A study comprises the following structures:
- Purpose (General section)
- The protocol under which the study is to be approved
- Objectives
- Hypothesis
- Rationale
- Start and end date
- Phases
- First define your experimental “phasing”, such as pre-acclimation, study execution / observation and post study analysis.
- First define your experimental “phasing”, such as pre-acclimation, study execution / observation and post study analysis.
- Experiments
- For each phase, define your experiments or experimental groups.
- Experiments capture the list of procedures, interventions, observations, treatments or measurements you will perform with your animals.
- Test methods
- Test methods are the list of procedures, interventions, observations, treatments or measurements that you will perform with your animals.
- When you select the test methods for your experiment, you can specify the timing and scheduling of the tests: what day, what time, how frequent.
- When you select certain test methods, you can also define “endpoints”. Endpoints are results from observations or measurements that exceed the minimum or maximum permitted value, as agreed with the Ethics committee, and that should result in the animal being culled or removed from study for restorative treatment.
In addition to the structure of the study, you will also need to consider the following aspects for your study, which the system requires:
- Staff and access rights
- Who should be able to view your study information?
- Who should be able to conduct the experiments and input study results?
- How many animals are required to power the study?
- How many animals are required in each experimental group?
Using Studies in your Study system explains how to create studies and offers some hints and tips on how to apply common best practices.