Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases

Review elements to include in a basic training program for study personnel Identify methods that can be used for the training Explore how to evaluate effectiveness of training

What the trainee must learn Regulatory requirements Study requirements Institutional, organizational and unit level SOPs External requirements (e.g., multiple study sites) What the trainee should possess Clinical knowledge relevant to the study Organizational skills and attention to detail Ethical principles Ability to work as a team member Self-direction and self-motivation

Modular approach Basic knowledge concerning clinical research Activities to occur before the study begins Activities to occur during the study Activities to occur at the end of, and following, the study Review of performance following an individual study Annual performance from an employee perspective

Grant submitted regarding a study of pneumonia. The study will involve an evaluate of patient response to standard of care treatment. Clinical specimen will be collected. Training: Basic trainings (CITI, HIPAA) Protocol submission IRB review Finances Research at multiple facilities

Grant submitted regarding a study of pneumonia. The study will involve an evaluate of patient response to standard of care treatment. Clinical specimen will be collected. Training: SOPs Standard of care v. intervention Collection of specimen Communication Elements of the consent form and process Finances and billing

Grant submitted regarding a study of pneumonia. The study will involve an evaluate of patient response to standard of care treatment. Clinical specimen will be collected. Training: Informed consent Adverse and serious adverse events Data collection quality audits Monitor visits Documentation Finances

Grant submitted regarding a study of pneumonia. The study will involve an evaluate of patient response to standard of care treatment. Clinical specimen will be collected. Training: Study documents Closeout visit Final study reports

Review elements to include in a basic training program for study personnel Identify methods that can be used for the training Explore how to evaluate effectiveness of training

Paper-based v. electronic documents Individual training responsibilities Group training Case scenarios Checklists Regular group discussions Real-time communication with ability to address questions

Train to the work that is expected to be performed Train to the skill and expertise of the worker Use instructional techniques likely to appeal to the worker and their experiences Evaluate training methods from the trainee perspective Evaluate outcomes of training from the performance perspective

Review elements to include in a basic training program for study personnel Identify methods that can be used for the training Explore how to evaluate effectiveness of training

Evaluate effectiveness of SOPs, ability of staff to adhere to them, ability to staff to perform job functions Limit reliance on question and answer as means of evaluation Focus on objective measures such as observation of activities and documentation Identify key partners and solicit feedback regarding performance Use findings to re-evaluate training program for continuous improvement