As we all know the DIA SC released draft version of EMS process for migrating or transferring the contents or eTMF from one to another eTMF system. This document is already under industries discussion and different stakeholders are keep on watching and providing their valuable input to make it finalize if all agreed.
But question comes in mind:
Why EMS coming into picture??
Whenever any studies gets cancelled or terminated or sponsor needs to change outsourced CROs, then in this situation, sponsor needs TMF into their system or to another CRO system, and even when studies gets completed and Sponsor wanted all eTMF into their system from CROs, then sponsor asks the CRO to map the meta data according to the DIA TMF RM and then transfer happens.
As per the DIA TMF RM EMS process, there are 3 dependencies which is described in draft version of documents.
1. Unique ID
2. Version and
Unique ID is always unique to respective documents (artifacts), and mapping and transferring the documents from source to target eTMF system will be so easy and smooth and even artifacts also plays same roles while mapping and migrating the documents. We talked about version of index that is TMF RM and we supposed to check the version of index before transferring whether source eTMF system using same version of RM as target system, or both system should be same. Is there any exceptional case, when version no is different as source using RM version 1.0, or 1.1 or 2.0 and target is using 3.0 or recently released version 3.1. What will happen when Reference Model version is different and what will be challenges industries will be facing? Still these question will be in draft status until the EMS gets approved from stakeholders.
Indeed this process is going to be so helpful for industries who are facing lot of issues while eTMF migration from one to another system.
Looking forward to see more insight on this.
Thanks and regards,
Sr. eTMF Specialist (India)