CPHS Policies and Procedures

2018 Requirements (effective 1/21/2019)

These policies and procedures apply to protocols approved on or after January 21, 2019.

Topics	Policies and Procedures	Last Revised
General Administration (GA)	Policies and Procedures Maintenance	1/15/2021
	Training and Education for IRB Members and OPHS Staff	7/18/2023 REVISED
	Training and Education for Investigators	10/10/2022
	Management of OPHS Staff	11/17/2009
	IRB Member Conflict of Interest	1/27/2014
	Signatory Authority	1/21/2019
	Data Security	7/15/2022
	Data Security Guidelines and Matrix	7/2022
	IRB Reliance	11/4/2014
Organization (OR)	Composition of the IRB	5/21/2021
	IRB Membership	1/9/2023 REVISED
	Duties of IRB Members	10/1/2009
Function and Operations (FO)	Research Protocol Submission Requirements	12/20/2011
	Determination of Exemption	4/28/2021
	IRB Meeting Administration	1/21/2019
	Record Retention and Disposition	12/20/2011
Review of Research (RR)	Initial Review	7/29/2021
	Expedited Review	1/21/2019
	Continuing Review	1/21/2019
	Amendment Review	4/6/2022
	Monitoring Ongoing Research	1/21/2019
	Categories of Action	1/21/2019
	Unanticipated Problems and Adverse Event Reporting	9/1/2024 REVISED
	Suspension and Termination of Human Subjects Research	11/20/2013
	Protocol Deviations and Noncompliances	6/30/2023 REVISED
Special Considerations (SC)	Pregnant Women, Fetuses and Neonates	10/1/2009
	Prisoners	6/1/2018
	Children	10/1/2009
Communication and Notification (CO)	Intrainstitutional Communication	1/21/2019
Informed Consent (IC)	General Requirements and Documentation	1/21/2019
	Waivers of Informed Consent	1/21/2019
	Assent and Parent/Guardian Permission	1/21/2019
Quality Assurance (QA)	Review for Purposes of Verification	9/1/2007

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Pre-2018 Requirements

These policies and procedures apply to protocols approved before January 21, 2019.

Topics	Policies and Procedures	Last Revised
General Administration (GA)	Policies and Procedures Maintenance	1/15/2021
	Training and Education for IRB Members and OPHS Staff	7/18/2023 REVISED
	Training and Education for Investigators	10/10/2022
	Management of OPHS Staff	11/17/2009
	IRB Member Conflict of Interest	1/27/2014
	Signatory Authority	11/16/2009
	Data Security	7/15/2022
	Data Security Guidelines and Matrix	7/2022
	IRB Reliance	11/4/2014
Organization (OR)	Composition of the IRB	5/21/2021
	IRB Membership	1/9/2023 REVISED
	Duties of IRB Members	10/1/2009
Function and Operations (FO)	Research Protocol Submission Requirements	12/20/2011
	Determination of Exemption	12/15/2015
	IRB Meeting Administration	5/18/2017
	Record Retention and Disposition	12/20/2011
Review of Research (RR)	Initial Review	7/29/2021
	Expedited Review	5/28/2013
	Continuing Review	8/28/2013
	Amendment Review	4/6/2022
	Monitoring Ongoing Research	9/1/2007
	Categories of Action	5/5/2017
	Unanticipated Problems and Adverse Event Reporting	5/5/2017
	Suspension and Termination of Human Subjects Research	11/20/2013
	Protocol Deviations and Noncompliances	6/30/2023 REVISED
	Grant-Protocol Review	12/20/2011
Special Considerations (SC)	Pregnant Women, Fetuses and Neonates	10/1/2009
	Prisoners	6/1/2018
	Children	10/1/2009
Communication and Notification (CO)	Intrainstitutional Communication	10/1/2009
Informed Consent (IC)	General Requirements and Documentation	5/28/2013
	Waivers of Informed Consent	10/1/2009
	Assent and Parent/Guardian Permission	10/1/2009
Quality Assurance (QA)	Review for Purposes of Verification	9/1/2007