This course will present the conceptual underpinnings of treatment effect estimation under random assignment and complement those underpinnings with a discussion of frequently encountered challenges in the context of social experimentation. Design, sampling, and analysis issues under random assignment will be addressed followed by a brief introduction to propensity score methods as a quasi-experimental option when random assignment is not feasible.

The event will be led by Kirsten Kainz, PhD. Much of Kainz’s work focuses on identifying impacts of education interventions as well as understanding the systemic nature of intervention in education and human services.

Presenter
Kirsten Kainz, PhD, Research Fellow
Frank Porter Graham Child Development Institute

Register

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are ongoing and will alternate week by week. Session A is recommended before attending Session B

Session A is for those who want to learn about N3C, as well as how to engage with project teams and access the data.

Topics include:

• Provide a general overview of N3C, including goals, organization, and community resources such as Domain Teams and Data Liaisons.
• Introduces the 3 data tiers available and important considerations for research driven by the data harmonization process.
• Discusses resources for training and help, as well as the Data Use Request (DUR) process required for researcher access.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

The REDCap Forms Training Session will teach users to build forms using the online designer or data dictionary (lecture/demo).

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Learn more about the quality improvement activities happening at UNC as medical students and faculty mentors present their QI projects. Join for the whole symposium, or for a part of the event.

Learn More

Please join the HERO-TOGETHER team for a special HERO Town Hall. Robert Califf, MD will join HERO PIs Adrian Hernandez, MD and Emily O'Brien, PhD for an overview of the HERO program, importance of HERO-TOGETHER for understanding vaccine safety, and to share early findings. This Town Hall is open to anyone affiliated with a healthcare setting.

Learn more about the project or join the HERO registry to participate in the HERO-TOGETHER study at Heroes Research. For questions, please contactThis email address is being protected from spambots. You need JavaScript enabled to view it..

Registration is not required; WebEx information is below. Please mark your calendars.

Call in: 1-650-479-3207

Access Code: 120 884 3641

Password: 1234

Join Meeting

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational New Drugs (INDs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IND Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).

This workshop will:

• Define an investigational drug, including off-label use of FDA approved drugs
• Provide guidance on determining when the IND regulations apply to research studies
• Discuss the preparation and submission of IND applications to FDA
• Review maintenance and safety reporting requirements
• Review case scenarios

Presenters

Rachel Johnson, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine
Katherine Deland, PhD, Regulatory Affairs Scientist, Duke University School of Medicine

Register

NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IDE workshop Mar 12

Are you interested in improving how you communicate your science? Janet Iwasa will present her work on science animation, graphics, and tools in this seminar.

This event is co-sponsored by the UNC Science Policy Advocacy Group and the UNC Science Writing and Communication Club as part of their 2021 Spring Communication Series.

Presenter
Janet Iwasa, PhD, Assistant Professor of Biochemistry
University of Utah

Register

Data and Safety Monitoring Boards for Trials of COVID-19 Treatments and Vaccines: The Challenges

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Susan S. Ellenberg, PhD. Ellenberg is a Professor of Biostatistics, Medical Ethics, and Health Policy at the University of Pennsylvania.

Presenter
Susan S. Ellenberg, PhD, Professor of Biostatistics, Medical Ethics, and Health Policy
University of Pennsylvania

Learn More

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are ongoing and will alternate week by week. Session A is recommended before attending Session B

Session B is for analysts, statisticians, data scientists, or anyone who wants to gain a broader understanding of the tools needed to work with the data.

Topics include:

• Focus on technical aspects of working with data in the secure N3C Enclave, including use of OMOP concept sets and N3C-specific tooling, such as the Concept Set Browser.
• Introduce commonly used analysis tools, such as Contour and Code Workbooks and corresponding workflows for simple analyses.
• Introduce the Enclave Knowledge Store, a mechanism for sharing and using community-developed code and data across projects.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

Charlotte AHEC and the UNC Department of Medicine will present the 45th Annual Internal Medicine Conference on March 10-12, 2021 offered virtually from the William and Ida Friday Center for Continuing Education.

The conference features cutting-edge, evidence-based updates on common medical conditions managed by primary care clinicians, including SARS-CoV-2 updates designed for internists, family physicians, generalists, advanced practice providers and other health care providers working in an adult primary care setting.

Atrium Health designates this Live Webinar Activity for a maximum of 24.5 AMA PRA Category 1 Credit(s)TM.

Register

Charlotte AHEC and the UNC Department of Medicine will present the 45th Annual Internal Medicine Conference on March 10-12, 2021 offered virtually from the William and Ida Friday Center for Continuing Education.

The conference features cutting-edge, evidence-based updates on common medical conditions managed by primary care clinicians, including SARS-CoV-2 updates designed for internists, family physicians, generalists, advanced practice providers and other health care providers working in an adult primary care setting.

Atrium Health designates this Live Webinar Activity for a maximum of 24.5 AMA PRA Category 1 Credit(s)TM.

Register

The REDCap Hands-On Form Building Training Session will teach users to build forms using the online designer or data dictionary. This session will be a click along hands-on/lecture/demo.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

CTSA Visiting Scholar: Using Mixed Methods Multilevel Research to Explore Implementation of "Screen and Treat" for Secondary Prevention of Cervical Cancer in Malawi

Malawi has the highest cervical cancer burden in the world, and this is at least partly attributable to low use of screening services. There are many complex and multi-level factors affecting cervical cancer screening uptake and treatment completion in Malawi.

Join Corrina Moucheraud, ScD, MPH as she will discuss her work that includes qualitative interviews with Malawian women and men, and clinical and implementation data from "screen and treat" programs to highlight new findings about cervical cancer screening and treatment in Malawi.

Presenter:
Corrina Moucheraud, ScD, MPH, CTSA KL2 Scholar
UCLA

Register

Charlotte AHEC and the UNC Department of Medicine will present the 45th Annual Internal Medicine Conference on March 10-12, 2021 offered virtually from the William and Ida Friday Center for Continuing Education.

The conference features cutting-edge, evidence-based updates on common medical conditions managed by primary care clinicians, including SARS-CoV-2 updates designed for internists, family physicians, generalists, advanced practice providers and other health care providers working in an adult primary care setting.

Atrium Health designates this Live Webinar Activity for a maximum of 24.5 AMA PRA Category 1 Credit(s)TM.

Register

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational Device Exemptions (IDEs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IDE Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).

This workshop will:

• Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
• Provide guidance on when the IDE regulations apply and discuss possible exemptions
• Review significant risk and non-significant risk device studies
• Discuss the preparation, submission, and maintenance of IDE applications
• Review case scenarios

Presenters

Alysa Vereen, PharmD, Regulatory Affairs Scientist, Duke University School of Medicine
David Jensen, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine

Register

NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IND workshop Mar 5

The TraCS Professional Development Seminar series is intended for research professionals, graduate students, postdocs and early stage faculty researchers. It covers foundational skills useful for career development in clinical/translational research.

The third module of this series is Mentor-Mentee Training. Developing and strengthening the mentor-mentee relationship is key to the education and training of future generations of research personnel.

Each session of the seminar will meet Fridays at 12:00 pm. This session is titled: Articulating your Mentoring Philosophy.

Presenter
Susan Pusek, DRSc, Director, Education Programs
NC TraCS Institute

Register

Lessons Learned from the Gates MRI Virtual COVID-19 Trial

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Mohamed Bassyouni, PharmD and Jintanat Ananworanich, MD, PhD of the Bill and Melinda Gates Medical Research Institute.

Presenters
Mohamed Bassyouni, PharmD, Product Development Program Leader
Bill and Melinda Gates Medical Research Institute

Learn More

The UNC Be A Maker (BeAM) program continues to enhance the breadth and depth of resources available to researchers.

Join BeAM for a drop-in virtual open house for a tour of the space, an overview of tools and equipment, and breakout Q&A sessions with staff specialists, experts, and advanced BeAM research users. Get a closer look at the metal shop, electronics workstations, and upgraded 3D printer capabilities including the FormLabs Form 3B resin printer, the new Ultimaker S3, PRUSA multimaterial printer, and soon-to-be-added flexible filaments.

The virtual open house will take place on Monday, March 15 at 4 p.m. Join the session via the button below.

BeAM also welcomes your guidance to help direct strategies and resources. By filling out this eight-question survey, you can help makerspace staff understand the research needs for access, equipment, and messaging.

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are ongoing and will alternate week by week. Session A is recommended before attending Session B

Session A is for those who want to learn about N3C, as well as how to engage with project teams and access the data.

Topics include:

• Provide a general overview of N3C, including goals, organization, and community resources such as Domain Teams and Data Liaisons.
• Introduces the 3 data tiers available and important considerations for research driven by the data harmonization process.
• Discusses resources for training and help, as well as the Data Use Request (DUR) process required for researcher access.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

Wisdom in the Room: Engaging Youth as Stakeholders

Tania Connaughton-Espino and Meredith Burns of SHIFT NC will lead a discussion about the development of SHIFT NC’s new Youth Advisory Council, share approaches for involving youth in local health initiatives, and discuss considerations for others looking to engage youth as stakeholders in their work. SHIFT NC is a statewide nonprofit leading North Carolina to improve adolescent and young adult sexual health.

Wisdom in the Room is a conference call series hosted by the Community and Stakeholder Engagement Program at NC TraCS at UNC-Chapel Hill. It provides a forum for information and resource sharing among community partners, research stakeholders, and others interested in community engaged research.

Presenters

Tania Connaughton-Espino, Director of Training & Evaluation
SHIFT NC

Meredith Burns, Youth Engagement Specialist
SHIFT NC

Register

REDCap Functions is advanced training in using functions with your project such as Surveys, Randomization, Calendar/Scheduling, etc.

The session will cover Imports, Reusing Forms, Exports, Surveys, Data Quality Checks, Collecting Data Offline (REDCap Mobile), Subject App (MyCap), Pulling Epic Data, Special layouts (Shazam), Multiple Languages, and more.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced*)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

The Data Manager is responsible for the complete data process: from design, to build, to quality control, to cleaning, and finally to archiving. In smaller research teams, this role may be absent or overlooked due to other pressing tasks, or may be parceled out as extra duties among team members.

TraCS is hosting this training to help research teams develop better data managers. We will review data manager responsibilities and discuss/practice techniques using REDCap.

This course will be held on 3 consecutive days: Wednesday, Mar 17 - Friday, Mar 19 | 12 - 4 p.m. each day.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Do I Need an Umbrella? Lessons on Communicating Scientific Uncertainty from TV Weather Forecasting

Uncertainty is not only a fundamental part of the scientific endeavor, but a topic that can be difficult for non-scientists to understand. This session will focus on how TV meteorologists address this topic on a daily basis as well as other strategies that can assist in the process of communicating science virtually.

Join Duke Science & Society for the March installment of their SciComm Lunch & Learn Series to hear from Sara Kobilka. Sara Kobilka is the owner and principal consultant at Renaissance Woman Consulting. As indicated in the company name, Sara has a wide-ranging background that includes journalism, broadcast meteorology, informal science education, non-profit management, science communication/outreach professional development, facilitating virtual meetings, and teaching group fitness classes to name a few. She’s currently based in New York (state) but has previously lived in Tucson, Arizona, and throughout the Midwest.

Register

This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.

Each session of the orientation will be held on Wednesday afternoons,1:30 to 4:30pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:

• Introduction to Orientation Series (Marie Rape) - 1:30 - 1:45 pm
• Network of Research Professionals (NRP) and Educational Programs for Research Personnel (Emily Olsson) - 1:45 - 2:05 pm
• Running a Clinical Trial from CDA to Study Closure / OCT Services and Resources (Christine Nelson) - 2:05 - 4:00pm
• Post-Session Q&A Discussion 4:00 pm - 4:30 pm

Register

CRO Career Conversations: Clinical Research Associate

Contract research organizations (CRO) operate in many capacities to support the work of healthcare innovators and help move therapies from idea to market. NC Biotech’s CRO Career Conversations speaker series provides an introduction to key roles within the CRO industry and the opportunity to learn about career pathways, day-to-day responsibilities, and more from professionals currently in the field.

The first event in this series highlights the role of Clinical Research Associates (CRAs).

Learn More

CTSA Visiting Scholar — High risk yet often overlooked: Improving opioid safety for complex older adults

The opioid crisis response has largely overlooked multiple patient populations with complex opioid-related vulnerabilities, including older adults with cancer or dementia.

Join Andrew Roberts for a presentation of findings from his KL2-funded work examining high-risk opioid use patterns and outcomes in older adult cancer survivors. He will also discuss future directions for work informing opioid safety interventions for older adults with cancer and dementia.

Presenter:
Andrew Roberts, PharmD, PhD
CTSA KL2 Scholar
University of Kansas Medical Center

Register

The Data Manager is responsible for the complete data process: from design, to build, to quality control, to cleaning, and finally to archiving. In smaller research teams, this role may be absent or overlooked due to other pressing tasks, or may be parceled out as extra duties among team members.

TraCS is hosting this training to help research teams develop better data managers. We will review data manager responsibilities and discuss/practice techniques using REDCap.

This course will be held on 3 consecutive days: Wednesday, Mar 17 - Friday, Mar 19 | 12 - 4 p.m. each day.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Join the NRP and Marie Rape, RN, BSN, Associate Director of the NC TraCS Regulatory Service, for an education session on Data and Safety Monitoring plans.

Attendance at this event is pending approval for 1 contact hour of clinical research education on applications for Maintenance of ACRP's CCRC®, CCRA®, CPI® or ACRP-CP® certification designations

Presenter: Marie Rape, RN, BSN
Associate Director, NC TraCS Regulatory Service

Register

The Data Manager is responsible for the complete data process: from design, to build, to quality control, to cleaning, and finally to archiving. In smaller research teams, this role may be absent or overlooked due to other pressing tasks, or may be parceled out as extra duties among team members.

TraCS is hosting this training to help research teams develop better data managers. We will review data manager responsibilities and discuss/practice techniques using REDCap.

This course will be held on 3 consecutive days: Wednesday, Mar 17 - Friday, Mar 19 | 12 - 4 p.m. each day.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

HERO–Learning Together about Vaccines for SARS-CoV-2

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Emily O’Brien, PhD, FAHA of the Duke Clinical Research Institute and Robert M. Califf, MD, MACC of Verily Life Sciences and Google Health.

Presenters
Emily O’Brien, PhD, FAHA, Associate Professor
Duke Clinical Research Institute, Duke University School of Medicine

Learn More

CCHD Spring Series — Culture & Developmental Science: Considering Context, Culture, and Intersectional Approaches

The Frank Porter Graham Child Development Institute's Carolina Consortium on Human Development is honored to host a panel discussion on Discrimination, Context, and Health.

Panelists: Dr. Mayra Bámaca, Dr. Glorisa Canino, and Dr. Shawn Jones

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are ongoing and will alternate week by week. Session A is recommended before attending Session B

Session B is for analysts, statisticians, data scientists, or anyone who wants to gain a broader understanding of the tools needed to work with the data.

Topics include:

• Focus on technical aspects of working with data in the secure N3C Enclave, including use of OMOP concept sets and N3C-specific tooling, such as the Concept Set Browser.
• Introduce commonly used analysis tools, such as Contour and Code Workbooks and corresponding workflows for simple analyses.
• Introduce the Enclave Knowledge Store, a mechanism for sharing and using community-developed code and data across projects.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.

Each session of the orientation will be held on Wednesday afternoons,1:30 to 4:30pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:

• UNC Institutional Review Board Processes (IRB Analysts / Staff) - 1:30 pm - 3:30 pm
• Conflict of Interest (Joy Bryde) - 3:30 pm - 4:00 pm
• Post-Session Q&A Discussion 4:00 pm - 4:30 pm

Register

The REDCap Open Training Session will review using surveys and provide ample time to answer any questions REDCap users might have.

Our current REDCap trainings are offered as webinar-only.

Register

About REDCap

REDCap is a secure web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research. NC TraCS provides training classes to assist you in getting started with building REDCap data collection forms for your research projects.

Current REDCap training offerings include:

1. Forms (beginner)
2. Forms: Hands On (beginner)
3. Functions (advanced)
4. Open Session (Surveys and general questions)
5. Clinical Data Management (3-day)

For more information, please visit our REDCap webpage.

Join this month's journal club to discuss the use of real world data to evaluate the effectiveness of the BNT162b2 mRNA vaccine as described in this recent paper: BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

Background

As mass vaccination campaigns against coronavirus disease 2019 (COVID-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel's largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine.

Discussion Leaders

Michele Jonsson-Funk, PhD and Sara Dejene

Register

The Path to Preventive Genomics

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Robert C. Green, MD, MPH of Harvard Medical School, Ariadne Labs, and the Broad Institute.

Presenters
Robert C. Green, MD, MPH, Professor of Medicine (Genetics), Harvard Medical School
Director, Genomes2People Research Program and Preventive Genomics Clinic
Mass General Brigham, Ariadne Labs, Broad Institute

Learn More

Join a live training session for the N3C Data Enclave. Users of all types can learn how to navigate the N3C, utilize the Enclave and resources it provides, and learn how to better achieve their analytical goals. This orientation is split into 2 sessions – Session A and Session B. These orientations are ongoing and will alternate week by week. Session A is recommended before attending Session B

Session A is for those who want to learn about N3C, as well as how to engage with project teams and access the data.

Topics include:

• Provide a general overview of N3C, including goals, organization, and community resources such as Domain Teams and Data Liaisons.
• Introduces the 3 data tiers available and important considerations for research driven by the data harmonization process.
• Discusses resources for training and help, as well as the Data Use Request (DUR) process required for researcher access.

Note: This orientation is held alternating Tuesdays | 8-9:30am PT/11am-12:30pm ET

Register

This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.

Each session of the orientation will be held on Wednesday afternoons,1:30 to 4:30pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:

• Good Clinical Practices and Study Documentation (Juanita Cuffee) - 1:30 pm - 2:45pm
• Informed Consent Process (Catherine Barnes) - 2:50 pm - 3:45 pm
• Research Monitor Access (Catherine Barnes) - 3:45 pm - 4:00 pm
• Post-Session Q&A Discussion 4:00 pm - 4:30 pm

Register