SPEAKERS: Janet Vulk, CTO Education Team Trainer & Paige Kular, CTO Education Team Trainer

DESCRIPTION: This session introduces the fundamentals of source documentation in clinical research. Attendees will learn how to define source documentation, identify required source documents, and apply essential good documentation practices to ensure accuracy, compliance, and data integrity.

LEARNING OBJECTIVES: 

• Define source documentation
• Explain essential elements of good documentation practices
• Identify required source documents

Topics we will cover include:

Invoice Processes and Updates: Stay informed about the latest changes and ensure smooth invoicing for your studies.

Navigating Aggie Enterprise (AE) and PPM Billing Events: Gain clarity on billing events, effective use of Aggie Enterprise tools, and the streamlined financial workflows managed by CTMS Ops for consistent and efficient clinical trial operations.

Conversion Revenue: Understand the conversion process and how revenue is tracked.

CGA/ServiceNow Inquiries: Review ServiceNow requests and/or concerns.

Void/Amend Processes: Learn the steps for managing voided or amended transactions in OnCore.

Holding Accounts: Where you can review Holding Account/General Ledger
We are here to answer your questions and provide support. Drop by and let us help streamline your operations!

Researchers increasingly are called upon to address, engage, and partner with diverse publics in the design, implementation, and dissemination of their work. The CTSC’s HERO program is dedicated to helping investigators achieve these objectives. Effective April 5, 2023, HERO will offer complimentary consultations through virtual office hours.

HERO connects researchers and diverse stakeholders, with a focus on patient populations underrepresented in scientific studies, including children, adolescents, and older adults, as well as residents of rural communities and people affected by rare diseases.

• Bring stakeholder perspectives into the development of a research question
• Identify recruitment and retention strategies for adolescent and young adults, older adults, and other special populations
• Identify data collection tools and approaches for hard-to-reach populations
• Develop proposal sections related to stakeholder engagement plans and partnerships
• Effectively disseminate findings to diverse communities
• Make their clinical research more inclusive, relevant, and accessible

Please  schedule an appointment within the  weekly 9 to 10 a.m. office hours on Wednesdays by clicking on this link 

https://CTSC-Office-Hours-Appointments.as.me/HERO

The CTSC Clinical Trial Management System Operations Office offers Florence office hours to provide complimentary assistance with the following:
What is Florence and how it can benefit you
How to get started, training and access
How to request Florence eBinders

The UC Davis Office of Research Institutional Review Board (IRB) offers weekly drop-in office hours consultations.

Get help with the following:

• Does my project require IRB review?
• How do I obtain IRB approval?
• How do I submit a protocol deviation to the IRB?
• How do I obtain ancillary approvals, e.g., IT evaluation, Radiation Use Committee?

Researchers often have questions about statistics in designing a study or analyzing data. Some statistical questions can be easily answered in a short conversation with a knowledgeable statistician. In order to efficiently and effectively meet the statistical needs of clinical and translational investigators at UC Davis, the CTSC - in collaboration with the UC Davis Comprehensive Cancer Center - maintain weekly "office hours" for statistical consultations. These office hours are an opportunity for investigators to consult with a statistician about the design, analysis or presentation of medical research studies in a friendly, informal setting.

Due to the popularity of this program, investigators wanting to attend one of the upcoming office hours are asked to reserve a spot in advance by going to

ctscbiostatisticsworkshop.acuityscheduling.com…

You may make a reservation up to 30 days in advance. In order to be able to adequately address each attendee's question, space is limited to 6. If time permits, we will take questions from attendees without a reservation

The NIH Data Management and Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.

This includes all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements.

Researchers are required to submit a DMS plan as part of their grant application. If you have questions about the new requirement, where to find DMS plan resources or get help reviewing your draft DMS plan. The CTSC has expertise and is offering office hour consultations on these topics.

To schedule an office hours consultation, send an email to cenavarro@ucdavis.edu.

Researchers often have questions about statistics in designing a study or analyzing data. Some statistical questions can be easily answered in a short conversation with a knowledgeable statistician. In order to efficiently and effectively meet the statistical needs of clinical and translational investigators at UC Davis, the CTSC - in collaboration with the UC Davis Comprehensive Cancer Center - maintain weekly "office hours" for statistical consultations. These office hours are an opportunity for investigators to consult with a statistician about the design, analysis or presentation of medical research studies in a friendly, informal setting.

Due to the popularity of this program, investigators wanting to attend one of the upcoming office hours are asked to reserve a spot in advance by going to:

ctscbiostatisticsworkshop.acuityscheduling.com…

Limit of 1 spot per week per project for up to 2 projects.

Researchers increasingly are called upon to address, engage, and partner with diverse publics in the design, implementation, and dissemination of their work. The CTSC’s HERO program is dedicated to helping investigators achieve these objectives. Effective April 5, 2023, HERO will offer complimentary consultations through virtual office hours.

HERO connects researchers and diverse stakeholders, with a focus on patient populations underrepresented in scientific studies, including children, adolescents, and older adults, as well as residents of rural communities and people affected by rare diseases.

• Bring stakeholder perspectives into the development of a research question
• Identify recruitment and retention strategies for adolescent and young adults, older adults, and other special populations
• Identify data collection tools and approaches for hard-to-reach populations
• Develop proposal sections related to stakeholder engagement plans and partnerships
• Effectively disseminate findings to diverse communities
• Make their clinical research more inclusive, relevant, and accessible

Please  schedule an appointment within the  weekly 9 to 10 a.m. office hours on Wednesdays by clicking on this link 

https://CTSC-Office-Hours-Appointments.as.me/HERO

The UC Davis Office of Research Institutional Review Board (IRB) offers weekly drop-in office hours consultations.

Get help with the following:

• Does my project require IRB review?
• How do I obtain IRB approval?
• How do I submit a protocol deviation to the IRB?
• How do I obtain ancillary approvals, e.g., IT evaluation, Radiation Use Committee?

The NIH Data Management and Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.

This includes all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements.

Researchers are required to submit a DMS plan as part of their grant application. If you have questions about the new requirement, where to find DMS plan resources or get help reviewing your draft DMS plan. The CTSC has expertise and is offering office hour consultations on these topics.

To schedule an office hours consultation, send an email to cenavarro@ucdavis.edu.

Researchers often have questions about statistics in designing a study or analyzing data. Some statistical questions can be easily answered in a short conversation with a knowledgeable statistician. In order to efficiently and effectively meet the statistical needs of clinical and translational investigators at UC Davis, the CTSC - in collaboration with the UC Davis Comprehensive Cancer Center - maintain weekly "office hours" for statistical consultations. These office hours are an opportunity for investigators to consult with a statistician about the design, analysis or presentation of medical research studies in a friendly, informal setting.

Due to the popularity of this program, investigators wanting to attend one of the upcoming office hours are asked to reserve a spot in advance by going to:

ctscbiostatisticsworkshop.acuityscheduling.com…

Limit of 1 spot per week per project for up to 2 projects.

This meeting is held once a month to discuss new functionality, ask questions and see demonstrations of Airtable functionality and how it is used here at UC Davis Health. One of our goals is to help cultivate Airtable super-users. All UC Davis Health Airtable users are welcomed (Enterprise, Pro, Free). If you are a UC Davis Health affiliate who is currently on a pro-version or free version of Airtable and would like information on how to upgrade to Airtable Enterprise, we encourage you to join this meeting and reach out to cenavarro@ucdavis.edu.

MS Teams Meeting Link

Topics we will cover include:

Invoice Processes and Updates: Stay informed about the latest changes and ensure smooth invoicing for your studies.

Navigating Aggie Enterprise (AE) and PPM Billing Events: Gain clarity on billing events, effective use of Aggie Enterprise tools, and the streamlined financial workflows managed by CTMS Ops for consistent and efficient clinical trial operations.

Conversion Revenue: Understand the conversion process and how revenue is tracked.

CGA/ServiceNow Inquiries: Review ServiceNow requests and/or concerns.

Void/Amend Processes: Learn the steps for managing voided or amended transactions in OnCore.

Holding Accounts: Where you can review Holding Account/General Ledger
We are here to answer your questions and provide support. Drop by and let us help streamline your operations!

Researchers increasingly are called upon to address, engage, and partner with diverse publics in the design, implementation, and dissemination of their work. The CTSC’s HERO program is dedicated to helping investigators achieve these objectives. Effective April 5, 2023, HERO will offer complimentary consultations through virtual office hours.

HERO connects researchers and diverse stakeholders, with a focus on patient populations underrepresented in scientific studies, including children, adolescents, and older adults, as well as residents of rural communities and people affected by rare diseases.

• Bring stakeholder perspectives into the development of a research question
• Identify recruitment and retention strategies for adolescent and young adults, older adults, and other special populations
• Identify data collection tools and approaches for hard-to-reach populations
• Develop proposal sections related to stakeholder engagement plans and partnerships
• Effectively disseminate findings to diverse communities
• Make their clinical research more inclusive, relevant, and accessible

Please  schedule an appointment within the  weekly 9 to 10 a.m. office hours on Wednesdays by clicking on this link 

https://CTSC-Office-Hours-Appointments.as.me/HERO

The UC Davis Office of Research Institutional Review Board (IRB) offers weekly drop-in office hours consultations.

Get help with the following:

• Does my project require IRB review?
• How do I obtain IRB approval?
• How do I submit a protocol deviation to the IRB?
• How do I obtain ancillary approvals, e.g., IT evaluation, Radiation Use Committee?

Researchers often have questions about statistics in designing a study or analyzing data. Some statistical questions can be easily answered in a short conversation with a knowledgeable statistician. In order to efficiently and effectively meet the statistical needs of clinical and translational investigators at UC Davis, the CTSC - in collaboration with the UC Davis Comprehensive Cancer Center - maintain weekly "office hours" for statistical consultations. These office hours are an opportunity for investigators to consult with a statistician about the design, analysis or presentation of medical research studies in a friendly, informal setting.

Due to the popularity of this program, investigators wanting to attend one of the upcoming office hours are asked to reserve a spot in advance by going to

ctscbiostatisticsworkshop.acuityscheduling.com…

You may make a reservation up to 30 days in advance. In order to be able to adequately address each attendee's question, space is limited to 6. If time permits, we will take questions from attendees without a reservation

The NIH Data Management and Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.

This includes all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements.

Researchers are required to submit a DMS plan as part of their grant application. If you have questions about the new requirement, where to find DMS plan resources or get help reviewing your draft DMS plan. The CTSC has expertise and is offering office hour consultations on these topics.

To schedule an office hours consultation, send an email to cenavarro@ucdavis.edu.

Researchers often have questions about statistics in designing a study or analyzing data. Some statistical questions can be easily answered in a short conversation with a knowledgeable statistician. In order to efficiently and effectively meet the statistical needs of clinical and translational investigators at UC Davis, the CTSC - in collaboration with the UC Davis Comprehensive Cancer Center - maintain weekly "office hours" for statistical consultations. These office hours are an opportunity for investigators to consult with a statistician about the design, analysis or presentation of medical research studies in a friendly, informal setting.

Due to the popularity of this program, investigators wanting to attend one of the upcoming office hours are asked to reserve a spot in advance by going to:

ctscbiostatisticsworkshop.acuityscheduling.com…

Limit of 1 spot per week per project for up to 2 projects.

No Appointment Necessary, Drop-Ins Welcome
Complimentary assistance with
Studypages questions
 

GET HELP ON THE FOLLOWING:

• What is Studypages and how can I get started?
• What advanced features of Studypages can I discover?
• How can Studypages benefit my study?
• Is Studypages HIPAA compliant?
• Do I need to obtain IRB approval to use Studypages?
• How do I recruit subjects for my study?
• How do I track potential leads and/or enrollees for my study?
• How do I communicate with my participants?

Email general office hours questions to the CTSC Clinical Trials Recruitment Program at hs-clinicaltrials@ucdavis.edu.