CRED Practical Document Writing and Management

Structure

Ad Hoc documents ● The project team will also be handling the questions and answers, request for new information or managing new information that could affect ongoing clinical trials or the overall submission. ● Management of ad hoc documents can be particularly difficult to resource as there are time restraints, resource restraints and often little guidance on the structure of these documents ● The lack of structure can make it difficult to work on but gives a freedom that highly defined structured documents lack. ● Main issue is how to determine how much time and resource level needed compared to other documents which will have internal benchmarking.