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Adr Reporting Form With Rca and Capa

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100% found this document useful (1 vote)
467 views2 pages

Adr Reporting Form With Rca and Capa

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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“A response to drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of diagnosis or therapy of diseases or for the medication of physiology function.” ADR REPORTING FORM (To be filled by MO} Date of ADR: ‘Time of ADR: Drug reaction on admission: [_] Yes NO ‘Name of Offending Agent Dosage Route & Rate of Administration Batch No. Mfg. Date Expiry Date Was it High Alert Medication? __Yes_| No “Type of ADR: OC Mild 1 Moderate CO Life Threatening Description of Adverse Drug Reaction: Immediate Action T aken : Outcome Recovered Date of recovery /_/ ‘Not Recovered/Unknown/Fatal | Date of Death: —_/__/ Sequel Yes /No If yes, Cause of ADR | aeccribe Name & Signature of person reporting the ADR: Preventive Action Taken: RMO/CONSULTANT Signature Page 1 of 2 Date To Be Filled By Quality Assurance Department Form submission (Date & Time): ADR Number: Form Received By: RCA Required: 0 Yes 2 NO If Yes, detail of RCA with Action Taken RCA Report Corrective Action Taken. Name & Signature of Person who did RCA: Name & Signature of Person who has taken Action: Page 2of 2

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