What is it? Why is it important?

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  • Outdated documents are archived in a manner that removes them from the circulation (e.g. restricted access)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process should always be implemented, This guarantees that staff retains ongoing access to current documents, while outdated documents are archived and no longer available.

What do I need to do?

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
    • 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.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

Abbreviations
  • CTU – Clinical Trials Unit
  • DMS – Document Management System
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
Basic ↦ Documents ↦ Document Management ↦ Purpose
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Documents ↦ Document Management ↦ Purpose

Please note: the Easy-GCS tool is currently under construction.