
Strategic Priority # 1: New Services and Training
001 Key Initiative: Implementation of Standards for Clinical Research
Leaders: John I. Gallin, Director, CC
Clinical Center Research Steering Committee
Collaborators: Greg Curt, Clinical Director, NCI
Cliff Lane, Clinical Director, NIAID
Jim Balow, Clinical Director, NIDDK
Ed Liu, Director, Divison of Clinical Sciences, NCI
Elizabeth Nabel, Director of Clinical Research Programs, NHLBI
Purpose/Goal: To assure all NIH Institute intramural programs using the NIH Clinical Center comply with NIH
Standards for Clinical Research
Resources: Each institute must assemble resources to comply with Clinical Research Standards.
CCRSC needs to appoint review teams for IC reviews. A description of materials to be submitted by ICs for review teams needs to be developed.
Timeline: • Initiate IC reviews March 2001; complete reviews June 2002.
Outcomes: • Review all ICs for compliance with Clinical Research Standards
• Improved infrastructure for doing clinical research as measured with surveys of investigators
FY 2001 Key Initiative: Implementation of Standards for Clinical Research
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