Table 1.

Common activities of prospective clinical research studies

Activity	Description
Study design/ protocol development	Develop and plan study protocol and activities at various stages of the study
Recruitment	Advertise and invite patients to participate
Screening	Determine participant eligibility according to study inclusion criteria
Informed consent	Educate participants on study risks and benefits, protocol, reporting, and withdrawal, and answer questions and obtain consent for participation; this occurs before participation and throughout the study.
Randomization	Assignment of a participant to intervention or control groups, if applicable
Intervention	Exposure to an intervention (e.g., behavioral, surgical, pharmaceutical) or placebo
Monitoring and assessment	Ongoing monitoring and identification of adverse events via periodic or continuous assessments and participant reporting
Data collection	Any data collected from or about participants at one or multiple time points during the study; varied in nature
Communication	Coordination of resources and services, among research teams, with funding and regulatory entities, and between researchers and participants
Education and training	Training study staff to successfully carry out research protocol; Participant preparation to engage in study processes and relevant procedures, devices, or interventions
Reporting	Documentation and reporting of study progress and outcomes for regulatory compliance, ethical oversight, and funding purposes
Compliance	Meet ethical, legal, and regulatory requirements and guidelines