Develop a Recruitment Plan (Phone Screening - CTU)

Develop a Recruitment Plan

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1. First, consider:a) recruitment feasibility including the prevalence of the study population and b) any needs or challenges specific to the study’s population to plan how to best recruit that demographic.

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2. Outline your recruitment methods. This means you will explain a) how you will identify potential participants and b) how potential participants will find you. Find templated plans in the IRB Submissions Notes Template then navigate to the Template IRB Submissions Notes document..

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3. Outline if and how protected health information (PHI) will be collected and stored as it relates to the specific recruitment methods you previously outlined.

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4. Determine what recruitment resources the sponsor may be providing and what recruitment resources you will make as applicable.

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5. Outline recruitment goals and timelines. Throughout the study you will track recruitment progress and adjust the plan as needed.

a. For example, you may identify potential participants by reviewing KKI’s medical records.

a. For example, the EPIC feasibility reports generated by study staff indicate that 5 potential KKI patients meet the study’s eligibility criteria. To meet the site’s target recruitment number of 10 participants the site will heavily utilize outside alternative recruitment methods designed to attract this study’s target population of young adults.

b. For example, research has shown that studies recruiting young adults yield significantly more interested participants through social media ads compared to mailing physical ads.

a. Some recruitment methods require protected health information (PHI) to be collected. You must specify in the recruitment plan and a document called the HIPAA-4 form how and why you will collect and use this information. You will read more about this later in the module.

b. For example, potential participants may learn about the study through flyers posted around the community and may contact the study staff using the information on the flyer.

You will read more about developing recruitment materials in the next section.

For example, study staff will post flyers throughout the community and will track the specific locations of recruitment materials in a separate study document for the purposes of periodically restocking, replacing old versions with new IRB approved versions as applicable, and to ensure the removal of recruitment materials when the study is closed to enrollment.