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 | |