Administrative procedures should be documented and published. Correspondence and data are far less likely to go astray when clear procedures are in place. It is particularly important that all DRA staff have copies of administrative documentation and understand their own role in the procedures.

If pharmaceutical companies have access to the written administrative procedures, they will better understand how to submit applications, whom to contact when they have questions, and how to respond on receipt of correspondence. When they have an inquiry, they can ask more precise and sensible questions. The industry and DRA staff should be informed of the appropriate lines of communication.