Because of the need to comply with federal regulations, it can be extremely challenging to develop advertising strategies and subject recruitment materials. Special consideration must also be given to recruitment populations, inclusion and exclusion criteria, and subject compensation.
To prepare for this Application Assignment:
• Review the Lochol Study Synopsis Brochure to further familiarize yourself with the study you will be advertising.
• Review the Learning Resources for the week, including the FDA guidance athttps://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm.
To complete this Application Assignment:
• Write a 1-page advertisement researchers can use to recruit participants for the Lochol drug study from Week 3 of the course.
• Next, write a 1- to 2-paragraph summary of the specific recruitment considerations that guided you in developing the advertisement.
As you work to create the advertisement, be sure to recognize that the final product must be approved by your IRB and meet the regulatory guidelines outlined by the FDA.
Also, as part of Application 4 this week, you will create a mock Advertisement for the Lochol study. Make sure to review the following resource prior to doing so and include it as a resource in your summary (specific recruitment considerations) section:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm
This resource provides many of the guidelines that you need to consider in developing the advertisement.
For Application 4, remember to also include your 1- to 2-paragraph summary of the specific recruitment considerations that guided you in developing the advertisement and use the APA formatted template: include title page, abstract, 1-page advertisement, summary, and reference page. Submit one paper that includes all items.