Your Easy Guide to Clinical Studies

The purpose of a Document Management System (DMS) is to establish:

• Structures for document filing
• Processes for the creation, ongoing modification, review, release, and archiving of documents

 

A DMS system ensures that:

• Ongoing records are maintained with respect to the creation and modifications of documents
• Only currently approved documents are in circulation and implemented
• Outdated documents are archived in a manner that removes them from the circulation (e.g. restricted access)
• Staff is knowledgeable on how to use the DMS and has ongoing access to current documents

 

In order for a DMS to be effective, the document release process should always be implemented, This guarantees that staff retains ongoing access to current documents, while outdated documents are archived and no longer available.

As a SP-INV establish processes that define how documents are created, reviewed, released and archived.

 

Players involved in these processes are:

• Author(s): is selected based on expertise regarding document aim and content
• Reviewer(s): provides additionally required expertise supporting the author
• Approver: officially approves the document in its final form (e.g. SP-INV, Site-INV, project manager)
• Releaser ensures:
  • Proper document formatting and identification
  • Correct implementation in the DMS of the organisation (e.g. document filing, staff access)
  • In the event of an updated document version, the archiving of the old version

 

Depending on the document, the required processes and players can be adapted or simplified. As a rule, the implementation of SOPs require that all players are involved, while a working document might not need an official review and approve process.