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Investigational Product consideration element in a Decentralized Clinical Trial:
In any traditional clinical study, administration of the investigational product (IP) to the study participants should be performed under the supervision of the investigator or the delegate medical representative.
If a clinical study is considering a decentralized clinical trial model, there are certain factors to be considered for IP administration.
For IP that has a high-risk safety profile, especially in the immediate post administration period, may need on-site dose administration under close supervision of the protocol trained principal investigator. However, for
IP with a defined safety and stability profile and with well-understood low risk characterization may be administered at local health care facilities, mobile research facilities or at study participant's home. Regardless, for an investigational product, a well-established chain of custody and well documented accountability is required to demonstrate a controlled environment. Adequate protocol training would be required for the personnel who will be administering the IP. Overall, although, decentralized clinical trial provides flexibility and reduces patient burden, however, it is the sponsor’s assessment and responsibility to maintain adequate controls over the process to comply with good clinical practices.
Link:https://lnkd.in/eBWNW6f8
decentralizedclinicaltrials, IPaccountability
If a clinical study is considering a decentralized clinical trial model, there are certain factors to be considered for IP administration.
For IP that has a high-risk safety profile, especially in the immediate post administration period, may need on-site dose administration under close supervision of the protocol trained principal investigator. However, for
IP with a defined safety and stability profile and with well-understood low risk characterization may be administered at local health care facilities, mobile research facilities or at study participant's home. Regardless, for an investigational product, a well-established chain of custody and well documented accountability is required to demonstrate a controlled environment. Adequate protocol training would be required for the personnel who will be administering the IP. Overall, although, decentralized clinical trial provides flexibility and reduces patient burden, however, it is the sponsor’s assessment and responsibility to maintain adequate controls over the process to comply with good clinical practices.
Link:https://lnkd.in/eBWNW6f8
decentralizedclinicaltrials, IPaccountability
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