Communication Plan Worksheet

Communication Plan Worksheet essay assignment

Communication Plan Worksheet essay assignment

Effective communication is paramount to the success of a clinical trial. Lack of communication and uncontrolled communication can not only impact the quality of the study but skew the data collected for proof of safety and efficacy of the investigational product. Communication not only includes that between the sponsor and the site and internal communication at the study site; but also communication with the study subjects and among study subjects. Social media while beneficial in recruiting and education individuals on clinical trials also provides individuals with easy access for communicating with other subjects. A concern among clinical research sites is the growing use of blogs by study subjects. In these blogs subjects discuss their experiences in a clinical trial, compare the product they received with each other (even providing photos), talk about adverse events, and how they are feeling since starting on the trial trying to determine if they received the investigational drug or the control or placebo. Not only can this skew the results it also impact retention as individuals tend to drop out when they believe they did not receive the investigational drug.

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Find attached an article written by the CEO of Baxter International discussing the importance of communication. You may want to research additional articles, theories, and strategies related to business communication as you develop your communication plan.

Your assignment is to create a graphic design/diagram for an effective communication plan (might look similar to an organization chart) for your study site. Communication may go through multiple levels for example a study coordinator reports an SAE to the investigator which is then reported to the sponsor and the IRB by either the investigator or coordinator (depending on how site manages this). Your design must fit on one page and contain the communication channels listed below:

1. Communication channels between site and sponsor and other outside organizations such as IRB and study vendors (roles at sponsor and site for the various types of communication that occur during the conduct of the study). These may be different roles for different types of communication (for example medical questions may be between the Chief Medical Officer at the Sponsor and the Principal Investigator at the site; queries may be communicated between the monitor for the sponsor and the study coordinator for the site, etc.)
2. Communication channels within study staff (for example review of AEs between the study coordinator and the investigator, data entry between coordinator & data entry staff, reporting deviations coordinator to investigator, etc.).
3. Staff Education & Training on company communication plan (procedures and chain of command); using the proper communication channel for situation.