 |
* FOCUS Conference
* FERCAP Conference
*
Clinical trials without ethical review under the spotlight
|
|
| The
draft guidelines on the Data and safety monitoring
Boards |
| WHO
TDR Draft DSMB Guidelines-04-03-31,0[1].61 File (MS
Word format .DOC) |
| WHO
TDR Draft DSMB Guidelines-04-03-31,0[1].61 File (PDF
format .PDF) |
| |
Message from the
SIDCER secretariats: |
Dear
Colleagues,
This draft revision of the WHO/TDR Operational
Guidelines for the Establishment and Functioning of
Data & Safety Monitoring Boards (31 March
2004, version 0.16) follows on the meeting organised
at the WHO on 23 -24 October 2003. This revision was
presented and discussed with a large international
audience by me at a special session of the EFGCP &
EMEA Conference on Clinical Research Oversight held
last week in Brussels. The session was co-chaired
by the EFGCP and the European Commission (DG Research).
The draft US FDA Guidance on DMCs (now nearing completion)
was presented in the same session by Dr. Mary Foukes
of the FDA.
We would appreciate receiving your comments on the
revised draft by Wednesday, 15 April. Please send
your comments directly to me (karbwangj@who.int) with a copy to Francis
Crawley at the EFGCP (fpc@efgcp.org).
Juntra Karbwang, MD, PhD
SIDCER secretariat, WHO/TDR |
|
|
|
|
