This module describes the procedure for controlling documents. Document control is the Clinical Program’s method of establishing and maintaining critical documents required by the Standards or deemed necessary for the effectiveness of the QM Program. The hierarchy and number of documents or extent of documentation is dependent on the processes, size, and complexity of the Clinical Program and will differ from one program to another.

All controlled documents should be accurate, adequate, accessible, and current.

Objectives:

1. To understand types of controlled documents
2. To understand the document pyramid and the various types of controlled documents.
3. To understand the workflow of creating new documents and revising existing documents.
4. To understand the key components of document management as per JACIE and HTA standards.