Clinical Trials Office Standard Operating Procedure
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Chapter 1 : Administrative
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Section A : Administrative
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10.01.3 : Developing Standard Operating Procedures
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10.02.3 : Revising Standard Operating Procedures
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10.03.3 : Distributing New & Revised SOPs
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10.04.2 : Quality Review of SOPs
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10.05.3 : Clinical Research Coordinator Orientation
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10.06.3 : Responsibilities of the Research Team
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10.07.2 : Management of Clinical Trial Regulatory Files
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10.08.1 : Communication w/ CT Sponsor or CRO
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Chapter 2 : Pre-Study
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Section 2 : Pre Study Content
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20.01.2 : Assessment of Protocol Feasibility
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20.02.3 : Preparation of Initial CT Submission to Institutional Review Board - Health Sciences Research (IRB-HSR)
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20.03.3 : Development of an Informed Consent Form
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20.04.5 : Preparation of a Clinical Trial Budget
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20.05.3 : Pre-Study Site Evaluation Visit
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20.06.2 : Site Initiation Meeting
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20.07.3 : Submission of Clinical Research to OGC
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20.08.3 : Study Start-Up
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Chapter 3 : Study Conduct
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Section 3 : Study Conduct
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30.01.2 : Advertising for Clinical Trials
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30.02.2 : Clinical Trial Subject Recruitment/Screening
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30.03.3 : Obtaining Informed Consent
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30.04.3 : Obtaining Informed Consent From Subjects Who Do Not Speak/Read English
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30.05.2 : Specimen Collection, Processing and Shipment
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30.06.1 : Data Collection and Case Report Form (CRF) Completion
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30.07.2 : Data Clarification/Query Resolution
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30.08.1 : Investigational Drug Accountability, Storage, Dispensing and Return
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30.09.1 : Sponsor/CRO Monitoring Visit
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30.10.3 : Submission of Protocol Submission of Protocol Amendments to the Institutional Review Board-Health Sciences Research (IRB-HSR)
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30.11.3 : Submission of Serious Adverse Events to the Institutional Review Board-Health Sciences Research (IRB-HSR)
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30.12.3 : Requesting Study Continuation from the Institutional Review Board-Health Sciences Research (IRB-HSR)
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30.13.3 : Adverse Event Monitoring, Assessment, Recording and Reporting
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30.14.2 : Subject Management
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Clinical Trial Billing
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Chapter 4 : Study Closure
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Chapter 5 : Quality Assurance
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Chapter 6 : Post-Approval Monitoring
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