68 CIRB Website Focus Group Survey - Local Instiutions usab

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1: Background
Q: Tell me your role at your institution, specifically as it relates to IRB.
Q: What involvement, if any, do you have with the submission for IRB approval by the Network Group.
Probe on tracking, status, updates, etc.
Q: Tell me about the specific tasks you do and your interaction with the CIRB.
Note: Make sure the discussion is about their role in the organization and the types of things they need to do
with the CIRB but NOT the procedures they do to get it done.
Probe on the following tasks for the local context:
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Annual Signatory Institution Worksheet about Local Context

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Annual Principle InvestigatorI Worksheet about Local Context

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Initial submission (requirements, timing, feedback, status, etc.)

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Updating/modifying a study

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Updating institution information

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Updating personnel information

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Transferring a study (same form)

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Closing a study

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Other (participant defined) – exceptions (AE, SAE, non-Compliance, planned deviations)

Q: An IRB package goes through multiple stages from the time it’s initially submitted to the time the study closes. Can
you describe in your terms what these stages are (e.g., an initial submission, pending review, initial review, completed
review, etc.)

2: Tools
For each of the tasks, have them demonstrate as needed how they use the CIRB website and IRBManager.
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Q: [For each task mentioned] Walk me through the process of accomplishing [task]. Specifically, what online tools,
websites, or other resources do you use for [task]?
Note: Probe on their understanding of the role of CTSU, the CIRB Website, IRBManager, ePanel, and any other
tools that they need to use (specifically related to working with the CIRB).

3: Training & Support
During the discussion, have them demonstrate as needed how they use the CIRB website and IRBManager for training
and support.
Q: How did you learn the process that you use for these tasks?
Note: Probe specifically on help with the CIRB website and the IRBManager.
Q: What did you have the most difficulty learning, or what do you still need to get help on, in order to acocmplish your
tasks with these tools.
Note: Probe specifically on help with the CIRB website and the IRBManager.

4: Document Types
Q: What’s the difference between the terms quickguide, FAQ, checklist, and manual? Which do you use, and when?
Q: The website has forms and worksheets. Can you discuss the difference between those?

5: Website Content Review
Q: Here’s a list of types of information. Tell me about your need (or lack thereof) for this information. For each item
identified as important, is this currently available, and if so, where?
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History of the CIRB and how it operates (including SOP)

•

How to become a signatory institution

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List of signatory institutions

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Information about component and affiliate institutions and their use of the CIRB

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List of CIRBs and their roles and responsibilities

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List of individual CIRB Members

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CIRB meeting dates and agendas

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List of studies currently under review

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Training material, FAQs, etc.

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Contact information for the CIRB

6: Related Sites
Q: Sometimes websites have links to other related sites or resources. Does the CIRB website need this, and if so, what
links should be included?
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Follow-up: After discussing this, show them the “Related Links” page and discuss which links are useful, if any.

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