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 training units 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.

Steps to get access:

1. Register with your GBG study team: study, first name + last name, eMail address and your function in the study are required.
2. You can start the trainings offered on this page at any time.
3. You will receive your access data for the training by eMail.
4. Complete your training with an exercise: upload two document and send them to QC
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 must be saved and be re-named according to the given naming convention.
• 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.

Naming Convention
Each document (regardless of the file format) must be renamed according to certain rules before uploading. The document must be clearly identifiable on the basis of the file name, which includes: study number, document type, version number, date and, if applicable, country, site and name.

The Naming Convention is available here. The specified file name can also be seen for most placeholder under View Details -> Document filed As.

Quality Control by you as uploader
The document itself must be checked according to the ALCOA+ principles before uploading.
The file-name has to be changed according to the naming convention before upload.
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 Workfllow 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 watch the following training videos in the order listed, it is recommended to use the pause function of the video player. The videos have no audio.

It is a good idea to open the training eTMF in parallel and follow the steps directly. Have some dummy pdf documents ready for your training purposes. Please note that documents that have been uploaded to the eTMF (training and study eTMF) cannot be removed.

Please address your question to TMFgbgd