eTMF

For certain studies, GBG uses the eTMF neuronOS, which is provided by the company Biomedion.

Here you will find information about the eTMF as well as how to gain access to the eTMF.

• Access to trainings eTMF: https://gbg.neuronos.com/#/gbg-dev/login
• Access for registered users: https://gbg.neuronos.com/#/gbg/login

The eTMF structure is based on the DIA Reference Model adapted for our respective study.

How to get access:

1. Study Group Leader informs GBG eTMF-Team about a new Team Member
2. You will receive your access data for the trainings eTMF via Mail
3. GBG set up a live Session to show how to navigate/upload into the eTMF
4. Completing the training with an exercise after live Training
5. After completing the exercise, you will receive access to the study eTMF

The idea behind the eTMF:
For each document required in a clinical trial, there is a placeholder in the eTMF like an empty envelope into which the document must be uploaded and then subjected to a quality check.

Detailed steps:

• You receive a document or collect it yourself.
• The document (mainly pdf) must pass your quality check.
• The document is then uploaded into the appropriate placeholder (drag and drop) and the document attributes (meta data) are entered.
• The document is sent in the eTMF system to a defined GBG person for the final quality check (four eyes principal).
• The process is completed with the approval of the document.

If the quality of the document is found to be insufficient, it will not pass the quality check. The uploader must make improvements and then re-submit the document for quality check (the rejection reason is viewable in the metadata of the document).

Placeholder List
The placeholder list helps you to find the right placeholder for the document to be uploaded. It gives additional information about the addition to the document name, especially for documents related to site personnel.

Quality Control by you as uploader
The document itself must be checked according to the ALCOA+ principles before uploading.
When uploading, it must be checked that the document is uploaded into the correct placeholder in terms of study, country, site and document type.
Check that the document attributes you enter correspond to the content of the document: date of signature, expiry date or trainings date (last day).
Adapt the (Placeholder) Document Name, if required. Placeholder for e.g. CV PI has to be changed to CV PI Name-of-PI.
When your upload is completed: start the QC Check workflow for your document.

QC Check Workflow in eTMF
The QC Check within eTMF must be performed by a trained person. QC Check of documents uploaded by yourself is not allowed. If you are new to the team, GBG will provide the QC Check person. After your familiarization with the eTMF, a trained team member in your country can perform QC Check, just as you later can perform the QC Check for another team member's uploads in your country.

Please address your question to TMFgbgd