Good Laboratory Practice and Good Clinical Practice

1
Good Laboratory Practice and Good Clinical
Practice

• So you want to do research?
• ASNEMGE, Young Investigators Meeting
• Daisy Jonkers

2
Good Clinical Practice

• International guidelines
• FDA (www.fda.gov/oc/gcp/guidance.html)
• Europe (www.efpia.org/6_publ/document/clinical.
  pdf)
• October 1, 2005
• mandatory for all studies with medication
• functional foods will follow
• Course information (NL www.profess.nl)

3
Good Clinical Practice

• Clinical trial
• research study conducted in human participants
  to evaluate the safety and efficacy of a medicine
  expected to improve patients health
• Major aims GCP
• protection trial-subject (rights, safety,
  well-being)
• to obtain reliable results

4
Main focus GCP

• Rights participants (declaration of Helsinki)
• - detailed information
• - written informed consent
• - right to withdraw
• - data confidentiality
• Reported trial data have to be accurate,
  complete and verifiable
• To comply with approved protocol, GCP,
  relevant regulatory authorities

5
Main contents GCP guidelines

• Declaration of Helsinki
• Protocol, randomisation procedures,
  un-blinding
• Standard operating procedures, case report
  form (CRF)
• Main players and their responsibilities, tasks
  and
• requirements (institutional board,
  investigator, sponsor)
• Costs, adequate resources, insurance
• Data handling, data management
• Adverse events
• Monitoring/audits

6
Good Laboratory Practice

• To ensure quality and reliability
• www.oecd.org
• In vitro studies (cell-cultures)
• Analyses of biological samples
• Animal experiments

7

• Determine the outcome parameter!
• Collection of samples
• Choosing and performing the assay
• Communicate with lab BEFORE you start the study

8
Chose an assay

• Best assay to analyse the outcome parameter
• routine or new (literature/experts)
• Perform and validate assay before study
• which samples
• detection-limit
• inter-/intra-test assay
• positive and negative controls
• Protocol / standard operating procedure

9
Collection of samples

• Type of samples
• Analysis on fresh vs. stored samples
• temperature, medium, conditions, time
• Small portions
• Number / code / date
• treat all samples the same way!!
• register all deviations

10
Performing the assay

• Stick to the protocol and work accurate!!!
• Control temperature, humidity, batch of
  chemicals,etc.
• Limit inter-test variation (one run)
• Lab-journal (write down all deviations)

11
General remarks GLP and GCP

• Data should be accurate, reliable and
  verifiable stick to protocol and standard
  operating procedures
• good registration
• Participants rights
• Animal experiments
• law (EU), animal experiment committee
• respect for animals replacement, reduction en
  refinement