EDC or CRO? Perceptions of data control.
When is a CRO not a CRO? A look at 21 CFR Part 312.
“It’s an approved device!” “Our raw data are paper.” Data integrity excuses that get the best of us confused. In the finale of this 2-post series, we cover counters to these common objections plus share a helpful MHRA resource.
“Where is THAT written?” “It’s an approved device.” “It has a CE mark.” “Our raw data are paper.” Data integrity excuses we’ve all heard before. In this 2-post series, we cover counters to these common objections.
We wanted to capture the wealth of experience we have in GCP Expert Jamie Colgin (or at least a bit of it). So we fired some questions and got some surprising answers.
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! This post explains the top 3 steps to avoid a costly ePRO 483.
Most of us feel comfortable with paper records. We like to think they’re the same as electronic records. But we hear rumblings from GMP inspections that FDA doesn’t always share that view. Let’s explore a simplified, hypothetical example to help you understand the importance of “content” and “meaning” and avoid an unnecessary 483.
“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”
“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?