238737 Assessing study feasibility and bringing a scientific protocol to life Part 1

Sunday, October 30, 2011: 8:15 AM

Christina Makarushka, MPH , Social & Scientific Systems, Inc., Durham, NC
The purpose of this presentation is to address methods for assessing feasibility and bringing a scientific protocol to life. The value of various approaches for assessing feasibility such as focus groups, pretesting, pilot testing, and staging a run-in will be illustrated. Concepts to consider for bringing a protocol to life will be discussed; practical exercises will be introduced.

Gap Addressed: The need for practical knowledge of how to assess the feasibility and operationalize a scientific protocol in epidemiology and public health research.

Learning Areas:
Public health or related research

Learning Objectives:
Describe approaches to assessing feasibility of a study protocol.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have over 14 years of experience in operationalizing research protocols and implementing epidemiologic studies, including surveys, field studies, and clinical studies. My experience includes the management of medium-size (under 5,000 participants) research studies with responsibilities such as development of protocols, scopes of work, data collection instruments, standard operating procedures, participant materials, recruitment strategies and materials; subcontracting, budgeting, and staffing; training, monitoring and quality control oversight; developing study management systems for tracking study activities; and designing procedures for obtaining informed consent and obtaining IRB approvals. I currently serve as a Study Manager at Social & Scientific Systems, Inc. on the National Institute of Environmental Health Sciences Epidemiology Branch support services contract.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Social & Scientific Systems Epidemiology Employment (includes retainer) and SSS Is an employee owned company

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.