Project Scope |
Currently there is inconsistency in terminology used in the field of data sharing and disclosure. These inconsistencies exist across industry and regulatory agencies as well as within PHUSE and cause unnecessary confusion. This project aims to collect, align |
and standardise terminology and their definitions used in future deliverables. Previous PHUSE deliverables as well as key publications in the field, will be examined to create proposal for baseline list of terms and definitions to be used moving forward. |
Project Leads |
|---|
Lukasz Kniola |
Balay |
Lauren White (PHUSE Project Coordinator) |
| Objectives and Deliverables | Timelines |
|---|---|
| Publish first set of terms, definitions and guidance (White Paper) | Q2 2021 |
| Publish remaining terms and definitions | Q2 2021 |
Key Milestones
|
|---|
Listing terms and definitions and categorised Terminologies.
|
| Published Deliverables | Date |
|---|---|
| Terminology Harmonisation in Data Sharing and Disclosure Deliverables Guidance V2 (Version 2) | 3-Nov-2021 |
| Terminology Harmonisation in Data Sharing and Disclosure Deliverables Terms and Definitions (Template Link) (Version 2) | 3-Nov-2021 |
| Terminology Harmonisation in Data Sharing and Disclosure Guidance (Version 1) | 19-May-2021 |
| Terminology Harmonisation in Data Sharing and Disclosure Terms and Definitions (Version 1) | 19-May-2021 |
Project Members |
|---|
Project Members
| Organisation | |
|---|---|
| Bhavna Nanda | Kinapse |
| Devaki Thavarajah |
| Industry |
George Allan |
| Janssen Research & Development |
Helle Gawrylewski |
| Industry |
Jennie McGuirk |
ICON | |
Lora Killian | Pfizer |
| Mekhala Acharya |
| Takeda |
Raina Agarwal |
| Kinapse | |
| Sanjay Bagani | Xogene |
| Shannon Lefaivre | Roche |
Sowmya Gabbula |
| Alnylam Pharmaceuticals |