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Good morning, Thank you all for your active participation in the ACRP Online Community. While the majority of the discussion posts we see provide value to the community and help others in the network get their questions answered, we sometimes find that ...

When the reference range for some variables change, it is important to note the effective date. Typically it only applies to values AFTER a certain date, not retrospectively to older value (unless stated).  This is usually due to a change in methodology ...

The one to ask about advice to handle the situation is the IRB, NOT the CRA.  This is an IRB issue and they should be the one to respond to your question on how to document the deviation. ------------------------------ Michael Hamrell CCRA MORIAH Consultants ...