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Rapid Fire: 8 Hot Topics in Research

This one-hour session will consist of eight, 5-minute presentations, on hot topics in the clinical research industry. The sessions will be designed to differentiate between myth and fact, guidance on hot topics and fun inspirational stories.

• Good Cleaning Practices: A Dishwasher's Allegory to Quality in Research presented by David Vulcano

This is a humorous allegory to site quality using an allegory we can all relate to, washing dishes. Many aspects of both good site performance and excellent dishwashing are surprisingly similar...as are the headaches.

• Communicate with Savvy presented by Dalfoni Banerjee

It’s widely believed that communication is a key to project success. However, do we consider that even when we are doing a stellar job, if we aren’t communicating with key stakeholders in ways that resonate with them, all our excellent work and successes are almost for naught? We’ll discuss 12 quick tips for communicating with savvy that will bolster project success.

• Knocking Down the Silos presented by Stephanie Abbott

We spend too much time in Clinical Research battling the technology that is supposed to be there to help us. That’s time taken away from caring for the patient. In order for technology to be effective it needs to be designed to transcend the silos, breaking down the barriers that keep Investigators and staff away from doing what they do best, supporting patients on clinical trials. There are a number of technology options available to sites, but few of them seem to understand research workflow and patient interaction from the site perspective. It doesn’t have to be an “either-or”, it can be an “and”. Sites can support their patients and still not be shackled by the technology involved.

• From Project Manager to Project Implementation Specialist presented by Romiya Barry

Implementation science is said to be the future of clinical research. Project managers possess a unique skill set to help shepherd new therapeutics from concept to clinical practice. Implementation Science theories, models, and frameworks can extend the utility of the Project Management Life Cycle Framework in planning, engaging, executing, evaluating, and reflecting on clinical project implementation.

• Sex vs Gender: Demonstrating Respect for Participants Through Inclusive Questioning presented by Katie Dry

In adherence to FDA expectation, the percentage of male and female participants in clinical research trials is reported ubiquitously across publications. Yet male and female outcomes continue to be presented interchangeably under definitively different variables: sex/gender. Since demographic information often involves self-report, exclusive and discriminatory intake forms, even if unintentional, can have significant consequences, not just on data accuracy, but on the patient’s perception of the care in to which he or she is entering. Acknowledging that patient-centered care is an emerging focus of clinical trial professionals, this rapid-fire session will emphasize the key differences between sex and gender and explore, from the patient’s perspective, the immediate need to collect these demographics accurately and inclusively. The session will also highlight how competent introductory interactions with patients have the potential to improve recruitment, safety, retention and outcomes.

• 'Certify'ably Confused: Certifying Source Documentation presented by Gina Remington

FDA's regulations related to investigator record keeping and record retention (21 CFR 312.62) are quite general. Twenty-first century research also imposes a shift from a paper to a paperless system, further contributing to the confusion around the concept of certifiable copies of research records. The ICH guidance related to use of certified copies usually applies to circumstances whereby original records are duplicated to a different form of media for archiving purposes and the originals are destroyed (ICH, 2018). However, if a certified copy substitute for the original is warranted, an SOP to describe how such copies would be made verified and documented is helpful, decreasing time spent by the research coordinator with the CRA during routine monitor visits. This presentation will summarize the current definition of “certified copy” and offer an example of SOP language to address workflow, compliance, and efficiency in research coordination.

• A Father's Inspiration on Public Speaking presented by David Vulcano

This quick session will share a fun story regarding my father's coaching of my speech for an elementary school contest... and how it pivoted my life (and presentations) forever.