SOP 03 Causality Assessment

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 TRAINING DOCUMENT EFFECTIVITY IMPLEMENTATION DATING Administrative Minor Major N/A Required 30 Days Not Required 15 Days N/A 0 Days Implementation Date: CHANGE HISTORY VERSION NUMBER ISSUE DATE REASON(S) FOR CHANGE

Review History Version No Review date Reviewed and Approved by

DOCUMENT TYPE: STANDARD OPERATING PROCEDURE SOP NO: PvPI/NCC/2011/03 VERSION NO: 01 ISSUE DATE: 22 February, 2011 EFFECTIVE DATE: 23 February, 2011 PURPOSE: Causality assessment of ADR reports Page 2 of 4

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 procedure is to define a process for causality assessment of ADR reports.

2.0

Applicability

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

3.0

Related SOPs: 3.1 3.2

4.0

PvPI/NCC/2011/01 PvPI/NCC/2011/02

Reference: 4.1

The use of the World Health Organization – Uppsala Monitoring Centre (WHO-UMC) system for standardised case causality assessment by WHO-UMC

DOCUMENT TYPE: STANDARD OPERATING PROCEDURE SOP NO: PvPI/NCC/2011/03 VERSION NO: 01 ISSUE DATE: 22 February, 2011 EFFECTIVE DATE: 23 February, 2011 PURPOSE: Causality assessment of ADR reports Page 3 of 4

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 5.2 5.3

The causality assessment shall be performed by using WHO-UMC scale available at the WHO-UMC website (http://www.who-umc.org/graphics/4409.pdf). The AMC coordinator shall perform causality analysis of the suspected ADR. In absence of AMC coordinator, the sub-coordinator along with Technical Associate or any healthcare professionals associated with the AMCs/NCC can also perform causal analysis of the suspected ADR. 5.4 5.5

Ensure that the form has all the ‘Essentially Required Items’ as per the SOP for filling of ADR forms before proceeding to perform the causality assessment. The reporter/ PvPI personnel involved in collection of the particular reports should attempt to acquire all the information for an individual case safety report immediately upon receipt of the suspected event. 5.6 5.7 5.8 5.9

Perform causality assessment for all adverse events reported irrespective of seriousness and expectedness.

After causality assessment has been performed, the AMC coordinator will mention the causal relationship grade in item no: 17 of ADR form and sign the form. These analyzed reports should be sent to the NCC within 07 calendar days through Vigiflow. Follow up reports will be submitted as available.

NCC will review the causality assessment of a sample of cases in accordance with the current version of SOP on Quality Assurance in PvPI.

Note: In case, the coordinator is unable to arrive at a decision regarding the causality

assessment of a particular case, he/she can consult either the reporting physician or physician from the speciality.

DOCUMENT TYPE: STANDARD OPERATING PROCEDURE SOP NO: PvPI/NCC/2011/03 VERSION NO: 01 ISSUE DATE: 22 February, 2011 EFFECTIVE DATE: 23 February, 2011 PURPOSE: Causality assessment of ADR reports Page 4 of 4