S2W6 Adverse drug reaction (DD)

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What do you need to include in an adverse event report?
Start and end date of event
Serioussness
Severity
Casuality or relationship to investigational medicinal product (IMP)
Outcome
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What makes an adeverse event (AE) serious?
When it meets the 'serious adverse events' criteria
Serioussness relates to the event putcome or action
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What is severity in AE?
Severity relates to the event intensity
Some trials use the common terminology criteria for adverse events (CTCAE) to standardise the definition of severity
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What are some requirements for SAE reporting?
Must be reported within 24 hours of investigator or designee, or site personnel knowledge of event
Follow up SAE information must also be reported within 24 hours of knowledge
The sponsor will report this to MHRA and ethics committee if required
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What are the severity grades of AE?
Grade 1: mild
Grade 2: moderate
Grade 3: severe or medically significant but notlife threatening
Grade 4: life threatening
Grade 5: death related to AE
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What is casuality and outcome in AE?
Casuality refers to the realtionship of the AE to the IMP or other causes. The outcome refers to whether the patient has recovered or not
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What is an adverse drug reaction?
An unwanted or harmful reaction which occurs after the administration of a drug and is suspected or known to be due to the drug.
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Card 2

Front

What makes an adeverse event (AE) serious?

Back

When it meets the 'serious adverse events' criteria
Serioussness relates to the event putcome or action

Card 3

Front

What is severity in AE?

Back

Preview of the front of card 3

Card 4

Front

What are some requirements for SAE reporting?

Back

Preview of the front of card 4

Card 5

Front

What are the severity grades of AE?

Back

Preview of the front of card 5
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