2014 Awards
Looking for a doctor? Start your search here:
Use any of the fields below to help narrow your search, then click the "search" button once to see your results.

Policies and Procedures

OPERATING POLICIES AND PROCEDURES
FOR THE
NORTHEAST GEORGIA HEALTH SYSTEM, INC.
INSTITUTIONAL REVIEW BOARD (Ed.4 – 3/4/10)
(NGHS IRB)


Table Of Contents
 

Introduction & Statement Of Principles

Policies & Objectives

  1. NGHS IRB Policies & Procedures
  2. NGHS Board Policy 0-060
  3. Organizational Position
  4. Jurisdiction
  5. NGHS IRB Objectives
  6. Duties & Responsibilities
    1. Northeast Georgia Health System Administration
    2. IRB Coordinator
    3. NGHS IRB
    4. IRB Chair
    5. IRB Members
    6. Researchers/Investigators
    7. IRB Relationships
  7. IRB Composition & Membership
    1. Selection
    2. Membership
    3. Alternate Members
    4. Ad Hoc Members
    5. Tenure
    6. Member Privacy

Operating Procedures

  1. Meetings
    1. Regular Meeting
    2. Called Meeting
    3. Quorum & Voting
    4. Conflict Of Interest
    5. Telephonic Participation
  2. Review Decisions
    1. Approval
    2. Return For Clarification
    3. Disapproval
    4. Suspension or Termination of Approval
  3. Review Categories
    1. Full Board Review
    2. Expedited Review
    3. Facilitated Review
    4. Post Approval Modifications
    5. Continuing Review
  4. Review Processes
    1. Investigator & Site Review
    2. Protocol Review
    3. Informed Consent Review
    4. Consent Documentation Review
  5. Waiver Of Informed Consent
  6. Special Circumstances
    1. Medical Devices
    2. Single Patient Use
    3. Marketed Product Usage
    4. Study Participant Hospitalized At
      NGHS: Study Being Conducted
      Elsewhere
  7. Special Participant Populations
    1. Children
    2. Prisoners
    3. Pregnant Women and Fetuses
  8. Post Approval Procedures
    1. Continuing Review
    2. Adverse Event Reports
    3. Changes In Or From Protocol
    4. Report From FDA Clinical Investigator
      Audit
  9. Reports And Records
    1. IRB Reports To The NGHS Board Of Directors
    2. Other Reports
    3. Records Of NGHS IRB
    4. Record Retention
Text Size
Increase Decrease Reset
Share
Share
Print
Print
Have Questions? Call (770) 219-9000
Follow Us Online
  • Facebook
  • YouTube
  • RSS