ICH GCP and EU Regulations impact on clinical trial monitoring

October 18, 2015

October 2015:  EU standards bodies are so far behind the curve that they now emphasize CSV (which been around since 1995 or so and formally documented in 2005 see Common Format and MIME Type for Comma-Separated Values (CSV) Files) as an indication of increasing computerization of studies:

New emphasis on CSV expectations, as aspects of medical device clinical trials are increasingly computerized….

I will assume that the EU standards bodies on clinical research will consider JSON formats for data interchange somewhere in the next 20 years…

It is unfortunate that clinical trials operations are 30 years behind information technology curve.  The clinical trials industry insists on using goofy/vintage 80s methods for manual monitoring of clinical data and is obsessed with monitoring paper despite logic and empirical data that shows that monitoring of inputs yields 1-2% actionable items related to patient safety and data quality.

Monitoring inputs into a process is a poor way of assuring process quality.   This is why we have SPC – statistical process control and in the data security space, this is why we monitor network events and not the number of spelling errors in Microsoft Word documents stored on a file server.

An excellent review article by Laurie Meehan talks about what GCP changes are being proposed for international clinical research, how and when will they affect you?

Two things:

(1) The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).

(2) At about the same time the guidelines go into effect, new Clinical Trial Regulation (CTR) 563/2014 will replace the current, decade-old EU Directive 2001/20.

Four highlights from ICH E6(R2):

– Guidance on risk-based trial management (including RBM)

– Standards regarding electronic records and essential documents

– Definition of quality management that includes efficient protocol design and collection of essential data

– New emphasis on CSV expectations, as aspects of medical device clinical trials are increasingly computerized

See Big changes

More Articles