Clinical Operations-Design to Execution

BayBiotech.NET I nvestigational 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 accountabilit...