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Standard Operating Procedures (SOPs)
and Policies

To jump to an SOP-Policies section, click on your choice below:

  1. Purview and Training

  2. Review Mechanisms/Outcomes

  3. Special Requirements

  4. Recordkeeping and External Reporting

  5. Quality Improvement & Assessment

  6. Coordination




1. Purview and Training
a) Determination of Activities That Need IRB Review [C1.0100] [WORD] [PDF] Revised 1/24/14
b) IRB Membership [C1.0150] [WORD] [PDF] Revised 5/16/14
c) IRB Member & Consultant Conflict of Interest [C1.0200] [WORD] [PDF] Revised 11/6/09
d) IRB Members/ORI Staff Training [C1.0250] [WORD] [PDF] Revised 7/8/11
e) Generation, Use, & Revisions of SOPs [C1.0300] [WORD] [PDF] Revised 10/22/10
f) Off-site Research [C1.0350] [WORD] [PDF] Under Revision
2. Review Mechanisms/Outcomes
a) Initial Full Review [C2.0100] [WORD] [PDF] Revised 3/27/17
b) Initial Expedited Review [C2.0150] [WORD] [PDF] Revised 3/13/15
c) Exempt Review [C2.0200] [WORD] [PDF] Revised 7/8/16
d) Continuation Review [C2.0250] [WORD] [PDF] Revised 2/18/12
e) Modification, Deviations & Exceptions-IRB Review of Changes [C2.0300] [WORD] [PDF] Revised 3/29/13
f)

Unanticipated/Anticipated Problem/ Adverse Event Reporting [C2.0350]

[WORD] [PDF] Revised 3/2/16
g) Protocol Violation Review [C2.0400] [WORD] [PDF] Revised 8/19/09
h) HIPAA in Research [C2.0450] [WORD] [PDF] Revised 7/18/11
i) Subject Concerns/Complaints [C2.0500] [WORD] [PDF] Revised 8/19/09
j) Noncompliance [C2.0550] [WORD] [PDF] Revised 9/4/14
k) Termination or Suspension of Research by the IRB [C2.0600] [WORD] [PDF] Revised 7/8/11
l)
Conduct of IRB Meetings [C2.0650] [WORD] [PDF] Revised 7/29/11
3. Special Requirements
a) Informed Consent [C3.0050] [WORD] [PDF] Revised 5/16/14
b) Protection of Vulnerable Subjects [C3.0100] [WORD] [PDF] Revised 2/26/14
c) Medical Device Clinical Investigations , Compassionate Use, and Treatment IDE [C3.0150] [WORD] [PDF] Revised 10/1/13
d) Humanitarian Use Device (HUD) [C3.0200] [WORD] [PDF] Revised 7/20/11
e) Emergency Use [C3.0250] [WORD] [PDF] Revised 5/13/16
f) Expanded Access Program (EAP) for Drugs [C3.0300] [WORD] [PDF] Effective 7/20/11
g) Data and Safety Monitoring Plan [C3.0350] [WORD] [PDF] Revised 7/18/12
h) NCI CIRB Review [C3.0400] [WORD] [PDF] Revised 4/25/14
4. Recordkeeping and External Reporting
a) Minutes of IRB Meetings [C4.0050] [WORD] [PDF] Revised 7/29/11
b) Inspections by Regulatory Agencies [C4.0100] [WORD] [PDF] Revised 7/29/11
c) Mandated Reporting to External Agencies [C4.0150] [WORD] [PDF] Revised 9/4/14
d) Study Closure [C4.0200] [WORD] [PDF] Revised 7/24/15
e) IRB/ORI Recordkeeping [C4.0250] [WORD] [PDF] Revised 7/29/11
5. Quality Improvement & Assessment
a) Directed On-Site Review [C5.0050] [WORD] [PDF] Revised 7/29/11
b) PI Self-Assessment Review [C5.0150] [WORD] [PDF] Revised 8/19/09
c) Administrative Assessment Review [C5.0200] [WORD] [PDF] Revised 5/14/14
6. Coordination
a) Institutional Biosafety Committee (IBC)/IRB Coordination [C6.0100] [WORD] [PDF] Revised 2/15/17
b) Investigational Drug Service (IDS)/IRB Coordination [C6.0350] [WORD] [PDF] Revised 5/8/15
c) Markey Cancer Center (MCC)/IRB Coordination [C6.0400] [WORD] [PDF] Revised 5/5/14
d) Radiation Safety Officer (RSO) Coordination [Use of Radioactive Materials] [C6.0500] [WORD] [PDF] Revised 8/7/09
e) Office of Sponsored Projects Administration (OSPA)/IRB Coordination [C6.0600] [WORD] [PDF] Revised 8/25/14
f) Investigator Conflict of Interest/OSPA/IRB Coordination [C6.0650] [WORD] [PDF] Revised 6/19/13
g) Radioactive Drug Research Committee (RDRC)/IRB Coordination [C6.0750] [WORD] [PDF] Revised 7/24/06
h)

Subject Use and Research Ethics Committee/IRB Coordination [C6.0800]
Suspended until further notice

     
i) Department of Defense IRB/ORI Coordination [C6.0850] [WORD] [PDF]
Revised 7/27/12
j)
Federal Agency “Specific” Requirements IRB/ORI Coordination [C6.0900] [WORD] [PDF] In Effect 10/14/12
k) Center for Clinical and Translational Science IRB/ORI Coordination [C6.0950] [WORD] [PDF]

In Effect 4/8/13

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