Broadcast Memos
|
Regulatory Presentations
|
Policies and
Relevant Regulations
|
Protocol Development Information
|
Regulatory Information
|
Human Subjects Protection (HSP)
|
Protocol Registration
|
Safety and Pharmacovigilance
|
Case Report Form
(CRF) Management
|
|
| Office for Policy in Clinical Research Operations, DAIDS |
| Regulatory Policy Issues |
Mary Anne Luzar, Ph.D
Chief, RAB
Telephone: 301-435-3737
FAX: 301-402-1506
E-Mail: Mluzar@niaid.nih.gov
|
Informed Consent Issues
& Human Subjects
Protection Issues |
Liza Dawson, Ph.D.
Branch Chief, HSPB
Telephone: 301-496-6179
Fax: 301-402-1506
E-Mail: dawsonl@mail.nih.gov
Please CC NIAIDDAIDSHSPB@niaid.nih.gov on all email correspondence.
|
Protocol Registration
Policy Issues |
Melissa Kin, M.S.
OPCRO PRO Team Leader, RAB
Telephone: 301-451-2748
Fax: 301-893-0315
E-Mail: Mkin@niaid.nih.gov |
Expedited and Serious
Adverse Events
Policy Issues |
Ling Chin, M.D.
Safety & Pharmacovigilance Team Leader
Telephone: 301-451-2784
Fax: 301-402-1506
E-Mail: Lchin@niaid.nih.gov
|
| IND Safety Report Issues |
Mary Anne Luzar, Ph.D
Chief, RAB
Telephone: 301-435-3737
Fax: 301-402-1506
E-Mail: Mluzar@niaid.nih.gov
|
| INSIGHT |
Janet O’Brien
International Coordinator, HSPB
Telephone: 301-594-8182
FAX: 301-402-1506
E-Mail: jobrien@niaid.nih.gov
|
| Regulatory Compliance Center |
| Regulatory Documentation |
Arati Kamath, Ph.D.
Telephone: 301-897-7458
Fax: 1-800-275-7619 or 301-897-1710
E-Mail: Regulatory@tech-res.com
Regulatory Hotline: 301-897-1710 |
| Serious Adverse Events |
Anuradha Jasti, M.D.
Telephone: 301-897-7448
Fax: 1-800-275-7619
E-Mail: RCCSafetyOffice@tech-res.com
|
RCC Safety Information Center
(Former Safety Office) |
Dawn Shaw, M.S.
Telephone: 301-897-7426
Fax: 1-800-275-7619 or 301-897-1710
E-Mail: RIC@tech-res.com
Safety Information Hotline: 301-897-1710 |
| Protocol Registration Office |
Martin White, M.S.
Telephone: 301-897-7439
Fax: 301-897-7400
E-Mail: Protocol@tech-res.com
Protocol Registration Hotline: 301-897-1707 |
| CSRC/PSRC |
Heather Juliussen-Stevenson, M.A.
Telephone: 301-897-1715
E-mail: CSRC-RCC@tech-res.com
PSRC-RCC@tech-res.com |
| Clinical Trials Agreement (CTA) Support |
Abe Goldman, J.D.
Telephone: 301-897-1767
E-mail: CTA@tech-res.com
|
| Human Subjects Protection (HSP) |
Kristen Farrell, J.D.
Telephone: 301-897-1751
E-mail: RCC-HSP@tech-res.com
|
| Case Report Form (CRF) Management |
Janet Luczak
Telephone: 301-897-1760
E-mail: crf@tech-res.com
|
|
|
Latest News & Updates
|