PREP: Professional Research Education Program

What topics has PREP presented in the past?

Since its start in 2018, PREP has given the following presentations, most of which have been video-recorded and can be viewed on the SMPH Video Library (specific videos linked to below):

Ensuring Patient Safety and Ethics in the Trenches
This session addressed the importance of ethics and patient safety and included a discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more.

Identifying, Documenting, and Reporting (Serious) Adverse Events
This presentation defined adverse events, described the various ways they can be identified and documented, and reviewed reporting requirements. This presentation will also described tips and pointers to avoid common mistakes.

Revised GCP Guidelines: How does it impact me?
This presentation described updates to the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E6 Guideline, referred to as R2. The revisions are intended to modernize and encourage implementation of more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. This presentation reviewed the changes and how they impact the PI and members of the study team.

Developing Data Collection Tools for Investigator-Initiated Clinical Trials
This presentation reviewed how to apply the Quality by Design (QbD) principles when developing data collection tools, including identifying the critical data as well as the most efficient and effective ways to capture and manage the data.

Internal Quality Assurance (QA) Procedures
Representatives from a variety of established clinical research programs and/or departments described the internal quality management practices and procedures they have in place, followed by a panel discussion and question and answer session.

Self-Audit Workshop: Subject Charts/Records (no video)
In this interactive workshop, attendees experienced the record review process from the other side.  Institute for Clinical and Translational Research (ICTR) deconstructed the audit process, shared most common findings and their own tips and tricks for reviewing study records. Attendees then applied these principles as they performed an interactive audit of provided mock study subject charts. Following the mock audit, attendees discussed and evaluated measures to address the findings, in both a reactive and proactive manner.

Self-Audit Workshop: Regulatory Files/Binders (no video)
In this interactive workshop, attendees experienced reviewing regulatory files and records. Institute for Clinical and Translational Research (ICTR) deconstructed the audit process, shared most common findings and their own tips and tricks for reviewing study records. Attendees then applied these principles as they performed an interactive audit of provided mock regulatory files/binder. Following the mock audit, attendees discussed and evaluated measures to address the findings, in both a reactive and proactive manner.

Developing Standard Operation Procedures (SOPs)
Study teams are encouraged to create and maintain SOPs to help prevent non-compliance. This presentation included an overview of the recommended SOPs that each program/department should have, the sections to include when writing SOPs, how to manage SOPs, and how to train study staff on SOPs. Furthermore, the presenters shared some common challenges, lessons learned, and provided example SOP templates.

Developing Data Collection Tools/Self-Audit (for non-FDA regulated studies) (no video)
This presentation was geared toward non-FDA regulated research studies. The presenters described tips and tricks to consider when developing data collection tools, and attendees took part in an interactive workshop in which they learned and applied self-audit principles to mock subject charts and records.

Research Recruitment Methods and Regulatory Considerations Across Study Populations
Representatives from various established clinical research programs and departments discussed various recruitment methods applicable for different subject populations.

How to Write an Informed Consent Form
This presentation reviewed the new Informed Consent Form templates developed by the Health Sciences IRB Office, as well as common errors that can be prevented when writing an informed consent document.

How to Obtain Informed Consent
This presentation reviewed the important, basic concept of the informed consent process. This training was geared towards the newer members of the study team or those that were looking for a refresher.

HIPAA Implications in Research
This presentation reviewed what the Health Insurance Portability and Accountability Act is and how it applies to research at UW-Madison.

How to Manage Conflict
This presentation covered steps to effectively manage conflict and apply those steps to different scenarios that may arise within research study teams.

Research Billing Compliance
This presentation covered the many facets of Research Billing Compliance. Topics included how the OnCore system is used to facilitate research billing and how the UW Health Patient Billing staff receive and use the information. The presenters shared the most common errors and tips and tricks to prevent them.

Privacy, Confidentiality, and HIPAA in Practice
This presentation provided an overview of how privacy, confidentiality, and HIPAA apply to research. It also provided detail on what the IRB is looking for regarding privacy and confidentiality concerns and how identifiability and HIPAA affect research at various stages, including recruitment and data storage.

IND/IDE Preparation, Submission, and Maintenance
This presentation provided a high level overview of the process and steps for IND and IDE submissions.

Working with Minors in Research
This presentation discussed considerations to make when planning research projects that involve children, from regulatory requirements to strategies for effective recruitment, enrollment, and interaction with children and their parents during the research process.

Study Recruitment: What do "real people" recommend? 
Want to create more effective recruitment materials? Interested in learning about recruitment strategies that potential study participants recommend? In this presentation, staff from the Wisconsin Network for Research Support (WINRS) share best practices and actionable advice from 9 years of experience working with community/patient advisory boards.

Study Initiation--Using the Clinical Research Infrastructure and Resources 
This course described tips for effective and efficient study initiation as well as UW resources that are available to assist along the way.

Single IRB Review
This session explored strategies and requirements for studies when UW-Madison is serving as the IRB of Record for external sites. It also covered IRB Review under the revised Common Rule as well as ceding IRB review.

Introduction to the new ClinicalTrials.gov Service Line
UW has introduced a free CT.gov service line to assist study teams with registration, maintenance and result reporting to CT.gov. This presentation covered the history of ClinicalTrials.gov, reasons to register to this public database, the dynamic nature of records, and how the Service Line can be utilized by study teams.

Recruitment: Building Trust Between Minorities and Researchers 
This course introduced the basic concepts in the Building Trust curriculum: Culturally Confident Engagement for Translational Research. Topics included a formative exploration of how past research abuses contribute to a legacy of mistrust today and information on how and why to build community relationships.

Capacity to Consent Considerations in Research 
This course covered regulatory and practical considerations when working with individuals lacking capacity to consent. The presenters also discussed issues such as assessing/recognizing lack of capacity, working with legally authorized representatives, and temporary versus permanent lack of capacity. Throughout the presentation, presenters described best practices and shared real life examples.

Oneida Nation of Wisconsin and the Alzheimer's Disease Research Center: A Model of Engagement That Worked 
In this course, the speaker described how the partnership with the Oneida Nation and the Inclusion of Underrepresented Groups Core (IURG) of the Alzheimer's Disease Research Center (ADRC) came to be. The key steps needed to build the critical relationship and how to be mindful in developing partnerships with tribal nations were also explored.

Introduction to Statistics for Everyday Use in Research 
This course provided general information on “statistics” for everyday use either in the planning of a study or for a manuscript, such as common statistical tests, analysis software, and statistical plans. Topics also included non-statistical factors such as study design, feasibility of recruitment, and sample sizes.

IRB Reportable Events and How to Prevent Them
The password for the recording if pYsqz2aJ. During this course, attendees learned about the categories of Reportable Events and how to determine if an event requires reporting to the IRB. Attendees also learned about ICTR’s Study Monitoring Service and the Post-Approval Monitoring Program, common monitoring findings, and how to prevent findings from occurring.

Changes of Protocol: IRB and Study Team Guidance 
The password for the recording is yN3fg3d4. This course described the Change of Protocol process from both the IRB and study team perspectives. The presenters described when and how changes are submitted, the IRB review and approval process for changes, how to update study-related documents following a change, and how to provide and document training on changes. Best practices and tips are shared throughout.