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.
The eTMF structure is based on the DIA Reference Model adapted for our respective study.
Steps to get access:
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.
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.
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, centre and name.
The Naming Convention is available here. The specified file name can also be seen for each placeholder under View Details -> Document Files As.
Quality Check 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, location and document type.
Check that the document attributes you have to enter correspond to the content of the document.
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.
how to enter and exit eTMF, changing password
description of views and areas and filter options
how to upload a document without adjustment of ‘Expected’ count
how to upload documents and adjustment of ‘Expected’ count
what to do when it has been missed to adjust ‘Expected’ count before last upload
what to do when a document has been rejected in QC
what to do when there is no document for a placeholder or the document can be found in another section/placeholder
information on exercise to gain study eTMF access