What is it? Why is it important?

Document identifiers enable documents to be correctly tracked in the study DMS. Ongoing oversight of revised documents ensures that only current and approved documents remain in circulation.

Identifiers include:

  • Document name providing key information on the aim or content of the document
  • Name of author(s)
  • A date when the document was created
  • A version number that designates the current version of the document
  • A release date indicating when the document became valid and mandatory

Additional identifiers can include:

  • Name of persons reviewing, approving and/or releasing the document (e.g. SOPs)
  • Document print date

More

Once a document is no longer in circulation:

  • Its archiving status should be clearly stated
  • The access to archived documents should be restricted in order to prevent that they remain or return into circulation. This would significantly jeopardize the quality, safety and study compliance with regulatory requirements
  • For some quality documents the exact archiving date is documented (e.g. SOPs, WIs, study relevant processes)

What do I need to do?

When developing study documents ensure documents have:

  • An appropriate name related to its use (e.g. protocol, PIS, ICF, delegation-log)
  • A document version number
  • Information on relevant author(s)
  • A date when the document was released and approved for implementation (e.g. define a standardised date format to be used)
  • If applicable, name of staff having reviewed, approved, and released the document (e.g. SOPs)

When making changes to documents, make a distinction between minor and major changes.

Example on how to label document versions:

  • Use a two digit format (e.g. 1.0, 2.0)
  • The 1st digit documents major changes (e.g. 1.0, 2.0, 3.0, 4.0,…)
  • The 2nd digit minor changes (e.g. 1.1, 1.2, 1.3, 2.1, 2.2,…)

Define a responsible person who decides whether a change is major or minor (e.g. SP-INV, Site-INV, author, project manager)

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
  • IC – Inform Consent Form
  • PIS – Participant Information Sheet
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • WI – Working Instructions
Basic ↦ Documents ↦ Document Management ↦ Document Identification
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 ↦ Document Identification

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