Sandoz AE Training

This training will prepare you to report an Adverse Event (AE) while conducting in-home injection training visits for all patients prescribed a medication manufactured by Sandoz . You must take this training and acknowledge that you completed the training prior to conducting in-home injection training visits. There are two modules combined in this training. There are knowledge check questions between the two modules. You must pass with a 100%. After reading each slide thoroughly, click the 'Next' button to advance to the next slide in the training module. When you are ready to begin, please click the 'Next' button below to begin the training.
This training will prepare you to report an Adverse Event (AE) while conducting in-home injection training visits for all patients prescribed a medication manufactured by Sandoz . You must take this training and acknowledge that you completed the training prior to conducting in-home injection training visits. There are two modules combined in this training. There are knowledge check questions between the two modules. You must pass with a 100%. After reading each slide thoroughly, click the 'Next' button to advance to the next slide in the training module. When you are ready to begin, please click the 'Next' button below to begin the training.
Novartis Adverse Event Reporting Form
Novartis Adverse Event Reporting Form
Which of the following statements include an AE? Select all examples that apply
A. After I was administered with Sandoz product X for 4 days I had a skin rash, shortness of breath as well as dizziness.
B. Of the 30 patients treated with HER2 inhibitors, 5 patients developed acneiform rash
C. A patient experienced headache after starting treatment with Sandoz medical device X. However, headache was not suspected to be related to the device.
Which of the following statements includes AE/Complaint with a Medical Device??
A. Some of the asthma patients have complained about severe chest tightness when using Sandoz Medical device
B. A physician reports that a 25-year-old female developed a severe asthmatic attack following failure of Sandoz Albuterol metered-dose inhaler she was using. At the time of reporting the patient's condition had improved following the treatment in hospital.
All of the above
On the evening of May 30th, you are reviewing a Sandoz Program and identify a record from a participant from May 25th where the record mentioned an AE associated with the use/mention of a Sandoz product. You fill in AE form and fax it to Sandoz the next morning when you are back in the office. What is the “Manufacturer Receipt Date” of AE?
May 25th
May 30th
May 31st
Which of the following can be considered as source documents? (check all that apply)
A. Audio recording of a telephone interview
B. Video recording of interviews
C. A piece of paper on which the interviewer has recorded what has happened to the participant
Which of the following are true statements? Select all examples that apply
AER is a mandatory Pharmacovigilance (PV) quality control for programs falling in Group 1 and Group 2 to confirm that all the identified AEs and other reportable scenarios have been transferred to and received by Sandoz PS completely and accurately.
Adverse Event Reconciliation (AER) is performed only for Group 1 programs
Adverse Event Reconciliation is done at the end of all programs, regardless of classification
If a POP lasts for less than 3 months, the monitoring activities are performed once LPLC is achieved.
Yes
No
When should SDV be performed?
Group 1 Programs
Group 2 Programs
In case of any identified non-compliance/actions linked to audit observations/inspection findings or deviations related to AE reporting, at the request of Sandoz
None of the above
Please enter your first and last name.
Please enter the agency that you work for, if you do not work for an agency please put per diem.
Please enter your email address.
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