapy), include dates (yyyy / mm / dd)

Part 5: Reporter Information

Name
E-mail
Street / Suite / PO Box
City / Town
Province / State
Country
Postal / ZIP Code
Telephone No.
Fax No.

Occupation

Health professional?
Yes
No

Also reported to manufacturer?
Yes
No