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IRB

Getting Started with Huron IRB v10.5 Single-Site Studies (612)


Description
This online course provides a overview of the Huron IRB v10.5 system for single-site studies, including key tasks performed by various users. At the end of this course you will be able to drive the Huron IRB system from end-to-end, from creation of an initial submission through completion of the review process. You will also learn how to complete continuing reviews, modifications, reportable new information, ancillary reviews and external IRB submissions. Note there is a second course that covers single IRB of record functionality for multi-site studies.

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Content
  • Section I. Navigation
  • 1. Navigation
  • 1.1 How to Use this Course
  • 1.2 Introduction to Huron IRB (4:37)
  • 1.3 Navigate the General Dashboard (4:12)
  • 1.4 Navigate the Central Staff Dashboard (6:16)
  • 1.5 Navigate the IRB Page (7:22)
  • 1.6 Navigate the Study Workspace (6:55)
  • 1.7 IRB User Roles and Security (3:08)
  • 1.8 The IRB Workflow (3:31)
  • 1.9 Tips for Completing a SmartForm (6:21)
  • Section II. Initial Submissions
  • 2. Researcher
  • 2.1 Create and Submit a Study (6:05)
  • 2.2 Respond to a Clarification Request (2:54)
  • 2.3 Respond to Modifications Required (2:05)
  • 2.4 Assign Ancillary Reviewers (3:02)
  • 2.5 Submit an Ancillary Review (1:33)
  • 2.6 Complete Exercises 1 & 2
  • 3. IRBC: PRE-REVIEW
  • 3.1 Review a Submission (IRB Coordinator) (2:23)
  • 3.2 Request Clarification (1:44)
  • 3.3 Submit a Pre-Review (2:09)
  • 3.4 The Common Rule (1:29)
  • 3.5 Assign for Further Review (:51)
  • 3.6 Assign the Study to a Committee Meeting (:51)
  • 3.7 Complete Exercises 3 through 8
  • 4. Reviewer
  • 4.1 Review a Submission (Designated Reviewers) (2:08)
  • 4.2 Submit a Designated Review (2:18)
  • 4.3 Complete Exercise 9
  • 4.4 Assign to Committee Review (:48)
  • 4.5 Review a Submission (Committee) (2:38)
  • 4.6 Request a Clarification - Committee Review (2:12)
  • 4.7 Submit a Committee Review (3:41)
  • 4.8 Complete Exercises 10 & 11
  • 5. IRBC: Post Review
  • 5.1 Finalize Documents (1:12)
  • 5.2 Prepare and Send the Determination Letter (1:25)
  • 5.3 Review Modifications Required (3:21)
  • 5.4 Override an Ancillary Review (3:15)
  • 5.5 Complete Exercises 12 & 13
  • Section III. Other Submission Types
  • 6. Continuing Reviews and Modifications
  • 6.1 Create and Submit a Continuing Review (3:44)
  • 6.2 Create and Submit a Modification (3:15)
  • 6.3 Review a Continuing Review or Modification (1:19)
  • 6.4 Common Rule Changes to the Continuing Review Activity (:59)
  • 6.5 Complete Exercises 14, 15, & 16
  • 7. External Review - Single-Site Studies and Multi-Site Studies
  • 7.1 Create and Submit a New Single-Site External Study (3:28)
  • 7.2 Confirm Reliance with an External IRB (1:08)
  • 7.3 Record the sIRB Decision for an External Study (2:13)
  • 7.4 Post Review of a Single-Site External Study (1:45)
  • 7.5 Update Study Details for a Single-Site External Study (3:45)
  • 7.6 Create and Submit a New External Multi-Site Study (3:23)
  • 7.7 External IRB Multi-Site Study Workflow (1:00)
  • 7.8 Update Study Details of a Multi-Site Study Using an External IRB (1:37)
  • 7.9 Create and Submit an External Multi-Site Study Site Modification (2:16)
  • 8. Reportable New Information
  • 8.1 Create and Submit Reportable New Information (2:52)
  • 8.2 RNI Pre-Review (2:56)
  • 8.3 RNI Designated Review (:59)
  • 8.4 RNI Committee Review (1:30)
  • 8.5 RNI Post Review (1:01)
  • 8.6 RNI Action Required (1:59)
  • 8.7 Complete Exercise 17
  • 9. COURSE COMPLETION
  • 9.1 Complete This Course by Uploading Your Submissions
  • 9.2 Huron IRB v10.5 Single-Site Studies Course Survey
Completion rules
  • All units must be completed
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