Table 2.

Elements for Research Study Training Manual

TopicDescriptionTime Alotted in 12-Hour Session
Research protocolBrief overview to explain research design and protocol to the practice staff and physicians1 to 2 hours
Pertinent skillsStudy-specific skills discussed as necessaryVaries
IRB and HIPAA issuesOverview of IRB process, copy and status of AAFP IRB application, HIPAA requirements, and instructions for Human Subjects Training30 minutes
Patient recruitmentInclusion/exclusion criteria and suggested methods of patient recruitment30 minutes
Obtaining consent/authorizationPolicies regarding proper methods for obtaining patient consent for research and authorization for disclosure of PHI, consent and authorization forms45 minutes to 1 hour
Study implementationOverview of implementation in study, may or may discuss details of implementation (study specific)3 hours
Data collection and case report formsExplanation 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 forms2 hours
Train-the-trainer skillsStrategies for training onsite practice staff30 minutes
Sustaining enthusiasmStrategies to sustain momentum and suggestions to prevent problems30 minutes
Questions and feedbackTime allotted after each topic for questions or feedback by practice staff and physicians2 hours
Contact informationContact information for members of research team, lead physicians, practice study coordinators, and other pertinent resources