CRED Practical Document Writing and Management

Must dos / Don’t do

 Must dos ● Seek input from key contributors early – Clinical pharmacologist – Clinical lead – Biostatistician – Safety ● Identify key messages ● Present the strengths and limitations of the development program and study results ● Analyse the benefits and risks of the medicinal product in its intended use ● Describe the how the study results support critical parts of the prescribing information ● Provide a critical evaluation of the data