Technology And Risk Management Process

1299 Words6 Pages
Introduction 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 in Nov 2016. Change in the Clinical Research landscape also lead to revisions towards modernization and reinforcement of the “Common Rule” in Jan 2017 besides the Food and Drug administration’s (FDA) ongoing initiatives for paperless trials with the release of multiple guidance documents including electronic informed consent (Federal Register, 2017 and Mitchel & Helfgott, 2017). Other highlights of the Research Industry are FDA propagating…show more content…
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. I informed the site the concern of data integrity from using the worksheets thereby instructing 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) 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 the central IRB for approval. The site was shipped the revised worksheets. Arrangements were made for the site to return the worksheets isolated at site initiation. The study team opened the site to enroll subjects after 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. Innovative Strategy to Collect Good Clinical data Good clinical research data is critical for making thorough
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