Today, Whitehall Training has launched a new online GCLP course. The course was written by Louise Handy – Chairperson of the Research Quality Association (formerly BARQA – who published the first GCLP guidance).
The new course is a perfect complement to our existing Good Clinical Practice courses – providing the extra information that laboratories need when working with samples from clinical trials.
ICH GCP rules focus on vital aspects such as patient safety and well-being but just don’t provide the specific detail that clinical labs need. Good Laboratory Practice rules do contain sufficient detail but they usually only cover non-clinical safety testing. As a result, GLP is missing important areas of GCP, such as ethics, consent, confidentiality or patient/subject safety.
These are the key points of GCLP:
- Facilities and equipment – these need to be suitable not only for the type but also the volume of samples expected. Roles need to be clearly defined and there should be water-tight QA processes as well as archiving and reporting procedures. Equipment needs to be fit for purpose and regularly maintained
- Contracts & SOPs – all agreements need to be documented and standard operating procedures written and followed.
- The Analysis Itself – must use established and agreed techniques (unless a new type of analysis is the subject of the trial). The work must be meticulously planned in advance and measures put in place to deal with unexpected findings (especially where they might indicate a risk to the trial participant) and work that is outside the lab’s normal SOPs.
- Security – is vitally important not only to ensure the identity and integrity of the sample but also to protect the identity of the patient.
- Records – are vitally important and good archiving procedures are essential to protect the source data and enable conclusions to be verified.