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PREGNANCY REPORT FORM Guidelines for completion
Pregnancy Report Form completion guidelines v.2.0 – 15-Dec-2015 Page 8 of 9 In the event of an SAE in the foetus/child (e.g. spina bifida), an SAE Report Form should record the serious child’s event with the patient being the child.
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SERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines …
endtb.orgSERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines for completion SAE Report Form completion guidelines v.2.0– 15-Dec-2015 Page 7 of 11 The numbering (SAE 1, SAE 2, SAE 3) allows for causality assessment in section 3.5. Adverse event term for cases of overdose should be ZOverdose of [Drug name].
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