Dear Michiko,
oooppppssssss my bad!
I meant to type GxP where x is replaced with M, C or L. And there is GMP, GCP, and GLP (good manufacturing practice, Good clinical practice and Good Laboratory practice). Best never to let Colette, my fiancee, know I made that mistake!! .:) She works on the Quality side of pharma (called "compliance" and aka "QA/QC", for quality assurance quality control), concerned with auditing the GxP processes and procedures. And yes, there are occasional situations where a specific QA/QC type regulatory requirements in say Europe differs in important ways from the US, etc. Another major aspect of regulatory criteria is the existence of an "audit trail". Likely nearly every employee in pharma has heard the adage or a variation on "if it isn't written down it doesn't exist". Pharma can and many times is audited by a regulatory authority, by "announced" or "unannounced" audit inspections. As to databases,vs data sets and assuming your project is in pharma, there may be several databases, and some data, such as adverse events are in the both the clinical trial database (often ORACLE) and the regulatory or pharmacovigilance database(s) because of requirements to report "serious" (vs. severe) to appropriate regulatory authorities in an expedited manner. With few exceptions, nearly every process or procedure in pharma is governed by SOP's (standard operating procedures) and the SOP's library and records of SOP training may be administered by the QA/QC function. Typically anyone starting a new job in pharma, will train on the SOP"s applicable to their role in the first week or so of the new job. and in the Biostatistics world there may be a dozen possibly more SOPs. And a few of those SOPs are "cross training" from, say, Clinical or data management. And employees including contractors and consultants and vendors such as "FSP" (functional service provider) CRO's are required to re-read sponsor SOP's on say an annual basis or whenever this is a substantial change to an SOP. in your setting governance may be another name for the QA/QC function in pharma. This slide set (with annoying pop-ups) gives a nice explanation of QA/QC
https://www.slideshare.net/garginanda93/basic-concepts-of-qa-and-qc------------------------------
Chris Barker, Ph.D.
2022 Statistical Consulting Section
Chair-elect
Consultant and
Adjunct Associate Professor of Biostatistics
www.barkerstats.com---
"In composition you have all the time you want to decide what to say in 15 seconds, in improvisation you have 15 seconds."
-Steve Lacy
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