Study dossier
The study file (including the work protocol) is kept close to the animals concerned during the performance of the animal experiment, so that it is available to employees of the laboratory animal location, researchers, IvD employees, NVWA inspectors and ISO / AAALAC auditors, etc. Researchers and laboratory animal site staff who are active in the study concerned must keep their actions, welfare observations and correspondence in one study file. They use the relevant forms jointly. A study file contains the following components:
In this article
Work protocol
The work protocol describes the execution of an animal experiment and everything related to it. This includes contact details of the persons involved, description of research and statistics, the numbers of animals and housing. But also the planning of experimental actions, pain relief, welfare control and humane endpoint.
The Responsible Implementer (VU) is the researcher who sets up and carries out the animal experiment, starting with describing it in the work protocol. This can be the Responsible Researcher (VO) specified in the project licence or another researcher involved in the project (for example a PhD student). The VU must always have authority according to art. 9.
The work protocol is also used when activities are carried out with animals but by law it is not an animal experiment. For example, health monitoring or activities with animals in the context of education that are 'below the threshold '. Those protocols are also reviewed by the IvD.
You can read how to have a work protocol assessed in the infographic “route for submitting a work protocol”
List of actions (realization list)
The actual recording of the execution of experimental actions (other than the aforementioned welfare diary) is done in the action list. A strict chronological order (time axis) of actions to be performed per group must be described in the action list, in order to enable supervisors (e.g. the NVWA, the IvD) to easily verify whether pre-planned experimental actions are in line with the schedule in the WP and at what stage of the experiment the animals are currently.
For this purpose, the IvD has made 2 different action lists that can be adjusted as desired so that it works best for your specific study. These action lists for groups of animals or for individual animals can be found in the list of forms.
Study adjustments
During the course of a study, it may happen that an adjustment has to be made. This could be because there is a change of employees, you need extra animals, add an extra action or because the schedule changes.
Adjustments are assessed by the IvD and if necessary reported to the CCD or submitted as an amendment to the CCD. In that case, after consultation with the DEC, the CCD will decide whether or not to change the licence. In all cases, the approved changes must be added to the study file with a chronological overview of all changes. In the event of a large number or far-reaching changes, the IvD may request an amended WP or list of actions.
Well-being diary
The welfare diary records which clinical signs in animals have been observed in the experiment and which measures have been taken to prevent unnecessary distress. The clinical symptoms and discomfort you can expect, how often you should assess the welfare of the animals and the point when you should remove an animal from the experiment (humane endpoint) are laid down in the work protocol.
Report unexpected discomfort
Sometimes it can happen that unexpected discomfort arises in the laboratory animals that you as a researcher have not foreseen. This can vary from minor discomfort, such as a small wound, to serious discomfort, such as a large tumor or a wound infection.
It is important that the observation of unexpected discomfort in laboratory animals and the subsequent communication and actions of all those involved are properly recorded in the study file. The Central Laboratory Animal Research Facility (GDL) and the UMC Utrecht Brain Center do this with a specially established procedure for reporting unexpected discomfort.
Individual housing
Animal species that naturally live solitary, such as hamsters, are housed solitary. The other experimental animal species are in principle housed in groups within all laboratory animal facilities at Utrecht Science Park (USP). In addition, there may be a variety of reasons, such as biological, welfare, experimental or practical reasons, which make it desirable or even necessary for animals to be individually housed temporarily or permanently.
It is therefore possible to (temporarily) house test animals individually. This must be clearly described and substantiated in the study file and must meet the conditions included in our policy.
Checklist for monitoring animal experiments (CMD)
Use the checklist Monitoring Animal Experiments to continue to comply with all rules and requirements. This also helps you monitor animal welfare. Within two weeks of the arrival of the animals, have a colleague (researcher, animal caretaker, research analyst or biotechnician) complete the checklist and keep it in the study file. By subsequently carrying out this checklist every quarter, your file remains up-to-date and you are always prepared for an audit.
Other correspondence and attachments
Make sure that your study file remains as complete as possible. Do this by adding all other correspondence about specific instructions and work assignments as well as attachments such as weighing lists to the file. This also applies to datasets that provide insight into the welfare of animals. These are often scores that represent the symptoms of a clinical picture to be modeled, such as, for example, arthritis score, tumor size or neurological deficiency. In this way, all those involved have access to the correct information and have a good insight into the course of the experiment to which animals have been exposed.