PREP: Professional Research Education Program

Ensuring Patient Safety and Ethics in the Trenches (2018)
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 (2018)
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? (2018)
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 (2018)
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 (2018)
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.

Developing Standard Operation Procedures (SOPs) (2018)
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.

Research Recruitment Methods and Regulatory Considerations Across Study Populations (2018)
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 (2018)
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 (2018)
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 (2018)
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 (2019)
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 (2019)
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 (2019)
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 (2019)
This presentation provided a high level overview of the process and steps for IND and IDE submissions.

Working with Minors in Research (2019)
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? (2019)
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 (2019)
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 (2019)
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 (2019)
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 (2019)
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 (2019)
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 (2020)
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 (2020)
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 (2020) (password Prep2020)
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 (2020) (password Prep2020)
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.

Research During COVID-19 (2020) (password is Prep2020)
During this course you will hear from representatives from the UWCCC Clinical Research Central Office (CRCO); Environment, Health, & Safety (EHS); and HS IRBs office about conducting research during the COVID-19 pandemic. Topics include tips for conducting remote consent and virtual study visits, what needs to be reported to the IRB, and safety best practices for in-person research.

An Introduction to StudyFinder; A New Recruitment Tool to Enhance Enrollment for Clinical Trials (2020) (password is Prep2020)
In this class, the presenters introduce the new online public study portal, StudyFinder.  They provide a broad overview of StudyFinder and what type of studies will be posted. In addition, they cover the requirements for posting and how it could help with study recruitment. Also, they demonstrate the steps involved in preparing protocols to post in StudyFinder.

Best Practices for Multisite Study Coordination (2020) (password is Prep2020)
During this course, participants will hear tips and lessons learned for initiating and navigating multisite clinical research. The presenters will discuss real-life examples as well as common pitfalls and how to avoid them.

Remote Consent 101 (2021) (password is Prep2021)
This presentation describes various options for obtaining remote consent, including how to set up and use DocuSign. Attendees hear a study coordinator's perspective on obtaining remote consent and learn more about regulatory considerations for remote consent.

Clinical Research Data Service - Resources for Counts and Recruitment (2021) (password is Prep2021)
This presentation provides information on clinical data resources available for UW-Madison clinical researchers. These services are typically utilized by SMPH, but some tools are available to other units conducting clinical research. This course includes information on resources for doing patient counts, using the EHR to target participants for recruitment, requesting retrospective clinical data for research and details on how to access the services

Engaging with LGBTQ+ Populations in Research (2021) (password is Prep2021)
This session focused on information researchers should know when engaging with LGBTQ+ study participants, including language and terms to use in research for LGBTQ+ people, survey and qualitative instrument design, with special attention to how to ask about gender and sexual orientation in demographic sections, and how to include stakeholders and use language to recruit LGBTQ+ participants.

Onboarding and Turnover (2021) (password is Prep2021)
In this course, the presenters shared best practices for onboarding and turnover in study teams. They shared tips and tools for keeping organized during staffing changes, providing efficient and comprehensive training to new study team members, and making smooth transitions.

Data Sharing Agreements (2021) (password is Prep2021)
This course provides an introduction to data sharing agreements. The presenters explain when data sharing agreements are needed and why they are important. They also describe the types of agreements, templates, and language that may be used, as well as the general process for obtaining an agreement.

Disability, Inclusion, and Accessibility for Researchers (2022)
This course provides a basis for researchers to consider how they can make research participation more accessible to individuals with disabilities. Specifically, this course provides a general overview of disability, disability rights and laws, and touches on disability as a form of diversity, equity, and inclusion. Privilege and ableism are reviewed and information on accessibility resources are provided.

Introduction to Survey Best Practices (2022)
This course serves as a brief introduction to best practices in designing questions and questionnaires for surveys. Some basic tips and resources for developing and administering questionnaires are shared. Some common pitfalls (and how to avoid them) and frequently asked questions are also addressed.

Recruitment in HealthLink: Self-Service Tools to Identify Potential Research Participants (2020)
This presentation introduces the self-service reporting workbench reports in Health Link and provides links to additional resources. For demos, check out  How to Build Recruitment Report for Hospitalized Patients (Inpatients) and How to Build a Recruitment Report for Patients Undergoing a Procedure/Operation.

Consent Documentation in Health Link
This brief video explains when consent needs to be documented in Health Link and how it should be documented. Guidance, policy, resources, and tips are covered.

Self-Audit Workshop: Subject Charts/Records (2018) (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 (2018) (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 Data Collection Tools/Self-Audit (for non-FDA regulated studies) (no video) (2018)
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.

Health Literacy: The 800 Pound Gorilla in Health Research (2021)   (Email prep@research.wisc.edu for slides and see MRCT Center Health Literacy Resources for more information on health literacy.)
This session introduced health literacy challenges patients face in finding, understanding, evaluating, communicating, and using health information. Understanding research protocols and the risks of participating in medical research is vital for patients to make informed health decisions including consent. The session provided universal precautions strategies to reduce confusion and improve participant understanding.

Working with LGBTQ+ Research Participants (Email prep@research.wisc.edu for slides and see lgbt.wisc.edu/pronouns-matter for information on pronoun usage)
This session covered inclusive practices when working with LGBTQ+ research participants. Attendees learned about and practiced best practices in crafting clinical environments, recruiting, and receiving feedback from queer and trans participants across social identities.

Communicating with Empathy (Email prep@research.wisc.edu for slides)
Trying to explain research clearly to a potential participant is a challenge. Trying to explain a study to someone who is scared or upset is even more challenging. Learning how to respond to these emotions in an empathetic way can ultimately help you and the potential participant communicate more clearly. This session introduced two mnemonics to help study teams communicate empathetically with participants. 

Below are resources that address topics that have been requested but have not yet been covered by PREP:

Documentation and record-keeping

ICTR Clinical Research Toolkit

Clinicaltrials.gov

Clinical Trials Registration and Results Reporting Guidance 

Communication, team development, time management, career-development, conflict management

UW-Madison HR Professional Development 

Diversity, Equity, and Inclusion

UW-Madison Inclusion Resources 

Data Storage

UW-Madison Data Storage Finder

HIPAA

Office of Compliance HIPAA homepage

IND/IDE

FDA Regulated Research Oversight Program

IRB operations; completing IRB applications

IRB Educational Outreach

HRPP Toolkit

• Investigator Manual
• Reliance Manual