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 | |
Sarah HewittBalay | |
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
| Objective | Timeline |
|---|---|
| List of sources utilised | Q3 2020 |
| List of terms and definitions | Q3 2020 |
| White Paper describing the approach used to standardise the terminology and definitions | Q4 2020 |
|
|---|
Q3/4 2021 |
|---|
|
| 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 | Organisation |
|---|---|
| Bhavna Nanda | Kinapse |
| Devaki Thavarajah | kinapseIndustry |
George Allan | JJanssen Research & JDevelopment |
Helle Gawrylewski | Industry |
Jennie Jennie McGuirk | IconICON |
Lora Killian | Pfizer |
| Mekhala Acharya | Takeda |
Raina Agarwal | Kinapse |
| Sanjay Bagani | Xogene |
| Shannon Lefaivre | Roche |
Sowmya Gabbula | Alnylam Pharmaceuticals |