PPT-Clinical Trial Data Integrity:

Bi oresearch Mo nitoring Program Jur Strobos MD JD FACEP Olsson Frank Weeda Terman Matz jurstrobosofwlawcom 2404729665 BiMo Investigations Statutory jurisdiction and penalties Regulatory scope of inspection and agency remedies. Dan Fleck. CS 469: Security Engineering. These slides are modified with permission from Bill Young (. Univ. of Texas). Coming up: Meaning of Computer Security. 1. Meaning of Computer . Security. Recall that computer security is described as encompassing at least:. AMWA Northern California Chapter . 04 Oct 2014. 10/4/2014. 1. Topics. Relevant definitions, background. Protocol audiences. Purposes of protocols. Protocol components. Per ICH . E6 . Additional (synopsis, glossary, appendices). Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. Soup to Nuts. Skip Adolph, CPPM, CF. Judy Windle, CPPS. Data Integrity: What does it mean?. Understand Common Pitfalls. Review Deadly Offenders. Understand how to achieve and maintain clean, consistent data. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. Through the Internet and Social Media. Michael DiDiego. Draft Personal Research Opinion Paper . Wilmington University . May 18, 2017. Figure 1 The Dewitt-Clinton, One of the Earliest Railroad Carriages . The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. x0000x0000 x/Attxachexd /xBottxom x/BBoxx 7x2 21x036x 75 x368x04 x/Subxtypex /Foxoterx /Tyxpe /xPagixnatixon 0x/Attxachexd /xBottxom x/BBoxx 7x2 21x036x 75 x368x04 x/Subxtypex /Foxoterx /Tyxpe /xPagix Unblinding. and Termination. Within-trial . decisions . are decisions that need to be made once a . clinical trial.  has already . started, . for example, if there is an . unexpected . problem. . These . “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Collecting data. 2. Data . Statistics is a way of thinking—thinking about ways to . gather. and analyze data.. Trust data. 3. 3. Resource of Data. Experiment/ clinical trial. Survey. http://www.nhs.uk/Conditions/Clinical-trials/Pages/Healthresearch.aspx. Mary Kay Koenig, MD. Associate Vice Chair for Clinical Research. Co-Director for the Tuberous Sclerosis Center of Excellence. Department of Pediatrics. Division of Child & Adolescent Neurology. University of Texas McGovern Medical School. Tony Durkee, PhD. Coordinator for Clinical Trial Reporting. Compliance & Data Office (CDO), Research Support Office (RSO). Karolinska . Institutet. (KI). Email: tony.durkee@ki.se. . 6/17/2021. Tony Durkee. Conducting a Clinical Trial. Wendy M Kohrt, PhD. Nancy Anschutz Chair in Women’s Health Research. Distinguished Professor of Medicine, Division of Geriatric Medicine. University of Colorado – Anschutz Medical Campus.