SOP for Processing and Reporting of ADR Reports

Purpose

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

Applicability

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

Procedures

Any healthcare professional (Consultant/ junior resident/ senior resident/ paramedical professionals) can report an adverse event to the AMC/NCC.
The ADR reporting form currently uploaded on the CDSCO website MUST be used.
The SOP for filling of ADR form will be followed.
The coordinator/ technical associate or any healthcare professionals associated with the AMCs/NCC are responsible for recording the adverse event information.
A valid case report should have EIGHT minimum criteria as stated in the ADR reporting form guidance.
Check the filled ADR form for the mandatory fields for completeness.
The AMC personnel will ensure completeness and quality of every report.
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.
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.
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.
For each ADR entry generate an internal report in Vigiflow, following submission of report for central assessment and store the electronic copy.

Make an entry in log book for every Vigiflow entry and note the auto-generated worldwide unique number.
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.
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.
A copy of all the ADRs shall be sent to NCC.
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.
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.
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.

REVISION HISTORY

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