AE Fields
AE Description
IRRE
What's wrong with this?
Miscellaneous
100
At what ages should the "is patient pregnant" field asked for for all non contraceptive product adverse events?
What is 12-50 years of age
100
If your AE description is too long to fit in the field, you need to add this statement to your AE description?
What is additional text in AE note field
100
Broken or Bent Rod
What is An IRRE & PQC
100
Primary reporter is Nicole Fassbender, RN. AE description reads this: The primary reporter is Physician, Nicole Fassbender.
What is contact types do not match
100
The person reporting the AE information
Who is the primary reporter
200
In the "Hospitalization" field, what else needs to be included in this field if the answer is Yes?
What is Hospital name with city and state of Hospital
200
If your AE description contains more than one product/adverse event/patient, please add a clarifying statement that states what?
What is all drop down boxes refer to....
200
Patient has no adverse symptoms but rod cannot be located
What is a mini IRRE
200
Product selected in the products tab is JANUMET XR and Description is reported as JANUMET
What is AE fields and Product tab not matching
200
AE information was documented in notes on 2/5/2015, AE is filed 2/7/2015
What is a late filed AE
300
If the "Sought medical attention" field is yes, what are some examples of how this field should look?
What is Yes, office visit or Yes, phone call to Physician
300
If a representative learns of an adverse event outside of 24 hours, what needs to be documented in the AE description?
What is confirmed date rep learned of AE is XXXXXXX
300
unable to feel the rod under the skin
What is Unable to palpate
300
THe priamy reporter for this case is the representive, Scott. THe representive learned of this event from the physician Dr. Smith. The representive explained that the patient deviated a rash after using JANUVIA and was therefore administered neurobion topical ointment as treatment. THe rash stopped and the patiend is now recoiled. No further AE information was provided.
What is agent did not check spelling.
300
Caller calls to add new information to an existing AE report
What is AE follow-up information
400
True or False? Any HCPs name can be selected from the MVG box for the "Physician name" field?
What is True
400
Can you find out if there was something wrong with this batch of product that might have something to do with my experience?
Lot check
400
More than 1 rod placed in the same insertion site
What is Multiple insertions in situ
400
Patient reported developing shingles after receipt of ZOSTAVAX. AE filed, and *MED-Adverse Experience-AE* solution is used
What is *MVD AE-VZV Analysis-Adverse Experience-PROQUAD-ZOSTAVAX-VARIVAX-U.S. Reports Only* should be used
400
Appearance of therapeutic benefit or positive effects after use with a product
What is Full AE
500
True or False? For contraceptive AEs, you do not need to ask the "patient's height and weight" question.
What is False
500
What is an example of the first sentence of an AE description that is called in by an internal Merck program employee (access program, PAP etc)
What is Call was reported by Jeanette from the Merck Access program, The primary reporter for this event is the patient.......
500
Rod is present in the patients body, but no longer located at the site it was originally placed
What is migration
500
Patient reports receipt of GARDASIL during pregnancy and mini AE is filed.
What is Full AE is filed for all reports of Merck product use during pregnancy.
500
Patient reports having adverse symptoms after being a part of a clinical trial or after use with a confirmed non-Merck product.
What is AE's that are not reported in the AE screen.