BayBiotech.NET Decentralized clinical trials should account for adequate processes for reporting medication errors and safety events...A well-organized plan must include training of participating HCPs on following study protocol processes for the reporting of adverse events. Not only should HCPs be made aware of the contact details of the study personnel, but participants should also be informed so they can reach out for medical assistance. A lot of these responsibilities to prepare the logistical details fall on the study sponsor; however, study Principal Investigators also remain responsible for working with local HCPs to monitor the clinical safety of the participants... Useful link: https://www.fda.gov/media/189263/download?attachment
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...