Your Easy Guide to Clinical Studies

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

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As a SP-INV, 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)
• If applicable, the language used in the ICF/PIS
• 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)