CRED Practical Document Writing and Management

24/07/2018

How to distil complicated details in a clear manner

How to distil complicated details in a clear manner

How to distil complicated details in a clear manner

How to distil complicated details in a clear manner

 Remove words that do not contribute any information  Leave out anything that is not a key message and… ● Does not help the reader to grasp the point ● Does not support the key message  Leave out anything that is a key message but… ● Is repetitive ● Includes unnecessary detail

 Review and revise. ● Ensure every:

– Word contributes to the clarity of a sentence – Sentence contributes information to a paragraph – Paragraph contributes to the key message or necessary supporting information in the document – If not DELETE ● Check that the key messages have not been lost ● Ensure that the topics still flow in a logical order

Must dos / Don’t do

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

 Don’t do ● Cut and paste straight from the CSR / 2.7 modules ● Have repetition ● Unnecessary detail ● Exceed recommended length

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