Most clinical research studies require the research participant to undergo all research procedures and data collection at an SEC Clinical Research site. Those research procedures and tasks not performed at SEC Clinical Research are typically performed by the research subject at home, such as recording symptoms in a diary, and taking study medications at specific times. Research participants are not charged for any research visits, and their insurance companies are not billed for any clinical research procedures. In general, research participants are paid a modest stipend or fee for attending each research visit. At SEC Clinical Research, we often will pay an additional mileage fee for individuals traveling long distances.
Once a research volunteer signs the Informed Consent Form and enters the study, he/she will be assigned a subject number for privacy protection, and begins with “screening visits” that determine if the research participant meets all of the inclusion and exclusion criteria (refer to The Rules) required for continued participation. Typically, these visits include some basic blood laboratory studies, electrocardiogram, among other simple tests depending on the specific clinical protocol. Sometimes research participants are provided with electronic diaries or other items to be used between research visits to insure that the volunteer can reliably record required information. It is common for research volunteers to begin the screening visits and then be excluded from further participation because of a result obtained during the screening visit process, and this can be frustrating.
If the research participant meets all of the research protocol requirements after the screening visits, he/she will proceed to the randomization visit.