Technology And Risk Management Process

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Innovation and the “Change” process have gripped the clinical research Industry in the last few years. Evolution in technology and Risk Management processes consequently lead to release of the latest International Council of harmonization (ICH) Good Clinical practice (GCP) E6 R2 step 4 on Nov 30 2016. Other highlights of the Research Industry are revision to the “Common Rule” “to reduce burden, delay and ambiguity for investigators”, the Food and Drug administration (FDA) encouraging Diversity because there is variability of drug response and FDA’s initiatives for paperless trials with the release of multiple guidance documents addressing technology tools including electronic informed consent (FDA, 2017; HHS, 2017 and
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However, at the site Initiation visit for the first site in the study, I encountered that the skin rash assessment work sheets list the visit, so the dilemma was how does BEE remain blinded? I immediately escalated this finding to the study team. Informed the site the concern for data integrity from using the worksheets besides instructed the site not be initiated until the study team’s decision to resolve this issue. The site was requested to isolate the worksheets in the interim. The Principal Investigator (PI) is looped in all the communications with the study team including the corrective action plan to resolve this issue. The central team took account of this finding and immediately revised the skin assessment worksheets in the protocol to remove the specific visit information. They were sent to central IRB for approval. The site was shipped the revised worksheets. Arrangements are made for the site to return the worksheets isolated at site initiation. The study team opened the site to enroll subjects after the verification of the returned worksheets. The PI and the study team are content that the issue was identified and corrected before any subject enrollment through timely and meticulous teamwork.
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