What laws and regulations must the Reviewing IRB consider?
What constitutes a significant subject complaint that must be reported to the Reviewing IRB?
Who is responsible for addressing a subject's complaint?
If one of the Relying Institutions does not submit the necessary information for continuing review in advance of the expiration date, will all Relying Institutions be affected?
If the Reviewing IRB requests an audit of a study conducted at a Relying Institution, will the Relying Institution receive documentation that the audit was conducted, regardless of the result?
Why does the SMART IRB Agreement require Relying Institutions to report research-related injuries if the events do not also represent unanticipated problems?
Who is informed when the Reviewing IRB makes a determination of serious and/or continuing noncompliance or suspends or terminates a study?
What if an amendment could be affected by state law or other local institutional requirements?
How is it ensured that all study teams are aware of new amendments and know when the Reviewing IRB has approved them?
Does the Relying Institution have a role in the review of amendments (changes of protocol)?

See more

What if a change of protocol only affects one or some of the participating sites?

Permanently deleted user

August 14, 2017 20:45

If the SMART IRB Standard Operating Procedures (SOPs) are used, the Lead Study Team (or the Reviewing IRB, where agreed upon and documented by the Overall PI and Lead Study Team) is responsible for communicating amendments and updated IRB-approved materials to all Relying Institutions. The Relying Institutions must comply with the applicable portions of the IRB-approved protocol and associated study materials.

Comments

0 comments

Article is closed for comments.