Article Figures & Data
Figures
- Figure 1.
The planning and study selection process for studies conducted in the AAFP NRN.
Tables
Members of the research team Role/Responsibilities Housed Knowledge and Experience Principal Investigator (PI) Leads the study team. Oversees the development of the protocol and all aspects of the study related science. Ultimately responsible for carrying out the research study. Internal or external Preferably experienced in practice-based research. Knowledgeable in the field of study. Coinvestigator Works with the PI to implement the study Internal or external Has skills and knowledge in a content or research-skills field Project manager Is responsible for ensuring that all details of the study are carried out successfully, in partnership with the PI. Develops and keeps track of the timeline. Oversees the submission of application to the primary IRB. Works with the Research Coordinator to ensure a realistic budget is instituted. Manages all other aspects of the study and AAFP NRN staff. Internal and/or external. For studies in which the PI is external, there may be both an external and internal project manager. Master’s degree preferred. Experience in practice-based research. Consultants Budgeted for a certain period of time to work on specific tasks. External Has a specific skill or knowledge in a subject area that is pertinent to the study. Research assistant Assists the project manager in taking the study to the field. Manages the project data. Internal Bachelor’s or master’s degree. Previous research experience. Senior scientist Represents the interest of the AAFP NRN members and staff and is sensitive to the work burden expected. Internal PhD level. Has knowledge of internal AAFP NRN procedures. Practice lead physician/ clinician Oversees implementation of the study in the practice. External MD, DO, occasionally PhD, PharmD, NP, or PA Practice study coordinator Coordinates the research locally in each participating practice. Generally responsible for data collection. External Office manger, nurse, technician, or practice research coordinator Topic Description Time Alotted in 12-Hour Session Research protocol Brief overview to explain research design and protocol to the practice staff and physicians 1 to 2 hours Pertinent skills Study-specific skills discussed as necessary Varies IRB and HIPAA issues Overview of IRB process, copy and status of AAFP IRB application, HIPAA requirements, and instructions for Human Subjects Training 30 minutes Patient recruitment Inclusion/exclusion criteria and suggested methods of patient recruitment 30 minutes Obtaining consent/authorization Policies regarding proper methods for obtaining patient consent for research and authorization for disclosure of PHI, consent and authorization forms 45 minutes to 1 hour Study implementation Overview of implementation in study, may or may discuss details of implementation (study specific) 3 hours Data collection and case report forms Explanation of and purpose of patient data collection instruments, serious adverse event forms, and data tracking forms as well as instruction on how and when to complete these forms 2 hours Train-the-trainer skills Strategies for training onsite practice staff 30 minutes Sustaining enthusiasm Strategies to sustain momentum and suggestions to prevent problems 30 minutes Questions and feedback Time allotted after each topic for questions or feedback by practice staff and physicians 2 hours Contact information Contact information for members of research team, lead physicians, practice study coordinators, and other pertinent resources
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