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Title: This document lists the scenarios provided as FDA ICSR XML Instance and acknowledgement examples based on FDA ICH E2B(R3) Technical Specifications Document. 
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History of Changes:
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Date                     Version       Description
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Apr 25, 2022          1.0            Initial - Scenarios created
Dec 23, 2022          1.1	     Causality values updated to "Suspected" or "Not Suspected" for Scenario 3 and 4 updated  
		          	     Added acknowledgement samples. 
Jul 29, 2024	      1.2	     Added scenario 8 and correcetd some xml files	

List of Scenarios:
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Scenario 1:  Manufacturer submits postmarket drug report containing 3 drugs that does not include any combination products. There was an Adverse Event. (FAERS2022Scenario1.xml)
  
Secnario 2:  Manufacturer submits postmarket drug report containing 3 drugs where one drug is combination product.There was an Adverse Event and Malfunction. (FAERS2022Scenario2.xml)

Secnario 3:  Manufacturer submits premarket IND safety report containing 3 drugs product where one product is the IND where the AE occured. (FAERS2022Scenario3.xml)

Scenario 4:  Manufacturer submits AGGREGRATE premarket IND safety report with the parent IND number. (FAERS2022Scenario4.xml)

Scenario #5-1:  A person(s) conducting IND-exempt bioavailability/bioequivalence studies submit(s) a premarket safety report containing products from the pre-ANDA where the AE occurred. (FAERS2022Scenario5-1.xml)

Scenario #5-2:  A person(s) conducting IND-exempt bioavailability/bioequivalence studies submit(s) a premarket safety report from the pre-ANDA where the AE occurred. (FAERS2022Scenario5-2.xml)

Scenario #5-3:  A person(s) conducting IND-exempt bioavailability/bioequivalence studies submit(s) a premarket safety report from the pre-ANDA where the AE was observed during the run-in phase. (FAERS2022Scenario5-3.xml)

Scenario 6 :  A mega postmarket instance file, containing all elements. (FAERS2022Scenario6.xml)

Scenario 7:  An example containing a “similar device” malfunction scenario for a device component. (FAERS2022Scenario7.xml)

Scenario 8: Manufacturer submits premarket IND safety report containing 3 drugs product where the premarket IND product not approved and not marketed in US but is marketed outside US where AE occurred

Positive acknowledgement: An example of a positive acknowledgement file. (R3ack-positive.ack) 

Negative acknowledgement: An example of a negative acknowledgement file. (R3ack-negative.ack) 
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