3.3.3 Management of research materials and reagents
A. Background & Definitions
This item refers to one of the Core Requirements (Core Requirement 13 - "Adequate handling and storage of samples and materials must be ensured") and is, therefore, considered as essential.
Research materials and reagents, both chemical and biological, including solutions, reagents, samples and other experimental materials should be fit for purpose. All of these items that enable reconstruction of the study should be properly documented and securely stored. This also applies to samples that can be categorized as the output of an experiment (for example, collected tissue that is mounted on histology slides) - in addition to samples, that enter an experiment as input and are the subject of testing.
Corresponding documentation should be sufficient to ensure that work could be repeated in the future using equivalent materials and reagents.
B. Guidance & Expectations
- Research materials and reagents should be labelled (clearly, accurately, uniquely and durably) to indicate identity, concentration, expiry date and storage conditions as appropriate
- The storage and handling of research materials and reagents must be appropriate to their nature. If the storage conditions are critical, they must be monitored and recorded.
Extra care has to be taken:
- For key research materials and reagents (e.g. a chemical compound that is the subject of a study):
- the preparation date and stability data should be available.
- records for the different stages of the reagent's lifecycle should be readily tracked and maintained (including transport, storage, analysis or use and disposal).
- Key research materials and reagents should be traceable to the technician, scientist or company that produced them.
PLEASE DO NOT FORGET
- Provide training on this subject for new employees and refresher training (if appropriate)
- Disposal should be consistent with defined regulation or guidance.
- Often a clear justification when to dispose materials cannot be made for self-prepared reagents. Use a routine that is scientifically sound, that can be tested and can be applied consistently, such as
- defined period (e.g., good for 7 days)
- visual inspection in regular intervals (e.g, look for suspended particles)
- defined opening of a container (e.g., dispose after the tenth opening)
RISK ASSESSMENT Lack of responsibility and ownership for shared research materials and reagents bears a special risk and needs additional attention.
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