Study dossier
The study dossier (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 procedures, welfare observations and correspondence in one study dossier.
Researchers and laboratory animal facility staff involved in the study in question must keep a record of their actions, welfare observations and correspondence in a single study dossier. They use the relevant forms jointly. A study dossier contains the following components:
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 (pdf).
The actual recording of the execution of experimental actions (other than the aforementioned welfare diary) is done in the procedures list. A strict chronological order (time axis) of procedures to be performed per group must be described in the procedures list, in order to enable supervisors (e.g. the NVWA, the AWB) to easily verify whether pre-planned experimental procedures are in line with the schedule in the WP and at what stage of the experiment the animals currently are.
The procedures list is a customized document. You are free to create a document suitable for your situation. You can make this procedures list for groups or individual animals. The procedures list has to be aligned with all persons involved in the animal experiment (the animal facility and everyone listed in table 4 of the WP).
When drawing up a procedure list, at least the following points should be included:
- WP number;
- Author(s) HL / Responsible researcher;
- Identification of the (group of) animals going through the experiment. (Make sure that the blinding is maintained.);
- Steps from the WP as shown in table 4;
- Sign-off box per step and per moment if a step is repeated.
- Per step the date and initials of the competent performer or supervisor;
- Space for comments (per step or with reference to a step).
For advice on drawing up a procedures list, please contact us.
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 procedure 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 dossier 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 procedures list.
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.
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 tumour 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 dossier. To do so, follow the procedure for reporting unexpected discomfort.
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 dossier and must meet the conditions included in our policy.
Use the checklist Monitoring Animal Experiments (pdf) 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 dossier. By subsequently carrying out this checklist every quarter, your dossier remains up-to-date and you are always prepared for an audit.
Make sure that your study dossier 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, tumour 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.
What are the things you need to be mindful of during the study? The animals and your record-keeping. With clear records, everyone involved can find the information they need.
A properly informed team is essential for high-quality research and education, as well as for optimal care for laboratory animals. Use the checklist Monitoring Animal Experiments (pdf) to continue to comply with all rules and requirements and to monitor animal welfare.
The licence has been issued and the experiment has been designed. Now that you’re conducting it, what do you as a researcher or instructor have to look out for?
- Make sure that the work protocol (+ appendices) is kept close to the animals.
- Go through the work protocol (+ appendices) with the whole team involved.
- Observe and care for the animals according to the work protocol (+ appendices).
- Make sure you perform all the procedures listed in the work protocol. Don't leave anything out.
- In case of unexpected discomfort, take action, after consultation within the team. In complex situations, contact us. Notate everything accurately in the welfare log, inform the team, and make sure the animal and the housing unit are recognizable.
- If an animal reaches a humane endpoint, follow the agreements in the work protocol. In case of doubt, contact us.
- Within two weeks of the animals’ arrival, have a colleague (researcher, animal caretaker, research analyst or animal technician) fill out the checklist monitoring animal experiments (CMD) (Word), or in education, the Checklist monitoring animal experiments for education (Word). Keep the form in the study dossier. In this way you are prepared for an audit at any time.
- Plan in your calendar to repeat this check once every three months.
- Report any change to the licence using the modification form (Word). Follow the correct route (pdf). If there is a hurry, contact us.
- After the experiment, fill out the Welfare evaluation and email it to info.ivd@uu.nl.
Download the practical Key points in animal experiments information card (pdf) which you can add to your dossier or request for a free waterproof print (with holes for a ring binder).
Code of Practice for Monitoring Laboratory Animal Welfare
You are legally and ethically obliged to structure and conduct animal experiments in such a way that the discomfort experienced by the animals is limited as much as possible. To that end, it is vital that you monitor the animal's welfare carefully during the experiment. This will help you quickly notice unexpected discomfort and allow you to take measures to improve the animal's situation.
Agreements regarding the monitoring of animal welfare have been recorded in the Code of Practice for Monitoring Laboratory Animal Welfare. This has been developed by a number of experts involved in animal experiments and published by the NVWA. The code is an application of the legal requirements for dealing with laboratory animals. Following the code carefully will ensure that everyone involved in the organisation, review and conduct of animal experiments possesses the information they need.
Administration in order? Quick check
Is your research administration in order? And can it pass an audit by the Utrecht Animal Welfare Body or the Netherlands Food and Consumer Product Safety Authority (NVWA)? It is easy to check whether your administration is ready for inspection. Do a quick scan. If you answer 'no' to any of the questions below, then you should take immediate action to address the problem. If you would like advice on how to do so, please feel free to contact us.
- Is the humane endpoint properly formulated in the work protocol, and have agreements been made about how to react?
- Are animals with unexpected discomfort and their cages clearly marked?
- Have all 'unexpected discomfort reports' been added to the dossier?
- Has the description of how the unexpected discomfort was dealt with been added to the dossier?
- Are any of the mice/rats over 1 year old? If so, is the necessity of this described in the file?
- Are animals individually housed? If so, is this noted in the dossier, and is the reason for individual housing described?
- Has post-mortem research been conducted on animals that have died unexpectedly, and has a report on this investigation been included in the dossier?
- Have any issues of concern been raised by the Checklist Monitoring Animal Experiments (pdf)? And if so, has the procedure to address them been recorded in the dossier?
Don't hesitate to request for an audit yourself. Please contact us.