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silbertl
@silbertl
Active Member
Joined: Nov 21, 2023
Last seen: May 24, 2024
Topics: 0 / Replies: 9
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Answer to: Reportable Events for Ceded Studies

Hi Virginia, At Cedars-Sinai we do require dual reporting to the IRB of record and to our local IRB in accordance with our own reporting policy. Thi…

8 months ago
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RE: Tools for Compliance Audit of Clinicaltrials.gov

@cmacpherson Apologies for my extremely delayed response! I had failed to subscribe to this thread and forgot all about it. When we did our internal c…

9 months ago
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RE: Exempt Studies and Closure

Yes we include any studies that are Approved in our system without an expiration date. The first year was a doozy but since then has become more manag…

9 months ago
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RE: Exempt Studies and Closure

@a-baumgartner Been there! We switched to the current off-the-shelf product in 2019. Not sure if we can justify the customization for exempt studies t…

9 months ago
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Answer to: Exempt Studies and Closure

At Cedars-Sinai, we review all studies without a continuing review requirement in our submission system (Huron IRB) on an annual basis. We then survey…

9 months ago
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RE: Exempt Studies and Closure

@a-baumgartner That’s an interesting idea! Does your institution use Huron for IRB submissions?

9 months ago
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RE: Tools for Compliance Audit of Clinicaltrials.gov

@cmacpherson Are you auditing what is already registered by your institution/investigators on Clinicaltrials.gov? Or are you auditing your own institu…

11 months ago
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Answer to: REDCap eConsnet

Hi Mary-Tara- At Cedars-Sinai, we follow the same process you described at BU – a PDF of the IRB stamped consent is uploaded to REDCap and participa…

11 months ago
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RE: Monitoring Frequency

@bethany We conduct routine auditing of 12 studies per year on average. We also conduct at least one limited routine audit of consent forms only, whic…

1 year ago
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