PHARMACOVIGILANCE PROGRAMME OF INDIA

NATIONAL COORDINATING CENTRE,

DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

DESCRIPTION OF CHANGE
TYPE OF DOCUMENT
CHANGE

Administrative

Minor

Major

TRAINING

Required

Not Required

N/A

DOCUMENT EFFECTIVITY

30 Days

15 Days

0 Days

IMPLEMENTATION DATING

N/A

Implementation Date:
CHANGE HISTORY

VERSION
NUMBER

ISSUE DATE

REASON(S) FOR CHANGE

Review History
Version No

DOCUMENT TYPE:
SOP NO:
PURPOSE:

Review date

Reviewed and Approved by

STANDARD OPERATING PROCEDURE

PvPI/NCC/2011/02
Processing and Reporting of ADR reports

Page 2 of 5

VERSION NO:

01

ISSUE DATE:

22 February, 2011

EFFECTIVE DATE:

23 February, 2011

PHARMACOVIGILANCE PROGRAMME OF INDIA

NATIONAL COORDINATING CENTRE,
DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

1.0

Purpose
The purpose of this SOP is to define a process for processing and reporting of ADR reports.

2.0

Applicability
This procedure is applicable to those working at the ADR Monitoring Centre (AMC) and National
Coordinating Centre (NCC).

3.0

4.0

Related SOPs:
3.1

PvPI/NCC/2011/01

3.2

PvPI /NCC/2011/03

Reference:
Pharmacovigilance Programme of India

DOCUMENT TYPE:
SOP NO:
PURPOSE:

STANDARD OPERATING PROCEDURE

PvPI/NCC/2011/02
Processing and Reporting of ADR reports

Page 3 of 5

VERSION NO:

01

ISSUE DATE:

22 February, 2011

EFFECTIVE DATE:

23 February, 2011

PHARMACOVIGILANCE PROGRAMME OF INDIA

NATIONAL COORDINATING CENTRE,
DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

5.0

Process/Procedures:

5.1

Any healthcare professional (Consultant/ junior resident/ senior resident/

paramedical professionals) can report an adverse event to the AMC/NCC.

5.2

The ADR reporting form currently uploaded on the CDSCO website MUST be
used.

5.3

The SOP for filling of ADR form will be followed.

5.4

The coordinator/ technical associate or any healthcare professionals associated

with the AMCs/NCC are responsible for recording the adverse event information.

5.5

A valid case report should have EIGHT minimum criteria as stated in the ADR
reporting form guidance (Refer the PvPI - ADR form).

5.6

Check the filled ADR form for the mandatory fields for completeness.

5.7

The AMC personnel will ensure completeness and quality of every report.

5.8

Causality Assessment will be performed and authorized by the Centre

Coordinator/Deputy Coordinator. (As per SOP for Causality assessment of ADR
reports). This activity should not be delegated to the Technical Associate.

5.9

The technical associate will enter the ADR case in Vigiflow after the above
mandatory checks. Case processing in Vigiflow will be done in accordance with
the user manual provided by WHO-UMC. A case which does not meet the criteria
of minimum reporting shall not be entered in Vigiflow.

5.10

After entry of ADR data in Vigiflow, check for completeness of required fields and
check in the report for central assessment to NCC done by AMC.

5.11

For each ADR entry generate an internal report in Vigiflow, following submission
of report for central assessment and store the electronic copy.

5.12

Make an entry in log book for every Vigiflow entry and note the auto-generated
WORLDWIDE UNIQUE NUMBER.

DOCUMENT TYPE:
SOP NO:
PURPOSE:

STANDARD OPERATING PROCEDURE

PvPI/NCC/2011/02
Processing and Reporting of ADR reports

Page 4 of 5

VERSION NO:

01

ISSUE DATE:

22 February, 2011

EFFECTIVE DATE:

23 February, 2011

PHARMACOVIGILANCE PROGRAMME OF INDIA

NATIONAL COORDINATING CENTRE,
DEPARTMENT OF PHARMACOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

5.13

The AMC/NCC personnel will perform adequate follow up with the reporter to
obtain as much information as possible to complete the form, to ensure effective
evaluation of the case. The follow up information will also be reported in Vigiflow.

5.14

The original hard copies of ADR forms entered in Vigiflow will be stored in secure
cabinets designated for this purpose at the centre (AMC/NCC). The access for
these cabinets should be restricted to coordinator, sub-coordinator and technical
associate. The ADR form can be scanned and stored as an electronic copy.

5.15

A copy of all the ADRs shall be sent to NCC.

5.16

Spontaneous reports from the consumers will not be considered as valid ADRs
under the current scope of the PvPI. In case a consumer reports an ADR, the
AMC personnel will make attempts to contact the health care professional of the
patient in order to medically confirm the ADR and obtain adequate information
about it. Every attempt made to follow up will be documented by the AMC.

5.17

The ADR reported from the public health programmes can be reported to the
nearest AMC by any healthcare professionals associated with the public health
programme.

5.18

These ADR data obtained through the Public Health Programme (PHP) shall also
be entered in Vigiflow with the report title beginning with PHP

NOTE:

After the completion of ADR entry in Vigiflow, check in the search and statistics
column (Pooled ADR data) with WORLDWIDE UNIQUE NUMBER for reports
entered at AMC under central assessment.

If the report is not available in pooled ADR data, contact your NCC to check-in the
report in Vigiflow.

DOCUMENT TYPE:
SOP NO:
PURPOSE:

STANDARD OPERATING PROCEDURE

PvPI/NCC/2011/02
Processing and Reporting of ADR reports

Page 5 of 5

VERSION NO:

01

ISSUE DATE:

22 February, 2011

EFFECTIVE DATE:

23 February, 2011