Difference between revisions of "Good Laboratory Practice (GLP)"

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*If a problem is not directly solvable:  
 
*If a problem is not directly solvable:  
 
       A) Sent E-mail alert to other users.
 
       A) Sent E-mail alert to other users.
       B) Report the problem in the issue tracking system (see the [[Issues Tracking]] page or go directly to [https://gitlab.science.ru.nl gitlab.science.ru.nl]).
+
       B) Report the problem in the issue tracking system
 +
*For issue tracking see the [[Issues Tracking]] page or go directly to [https://gitlab.science.ru.nl gitlab.science.ru.nl].

Revision as of 12:36, 22 June 2023


Basic rules

  • No internet on experimental PCs
  • No food or drinks in the labs
  • Make a reservation in Qreserve
  • Use a lab journal
  • Never leave a subject alone
  • There should be at least two people (apart from the subject) present in the lab when an experiment is run off hours †.

† Off hours = outside 9-17 hours or in the weekends

Be a skeptic

Have a healthy skeptical and critical attitude towards everything.

  • Earlier results from the literature and the lab could be messy! Interpretations could be wrong! Experimental designs could be flawed!, etc. etc.
  • Opinions and ideas expressed by your supervisor could be (likely is) wrong!
  • Be skeptical towards your own results. Ask yourself questions like:
     What would I expect? There should be a ‘theory’, ‘model’.
     What do I observe? Plot the data according to the expected theory, or model!
     Do these coincide? If so, does it mean it’s okay? If not: what does it mean? Is there something to worry about?
  • Be skeptical of your own writing and data presentation style:
     Read it out loud and wonder whether someone else would really understand what you’re saying….
     Does the figure really tell what I intend to express? 
  • Last, but not least: never trust the experimental setup at face value!

Control measurements

  • EVERY experimental protocol starts with STANDARDIZED control experiments.
  • If a patient is going to be measured, this control experiment is run with a healthy subject BEFORE the patient is placed in the setup.

Real time data checking

In order to check data real time there should be a pre-cooked analysis and display (plot) that provides ALL the necessary data that are needed for a complete assessment of the data quality. This plot is stored on disk and belongs to the data set of that recording day.

Lab journal

Every experimenter keeps a personal Lab journal.

Obtaining and preparing the lab journal

  • Everybody who is performing any experimental work has to own and use a lab journal.
  • The lab journal can be picked up at the DCN secretariat.
  • The cover of the lab journal has to provide the following information:
     A)The name of the experimenter (names if lab journal is continued by a successor, see below)
     B)The title of the study/project
     C)The starting date and eventually the date of finalization of the journal.

Record keeping: general instructions

  • All pages are numbered before using the lab journal.
  • The first 4 pages will be assigned to create a table of content of the main experiments (with page numbers)
  • The standard language of the lab journal is English.
  • The header of the description of every new experiment shows a title and the date.
  • The respective experimental protocol has to be clearly depicted. If you used paper forms then the form has to be transferred or copied and pasted into the lab journal.
  • Every single step of the experiment has to be described in a way that an external reader can fully reproduce the experiment.
  • If applicable one can refer to the protocols and descriptions of previous experiments in the same lab journal WITH the respective page numbers.
  • When referring to previous descriptions or protocols EVERY single modification or exception has to be noted.
  • When using solutions with lot-numbers (e.g. enzymes, antibodies, specific chemicals etc.) the lot numbers has to be noted in the lab journal.
  • Clearly note how samples are marked and where they are stored.
  • All incidences, perceptions, results and conclusions have to be written down in a clear, transparent and reproducible way.
  • Also experiments that failed or have been aborted need to be noted down, including a clear explanation of what caused the failure of abortion.
  • It is strictly forbidden to remove pages or to take the lab journal home.

Data

  • Write down the name and location of all data files that are connected to a given experiment.

Control system

  • Every month the direct supervisor will check the lab journal.
  • The direct supervisor will place her/his signature underneath the last page that was checked. If needed, shortcomings will be directly discussed with the experimenter.
  • Every 3 months, some lab journals will be checked for compliance with these rules by the technical staff.

Storing the lab journal

  • Finalized lab journals that are not directly relevant for ongoing studies anymore will be delivered to the DCN secretary and centrally archived.
  • At regular intervals but at latest after a experimenter finalized a lab journal, the journal needs to be scanned and electronically stored. One file per lab journal!
  • Lab journals which are not filled after a experimenter has finalized the study can be continued by experimenters working on continuation of the project or a similar study.

Problem solving

Everybody should be aware that complex setups can ALWAYS break down. They break down when you LEAST expect it. You should be prepared to IDENTIFY such problems immediately. You CANNOT assume that if it worked yesterday, it will work today too!

Two short-term actions can be taken to prepare ourselves for this:

  • EVERY experimental protocol starts with STANDARDIZED control experiments. The results of these controls are stored on disk with the actual data sets. These controls even get standardized names, so that they are readily identifiable.
  • Experimental results and stimuli are analyzed and displayed ON THE FLY. Casual checking of signals from the Head Tracking System on the oscilloscope does not count as a real control (although it should be done too….).

Try to tackle the problem scientifically:

  • Is it a technical (instrumentation) problem, or a physiological (subject) problem?
  • If technical: inside the measurement cabin? (magnetic field, coil, speakers, LEDs) or outside (TDT, computer, amplifiers, …)?
  • If you can’t find it (and did some basic tests): no shame, but warn the technicians.
  • If a problem is not directly solvable:
     A) Sent E-mail alert to other users.
     B) Report the problem in the issue tracking system