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However, when preparing an investigational product (IP) in a drug room or pharmacy, you need to recap the syringe and transport it to the clinic for injection. Tools or special sharp containers to remove the needle and replace with a fresh and already capped needle. The container can be a rigid plastic container (e.g.,
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines.
This data is important for informing the safety of an investigational product and will only be found if we continue to increase the diversity of clinical trials. Institutional Biosafety Committees (IBC) assess the risk of gene therapies to public health or the environment.
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