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The sponsor-investigator must report all unanticipated adverse device effects to the FDA and the IRB within 10 working days of receiving the first notice of the event.
Manuals
- UI Investigator's Guide and IRB SOP - DRAFT
- Part 1, Ch. 1 - Intro to the U of I Human Research Protections Program
- Part 1, Ch. 2 - Components of the HRPP (link to flowchart)
- Part 1, Ch. 3 - Other related entities, programs, or committees involved with Human Subjects Research
- Part 1, Ch. 4 - University of Iowa Institutional Review Board (IRB)
- Part 1, Ch. 5 - Use of an External IRB model
- Part 1, Ch. 6 - Foundation of Human Subjects Protection
- Part 1, Ch. 7 - Regulatory Requirements for IRB Review
- Part 1, Ch. 8 - Legal Requirements for IRB Review
- Part 1, Ch. 9 - Institutional Requirements for IRB Review
- Part 1, Ch. 10 - Operations of the UI IRBs
- Part 1, Ch. 11 - Human Subjects Office
- Part 1, Ch. 12 - University of Iowa Projects Involving Human Subjects or Their Data
- Part 1, Ch. 13 - Exempt Human Subjects Research
- Part 1, Ch. 14 - Expedited Review
- Part 1, Ch. 15 - Overall Approval
- Part 1, Ch. 16 - Concept Approval
- Part 1, Ch. 17 - Umbrella Project Approval
- Part 1, Ch. 18 - Full board Review
- Part 1, Ch. 19 - Notification of Approval
- Part 1, Ch. 20 - Documentation of IRB Approval
- Part 1, Ch. 21 - Appeal of IRB Decision
- Part 1, Ch. 22 - Post Approval Survey
- Part 2, Ch. 1 - Human Subjects Research Application Process
- Part 2, Ch. 2 - Hawk IRB Section I. Project Introduction
- Part 2, Ch. 3 - HawkIRB Section II Research Team
- Part 2, Ch. 4 - HawkIRB Section III Funding\Support
- Part 2, Ch. 5 - HawkIRB Section IV Project Type
- Part 2, Ch. 6 - HawkIRB Section V Other HRPP Committee Review
- Part 2, Ch. 7 - HawkIRB Section VI Subject Enrollment
- Part 2, Ch. 8 HawkIRB Section VII. A. Collaborative Research
- Part 2, Ch. 9 - HawkIRB Section VII.B. Study Design
- A. Clinical Trial
- B. Repositories
- C. Registries
- D. Investigational Drugs or Biologics
- E. Physiology intervention studies
- F. Behavioral intervention studies
- G. Diagnostic trial
- H. Investigational Medical Devices
- i. Investigational Device Exemption
- ii. The IRB and the NSR/SR Decision
- iii. Investigator-Intiated Research with Medical Devices
- a. Sponsor-investigators Reporting Requirements
- i. Changes in the protocol 21 CFR 812.35
- ii. IDE safety/adverse device effects 21 CFR 812.150(b)
- iii. Withdrawal of IRB approval 21 CFR 812.150(b)
- iv. Withdrawal of FDA approval 21 CFR 812.150(b)
- v. Current investigator list 21 CFR 812.150(b)
- vi. Annual reports 21 CFR 812.150(b)
- vii. Recall and device disposition 21 CFR 812.150(b)
- viii. Discontinuation of an investigation 21 CFR 812.150(b)
- ix. Informed consent 21 CFR 812.150(b)
- x. Financial disclosure reports 21 CFR 812.43
- xi. Correspondence 21 CFR 812.140
- xii. Financial interest 21 CFR 812.140
- xiii. Device records 21 CFR 812.140
- xiv. Case Histories 21 CFR 812.140
- b. General responsibilities of sponsors 21 CFR 812.40
- c. General responsibilities of investigators 21 CFR 812.100
- a. Sponsor-investigators Reporting Requirements
- Part 2, Ch. 10 - HawkIRB Section VII.C. Genetic Research
- Part 2, Ch. 11 - HawkIRB Section VII.D. Recruitment & Consent process
- Part 2, Ch. 12 - HawkIRB Section VII.E. Study Procedures – What will happen during the course of the study?
- Part 2, Ch. 13 - Section VIII Risks to Subjects
- Part 2, Ch. 14 - Section IX Benefits
- Part 2, Ch. 15 - Section X Privacy & Confidentiality
- Part 2, Ch. 16 - Section XI Data Analysis
- Part 2, Ch. 17 - Section XII Future Research
- Part 2, Ch. 18 - Research related study materials
- Part 2, Ch. 19 - PI Responsibilities after initial IRB approval
- Part 2, Ch. 20 - Continuing Review
- Part 2, Ch. 21 - Reporting Complaints or concerns
- Part 2, Ch. 22 - Project Closure
- Part 2, Ch. 23 - Record Keeping
- Part 2, Ch. 24 - Principal Investigator leaves the University of Iowa