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.
- 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
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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch