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LDSchaffer
@ldschaffer
Eminent Member
Joined: Nov 22, 2023
Last seen: Sep 8, 2025
Topics: 6 / Replies: 6
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Answer to: Comparison of Research Regulations

We do not have anything like this but as I am training a new compliance specialist I realize how helpful this would be.

6 months ago
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RE: Exempt Studies and Closure

@silbertl you do this for exempt studies too? How long do you allow the study team to respond before you close it for good?

2 years ago
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RE: Exempt Studies and Closure

@silbertl you do this for exempt studies too? How long do you allow the study team to respond before you close it for good?

2 years ago
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Views: 307
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Answer to: IRB Volume and Auditing Activity

Our IRB reviewed over 1400 studies in 2023. 200 studies reviewed by external IRB We have a compliance team of 2. In 2023, we had 1 for cause aud…

2 years ago
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Views: 525
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Answer to: Auditing Ceded Studies

We recently audited a study that was ceded to an external IRB due to a complaint our local IRB received. We conducted the audit and reported all the i…

2 years ago
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Replies: 9
Views: 697
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Answer to: Monitoring Frequency

Pre-covid we were auditing investigator initiated studies 5-7 per month. This past year we didn’t get to many of the not for cause audits thanks to m…

2 years ago
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2 years ago
Replies: 0
Views: 487