Abstract: A method and system use a processor, video display and relational database to format, define, generate, maintain, distribute and analyze sets of related documents. The process stores document-specific data in a relational database. A computer-controlled video display guides the document author through the creation and maintenance of the documents, while enforcing the document structure and dependency rules. The creation of documents that relate to activities that require multiple actions at specified time points is driven by a time/action electronic matrix that serves as a central control mechanism for each document set; an example is a document set for use in clinical research studies of drugs.