# Acknowledgements - Clinical Study Protocol v1.0.0-ballot2

## Acknowledgements

This IG is sponsored by the [HL7 Biomedical Research and Regulation](https://www.hl7.org/Special/committees/rcrim/index.cfm) work group and was developed under the auspices of the HL7 Vulcan umbrella project, Utilizing the Digital Protocol (UDP), in collaboration with TransCelerate Biopharma, Inc. and CDISC.

Contributing individuals and organizations are:

Current project Leads:

* **Stacy Tegan** - TransCelerate Biopharma
* **Vivian Coombes** - Eli Lilly

Project Technical Lead

* **Hugh Glover** - Vulcan

Core project members:

* **Smita Hastak** – Samvit Solutions
* **Dave Iberson-Hurst** - CDISC, D4K
* **Geoff Low** - Medidata
* **Jimita Parekh** – European Medicines Agency (EMA)
* **Rik Smithies** – NProgram Ltd
* **Panagiotis Telonis** – European Medicines Agency (EMA)

Contribution from the Evidence Based Medicine (EBM) work group and Vulcan Schedule of Activities (SoA) project was greatly appreciated and we recognize those co-chairs:

* **Brian Alper** – EBM
* **Geoff Low** – SoA
* **Mike Buckley** - SoA

Project Management:

* **Robert Ferendo** – TransCelerate Biopharma
* **Shani Sampson** – TransCelerate Biopharma
* **Filippo Napoli** - Vulcan

With contributions from other members who have from time to time, or quietly, participated in meetings, attended conference calls, and supported the core team during the development process.

