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The addition of a new investigator must be reported to the FDA within 30 days of the investigator being added. The IND may not be shipped to the new investigator until the FDA has been notified.
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
- i. IND - Investigational New Drug
- ii. Expanded Access
- iii. Investigational Use of FDA-approved Drugs or Biologics
- iv. Investigoator-Initiated Research with Drugs or Biologics
- a. Sponsor-Investigator Reporting Requirements
- i. New Protocol 21 CFR 312.30(a)
- x. Drug accountability 21 CFR 312.57a
- ii. Changes in the protocol 21 CFR 312.30(b)
- iii. New investigator 21 CFR 312.30(c)
- iv. Information amendments 21 CFR 312.31
- v. IND safety/adverse events reports 21 CFR 312.32
- vi. Annual reports 21 CFR 312.33
- vii. Withdrawal of an IND 21 CFR 312.38
- viii. Discontinuation of an investigation 21 CFR 312.31(a)2
- ix. Financial disclosure reports 21 CFR 312.57d
- x. Drug accountability 21 CFR 312.57a
- xi. Financial interest 21 CFR 312.57b
- xii. Case Histories 21 CFR 312.62b
- b. General responsibilities of sponsors 21 CFR 312.50
- c. General responsibilities of investigators 21 CFR 312.60
- a. Sponsor-Investigator Reporting Requirements
- v. Emergency Settings: Research in the Emergency Setting (Planned Emergency Research)
- vi. Emergency Use of an Investigational Drug or Device
- vii. Placebo-Controlled Trials
- viii. Washout Issues in Drug Treatment Studies
- E. Physiology intervention studies
- F. Behavioral intervention studies
- G. Diagnostic trial
- H. Investigational Medical Devices
- 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