www.cspc.in   
 

 
 

 

 

 
 

 
ADVERSE DRUG EVENT REPORTING FORM
 
Name
Age
Sex

Male

Female

Date of Birth (mm/dd/yyyy) Pick A Date
Weight (kgs)
Suspected Adverse Event

Outcome attributed to adverse event (check all that apply)

Death
Life Threatening
Hospitalization - Initial or Prolonged
Disability
Congenital Anomaly
Required intervention to prevent permanent impairment/ damage
Other
Date of event starting (mm/dd/yyyy) Pick A Date
Date of event stopping (mm/dd/yyyy) Pick A Date
Describe event or problem
Relevant tests/ Laboratory data, including date
Other relevant history, including pre-existing  medical conditions ( e.g. allergies,race, pragnancy, smoking & alcohol use, hapatic/ renal dysfunction, etc.)

Suspect Medication (s)

      Name      (Brand and/or generic name)

Labeled Strength Manufacturer Dose Frequency Route used
1.
2.
3.
4.
5.

Therapy dates

From (mm/dd/yyyy)

To (mm/dd/yyyy)

1. Pick A Date Pick A Date
2. Pick A Date Pick A Date
3. Pick A Date Pick A Date
4. Pick A Date Pick A Date
5. Pick A Date Pick A Date

Diagnosis for use (Seperate indications with commas)

1.
2.
3.
4.
5.

Event abated after dose stopped or dose reduced

1. Yes No Not Applicable
2. Yes No Not Applicable
3. Yes No Not Applicable
4. Yes No Not Applicable
5. Yes No Not Applicable

Lot #(if known)

1.
2.
3.
4.
5.

Expiry date (if known) (mm/dd/yyyy)

1. Pick A Date
2. Pick A Date
3. Pick A Date
4. Pick A Date
5. Pick A Date

Event reappered after reintroduction

1. Yes No Not Applicable
2. Yes No Not Applicable
3. Yes No Not Applicable
4. Yes No Not Applicable
5. Yes No Not Applicable
             

Concomitant medical products and therapy dates including self medication & herbal remedies (Exclude those used to treat event)

Clinical (if not the reporter)

Name
Address
Speciality
Phone
E-Mail

Reporter (See confidentiality section below)

Name
Address
Phone
E-Mail
Date of this report (mm/dd/yyyy) Pick A Date

Health Professional

Yes No
Occupation

Also reported to

No one else Manufacturer User facility Distributor
               

If you do not want your identity disclosed to the manufacturer, tick this checkbox