Good Clinical Practice (GCP) for Clinical Laboratories
Content and Objective of the Course
The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. Article 15 of EU Clinical Trials Directive 2001/20/EC provides provision for the inspection of laboratories that perform the analysis or evaluation of samples collected as part of a clinical trial and expects Member States to appoint inspectors to verify compliance with good clinical practice.
The analysis of samples collected from subjects participating in clinical trials forms a key part of the clinical trials process. Sample analysis or evaluation provides important data on a range of endpoints which is used, for example, to assess the pharmacokinetic profile of investigational medicinal products and to monitor their safety and efficacy. Consequently, it is essential that sample analysis or evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported.
This training course is designed to provide guidance to laboratories and other facilities that perform the analysis or evaluation of samples collected as part of a clinical trial.
Instructions for Attendees and General Conditions:
The content of this training was compiled by Dr. Andreas Grund based on his 14 years of experience in clinical trials This content of the training course has been prepared by the GCP-Service team based on many years of practical experience including GCP audits at many clinical laboratories. It should serve as practical guide and clarify ordinary issues and misunderstandings which have been developed during the last years. It has been prepared for clinical lab personnel who are involved in clinical studies. Nowadays it is expected that all staff involved in clinical trials are properly training. This training course delivers the possibility to provide an unlimited number of persons in a time flexible and cost effective way with an excellent training course in a GCP relevant topics laboratory personal should be aware of.
The online training consists of seven modules and each module lasts approx. 60 minutes:
- Introduction: Development of drugs and medical devices
- The declaration of Helsinki and the GCP guidelines
- Study documents, ethics committee and qualification requirements on investigators
- Investigator responsibilities part 1
- Investigator responsibilities part 2/Sponsor responsibilities/Audits
- Good Clinical Laboratory Practice (GCLP)
- EMA Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples, 2011
The modules will be continuously updated and we try to keep it updated to the most current legal regulations and trends (no liability assumed). Each module consists of a video presentation that takes approx. 45 minutes. Afterwards a multiple choice test needs to be passed. The test consists of 15 questions that will be generated randomly from a pool of 40 questions. After each test the attendees will get a new randomized set of 15 questions. 80% of the questions need to be answered correctly to pass the test. 3 test repeats are possible before the attendee needs to register again. The answering of the questions takes approx. 15-20 minutes. The individual modules can only be processed in the order of module 1-7. After completing all modules and tests the attendees can print the training certificate independently. The certificate contains all topics required by the inspectors of the competent authorities to prove the qualification of clinical laboratory staff.
The entire training has to be done within two months. If the period has expired and the eight questionnaires are not answered correctly, the online training has to be restarted.
Costs and Registration:
The fee of the online training is 300 € plus 19% VAT (for non German persons with a VAT ID number no VAT will be charged). 10 € will be donated to UNICEF. In 2010 we donated 3000 Euro. We also like to offer different discounts to our clients.
After registration you will receive the username, password and the invoice. These login data are valid for two months. During this period you can pass the training modules and tests at any time. After two months your login data will expire.
Is your computer ready for our online training? Read the System Requirements.
For more information, please contact us at
onlinetraining@gcp-service.eu
