Which was subsequently approved by the reb

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Reference no: EM133889046

Case Scenario: You are submitting a new study application to the Research Ethics Board (REB) for a Phase III clinical trial. The study is being conducted in Montreal, with 80% of participants being French-speaking and 20% English-speaking, in a remote area. The sponsor has recommended enrolling a diverse participant population. Upon review, the REB noted that not all elements of Good Clinical Practice (GCP) were included in the informed consent form. Hire Online Assignment help service for completing assignment!

You corrected the error and resubmitted the application, which was subsequently approved by the REB. However, during the informed consent process, the Principal Investigator (PI) noted that a few participants were enrolled based on personal friendships. During a monitoring visit, the sponsor observed discrepancies between the data collected in the Case Report Form (CRF) and the source documents. While passing through the waiting lounge, the sponsor overheard some volunteers discussing their medical conditions and responses to the intervention openly with each other. Additionally, it was found that the PI was not following the study procedures as approved by the REB and detailed in the protocol. Further, there was a delay in reporting a Serious Adverse Event (SAE) to the appropriate regulatory bodies.

Reference no: EM133889046

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