Transcript Sample Case Report Forms

Group 3:
CASE REPORTING FORMS
The
Job of the reporter must be
simplified
It is the responsibility of the
Pharmacovigilance Center to follow up
and get comprehensive reports
The information required is the
minimum and sure to be available to the
reporter
The reporter should feel comfortable
feeling the form
Send a REPORT save a LIFE
ADVERSE EVENT OR PRODUCT PROBLEM
1. ˸Adverse Event
and/or
˸ Product Problem
2. Describe Event or Problem
Date: ………..…………..
CONFIDENTIALITY OF
INFORMATION
2. Outcomes Attributable to Adverse Even (Tick any / all that apply)
˸ Death(date:……………) ˸ Disability
˸ life-threatening
˸ Congenital Anomaly
˸ Hospitalization
˸ Required intervention to prevent Permanent impairment / damage
˸ Other:………………………………………………………………….…………………………………..
SUSPECT MEDICATION(S) OR PRODUCT
1. Name: ……………………………………………………………………………………………………..
2. Manufacturer Name:…………………………………………………………………………………….
3. Date Drug Administed / product Used…………………………………………………..…………..
Any information related to
the reported and patient shall
be kept confidential
CONTACT US
BY PHONE / Fax / E-MAIL
Phone: …….00000012
fax: 0000000000245
E-mail: [email protected]
Patient Information
1. Hospital Number…………………………………Date……………
Senders Information
Name ………………………………………………………Title:………………..Institution……………………………..….
Contact Address:…………………………………………………………………………………….……….………………..
Contact Phone:……………………………………Fax………….………………..e-mail…………………..……………….
Congratulations
You have
Saved a LIFE
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Public Health Services
Food and Drug Administration
Cape Town
NO POSTAGE
NECESSARY
Official Business
Penalty for Private use $300
BUSINESS REPLY MAIL
FIRST CLASS MAIL
PERMIT NO. 123
CAPE TOWN
Cape Town Pharmacovigilance Center