CRED Understanding Clinical Development 2024

09/10/2024

What Safety Data Do we Collect

• Adverse events

• Non-serious, Serious

• Laboratory data • Biochemistry (renal/liver), Haematological (red/white cells etc.), Urine analyses • ECG data • intervals, rhythm • Vital sign data • Pulse, Blood pressure, Weight

The Organisation for Professionals in Regulatory Affairs

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Other variables

Age

•

• Elderly

• Paediatrics

Sex

•

Race

•

Genetic variability

•

Smoking

•

Medical history

•

• Inclusion/ exclusion criteria

Concomitant medications

•

The Organisation for Professionals in Regulatory Affairs

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5