Animal Studies: Group-Based vs. Individual Subject Workflows
By Editorial Team on February 16, 2022
Planning an animal study’s workflow is an artform. Regulatory aspects such as GLP and GCP should be considered as well as the observation element (e.g., a single animal or a group) and the data collection flow (e.g., a line of cows or a single puppy at a clinic). Which workflow will boost data integrity and maintain compliance while streamlining animal study operations?
Single Subject – Clinical Setting
GCP studies evaluating therapeutics, nutrition, or quality of life are typically conducted in a clinical environment where a single subject is the observational unit. What animal study workflow platform features or capabilities can be used to facilitate this workflow?
- Align the study schedule and the layout and content of the electronic CRFs with the protocol. This promotes comprehension by site and study personnel and facilitates compliance.
- Use calculations to copy static information from one form to another. This increases data integrity by reducing data entry requirements – and saves time for site personnel.
- When observations can be made by subjects or subject owners, provide them with a mobile app that they can use to directly enter data into the study database. This method reduces transcription errors and promotes contemporaneous data entry.
- Automate as many calculations as possible (e.g., dosing) so that site personnel save time and avoid errors.
- For PK studies, use an animal study workflow platform that natively supports timed observations and sample collection.
Single Subject – Production Setting
Production environments pose their own unique challenges. Often, observations are made at the single subject level – but are done in a multi-subject setting where you never know which cow or pig is going to come through the chute next. In many cases, investigators resort to recording observations on paper – but this can be avoided. How?
- Use an animal study workflow system that integrates with devices such as an RFID wand to quickly identify individual subjects.
- Take advantage of bulk data entry capabilities if those are available. Bulk data entry allows data for multiple subjects to be entered on a single form and then pushed/propagated to the forms and database for the individual subjects.
- This avoids the logistical bottleneck of having to navigate to a different form for each subject.
- For large collections of subjects, make generalized observations about the group (e.g., “they’re all fine”) and then record deviations from this generalization. The two methods above can help with this.
- In some production environments, subjects are in a remote area where an internet connection is not available. Overcome this barrier by using an animal study workflow system that supports offline operation – allowing a mobile device to act as the data source.
Group of Subjects – Production/Facility Settings
For studies involving groups of subjects the observational unit is a collection such as a pen, cage, or tank. In addition to the workflow solutions above, there are some specific flows that are beneficial in these settings.
- Pre-clinical studies benefit from the ability to quickly and easily stand up a new study based on parameters such as the number of animal storage units, the number of animals per storage unit, and the randomization scheme.
- Some animal study workflow systems go beyond structuring data by sites and subjects and allow hierarchies such as facility >barn >subject. This allows for more natural and intuitive data collection.
- Organize forms by room, barn, cage, or tank with a list of subjects in each unit and use the bulk data entry workflow to push data down to individual subjects if needed.
- This allows for group-based data analysis and trending (i.e., calculate food conversion ratios of different feeds per individual storage unit and identify/eliminate the affect of different environments on results).
Prelude EDC supports the animal study workflows described above. Explore how we can optimize your clinical trial workflow.