GLP Animal Study - Change number of treatment sites

JB0424

Starting to get Involved
#1
Hi!

If I run a GLP animal study, and realize after the study starts that I can get more data points per animal than my protocol stated, then is that allowed?

For example, my protocol states that I am going to apply a treatment to 3 different places on an organ. I realize after initiating the study that the organ is large enough to accommodate treatment to 4 places. Within the confines of GLP, am I allowed to collect the 4th data point?

Additionally, do I have to report the data obtained from the 4th point if I do collect it?
 
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shimonv

Trusted Information Resource
#2
Hi,
I am not an expert on animal studies but from past experience, you start off with a small pilot before doing the actual study.
A 'pilot' run allows you to run the protocol and make adjustments (like adding data points), optimize the algorithm, etc.
After the pilot run you do the actual study and analysis.

In your situation you should revise the protocol. As long as you provide a rationale for what you do and no backdating - I don't see a problem with GLP. You have more options than you think!
You can define in the protocol that only in certain conditions data from a forth point will be collected. If you collect data from the forth point you must report it to avoid bias.
Keep in mind that you can use inclusion / exclusion criteria to help you deal with borderline situations.

Goodluck,
Shimon
 
Last edited:

JJ_FDA

Involved In Discussions
#3
In addition to amending the protocol (mandatory) and reporting your additional results (mandatory), don't forget to have the protocol amendment reviewed by your ethics committee (also mandatory)!
 
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