Significant Medical/ Surgical History And Physical Examination
If you tick Yes, fill in the follwoing items for each diagnosis. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
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Diagnosis
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Month Year
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Medical condition
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Prior Medication
If you tick ‘Yes’, please record each medication in the following items.
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(Trade name preferred)
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(eg 500 mg)
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(eg BID, PRN)
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Other routes may be entered onto the form when appropriate, and will be coded prior to data entry.
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Indication on Prior Medication page must correlate utilizing the same terminology. Indication on Concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology.
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(e.g. 6 years)
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day month year. If therapy/medication is continuing tick the follwing item.
date
If a medication was marked continuing at the initial visit (on the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.
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