Harvard - Thorndike GCRC

Glossary

CAP: Clinical Associate Physician Program

CCI: BIDMC Committee on Clinical Investigation

CDMAS: Computerized Database Management and Analysis System

Clinical Investigation: Medical research devoted solely to studying human subjects.

Co-PI: Co-Investigator:

CTU: Clinical Trials Unit.

GCRC: General Clinical Research Center.

Intercurrent Illness: An illness of a study subject that is unrelated to the research, and expected to be of a short duration.

IRB: BIDMC Institutional Review Board.

JCAHO: Joint Commission on the Accreditation of Healthcare Organizations.

NCRR: National Center for Research Resources.

NIH: National Institutes of Health.

PI: Primary Investigator:

Protocol: A research study.

SAC: GCRC Scientific Advisory Committee

Study Coordinator: The GCRC nurse assigned to be the primary liaison with the PI for each protocol.

Table of Contents

Investigator Manual

I. Environment and Resources

II. Training

III. Personnel

IV. Protocol Submission

V. Policy and Procedure for Investigational Drug Dispensing* Investigational Drug Studies

VI. Investigator Responsibilities

Glossary

Please send general questions about the GCRC and its research programs to the Administrative Manager.
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