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HCP517Communication And Reporting Mechanisms In Compliance WEEK5: Convincing Executive Leadership

HCP517Communication And Reporting Mechanisms In Compliance WEEK5: Convincing Executive Leadership

 

Imagine you are a compliance officer in a research organization that has been contracted to test a new vaccine for the Zika virus. The organization has been under increased public, corporate, political, and financial pressure to determine whether the new vaccine is a solution to the international public health emergency. To be the first organization to declare the vaccine viable, your organization has side-stepped compliance protocols by skipping straight to human trials. 

Your executive leadership has been reluctant to adopt organizational practices that you believe would satisfy compliance standards and reduce risk. 

Create a 10- to 15-minute, 9- to 12-slide voice-over presentation using either Microsoft® PowerPoint® or websites such as Google Slides™, Adobe® Slate, or Prezi®. 

Include at least 1 slide on each of the following: 

  • Conflicts of interest.
  • Cost allocation and reporting expectations.
  • What research regulations may have been violated?
  • What the reporting protocols to the government may look like.
  • The consequences of clinical research misconduct.
  • The steps you will take to investigate the situation.
  • Your recommendation of an organizational policy to minimize risk until the investigation can occur.

Persuade the executive leadership that you are a knowledgeable compliance officer, that this is the correct course of action, and that they should adopt your recommendations. 

Cite 3 reputable references to support your assignment (e.g., trade or industry publications, government or agency websites, scholarly works, or other sources of similar quality). 

Format your citations according to APA guidelines.