CRED Practical Document Writing and Management

Structure

Thinking Process ● To determine what is the document for? ● Documents maybe for internal reporting purposes ● Documents maybe source data/ component for a CTD, CTA, IND, briefing packages, responses to questions, cover letters or other uses. ● Many of these documents have detailed guidance on how to prepare them. Though there will be other with lack of guidance or poor instructions. ● There is also the need to conserve structure of submissions from Agency to Agency as far as possible so a core structure/ content maybe required by the team to ensure the same information has been submitted in each market. ● This maybe the case for clinical trials applications where consistency across the IND, IMPD and other CTA documents is maintained globally.