Tuesday, August 14, 2007

The Gospel According to AdvantageEDC

AdvantageEDC is the Electronic Data Capture platform that my company has developed to assist in our efforts in support of a variety of medical clinical trials, registries and other studies. I'm part of the core team that developed and maintains our platform. During a recent weekly meeting, we were discussing the protocol monitoring implications of parent/child questions.

Huh, what? Well, protocol monitoring is when someone other than the research site that owns the data goes in and compares data in the AdvantageEDC system with the source documents. Any differences will be noted as discrepant. Parent/child questions would be a set of questions kind of like the following:

  1. Do you smoke? [ ] Yes [ ] No

    • If YES, how many cigarettes per day. _____

No response to the second question is necessary if the first is answered "No." Parent/child questions sometimes cause problems in protocol monitoring if the research site had inaccurately answered the parent question "Yes" and supplied some value for the child question. The protocol monitor would label the parent question discrepant and the child question would also be considered discrepant.

We had considerable discussion on how to resolve the discrepancies from the research site's perspective. Ultimately this led to recognizing that if we fix the parent, then we fix the child.. In other words, when the research site goes back and corrects the parent question to "No," the value of the child question automatically gets blanked out. When the protocol monitor looks at the record again, both discrepancies have been resolved!

God, in all His righteousness, looks at my life like a protocol monitor and sees that it is full of discrepancies where I fall short of His perfect standard. [F]or all have sinned and fall short of the glory of God (Romans 3:23). There are definately discrepancies too numerous to count in my source documentation!

But if we fix the parent, then we fix the child...

Blessed be the God and Father of our Lord Jesus Christ, who has blessed us in Christ with every spiritual blessing in the heavenly places, even as he chose us in him before the foundation of the world, that we should be holy and blameless before him. In love he predestined us for adoption as sons through Jesus Christ, according to the purpose of his will, to the praise of his glorious grace, with which he has blessed us in the Beloved. In him we have redemption through his blood, the forgiveness of our trespasses, according to the riches of his grace, which he lavished upon us, in all wisdom and insight (Ephesians 1:3-8)

God, our Heavenly Father, adopted us into His family, making us His children. Through Jesus Christ, we have redemption and forgiveness so that we should be holy and blameless. Jesus used HIS source documentation (His sinless life) as a substitute for ours so that God, the protocol monitor, looks at us and sees NO DISCREPANCIES!

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