Hot off the press!

New  2017 Research Rates (Cost Query Tool) are posted on the CTO B&B website

Updates in Clinicaltrials.gov MANDATORY Registration and Results reporting are posted on the CTO clinicaltrials.gov website

CTSA Consortium is working towards achieving a standardized training platform in Good Clinical practices and the necessary means to disseminate it across all consortium sites.

UC Davis CTSC realigned the educational offerings to match Competency Domains adopted by the CTSA Consortium and outlined in the COAPCR publication "Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional," by S.A. Sonstein et al.  Please note a competency domain attributed to each CRC 2.0 or 3.0 workshop.

 

All CRC 2.0 training  take place in Ed Bld, Room 2205

LMS registration is required

Open only to UC Davis employees

September 8

Ed Bld, #2205, 3-5 pm

Coverage Analysis based on the Clinical Research Budgeting and Billing Course (LMS course #09155)

Suzan Bruce, Clinical Research Coder, Clinical Trials Office

Required ACRP Module:Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials

CTSA Competency Domain: Study and Site Management

 

September 21

CTO Office Hours, 2-4pm at the Clinical Trials Office , 2921 Stockton Blved, Suite 1400. Bring your questions about study coordination, source documents, HIPAA compliance, EMR, budgets, Coverage Analysis. Consultation only. Should you need an additional help in preparing or reviewing documents, please submit a request using the Application for Resource Use.  

REDCap registration is required for the first few events

 

September 22

Ed Bld, #2205, 3-5 pm

IRB Submissions: Commonly seen mistakes and best practices

Mihaela Harris/ Nicole Walters, IRB Administration

Required ACRP Module: Ethics and Human Subject Protection (or) GCP Test Out Challenge

CTSA Competency Domain: Ethical and Participant Safety Considerations

October 6

Ed Bld, #2205, 3-5 pm

Source Documents and Regulatory Binders

Lisa Wilson, Regulatory Lead/ Mark Alger, CRC, Clinical Trials Office

Required ACRP Module: ICH Gap Analysis Tool

CTSA Competency Domain: Clinical Trials Operations

 

October 20

Ed Bld, #2205, 3-5 pm

Hands on EMR Research Functionalities practice

Katrina Wheeler, Sr. CRC/ Siobhan Vasquez, CRC, Clinical Trials Office

ACRP module is not required

CTSA Competency Domain: Study and Site Management

November 3

Ed Bld, #2205, 3-5 pm

Budgets for Industry Trials

Julie Calahan, Budget Analyst, Clinical Trials Contracts/ Suzan Bruce, Clinical Research Coder, Clinical Trials Office

Required ACRP Module:  Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets That Make Sense

CTSA Competency Domain: Study and Site Management

 

November 17

Ed Bld, #2205, 3-5 pm

Coverage Analysis based on the Clinical Research Budgeting and Billing Course (LMS course #09155)

Suzan Bruce, Clinical Research Coder, Clinical Trials Office

Required ACRP Module:Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials

CTSA Competency Domain: Study and Site Management

December 1

Ed Bld, #2205, 3-5 pm

FDA and Sponsor Audits

Cindy Gates, IRB Director

Required ACRP Module: Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

CTSA Competency Domain: Clinical Trials Operations

 

 

 

January 5

Ed Bld, #2205, 3-5 pm

Hands on EMR Research Functionalities practice

Katrina Wheeler, Sr. CRC/ Siobhan Vasquez, CRC, Clinical Trials Office

ACRP module is not required

CTSA Competency Domain: Study and Site Management

 

January 11, 2017, 10am -12pm PST

Clinical Trials Brown Bag (Live Webinar)

Barnett International presents: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)

Description: The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials. Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided.

Learning objectives: • Identify the changes impacting investigator responsibilities and roles • Explain the impact of the revisions to sites and Sponsors-Investigators • Evaluate solutions for applicability/modification of organizational SOPs, processes, procedures and staff training • Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline .

THIS WEBINAR IS PRESENTED BY BARNETT (sponsored by the Clinical Trials Office).

YOU MUST ATTEND IN PERSON TO RECEIVE CEUs

CTSC Conference Room 1444, 2921 Stockton Blvd, Sacramento CA 95817  2.0 CTSC CEUs  

 

January 19

Ed Bld, #2205, 3-5 pm

Budgets for Industry Trials

Julie Calahan, Budget Analyst, Clinical Trials Contracts/ Suzan Bruce, Clinical Research Coder, Clinical Trials Office

Required ACRP Module:  Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets That Make Sense

CTSA Competency Domain: Study and Site Management

February 2

Ed Bld, #2205, 3-5 pm

Source Documents and Regulatory Binders

Lisa Wilson, Regulatory Lead/ Mark Alger, CRC, Clinical Trials Office

Required ACRP Module: ICH Gap Analysis Tool

CTSA Competency Domain: Clinical Trials Operations

 

February 16

Ed Bld, #3202, 2-5 pm  (three hours)

IRB Submissions: Commonly seen mistakes and best practices

Mihaela Harris/ Nicole Walters, IRB Administration

Required ACRP Module: Ethics and Human Subject Protection OR GCP Test Out Challenge

CTSA Competency Domain: Ethical and Participant Safety Considerations

March 2

Ed Bld, #2205, 3-5 pm

Hands on EMR Research Functionalities practice

Katrina Wheeler, Sr. CRC/ Siobhan Vasquez, CRC, Clinical Trials Office

ACRP module is not required

CTSA Competency Domian: Study and Site Management

 

March 16

Ed Bld, #2205, 3-5 pm

Budgets for Industry Trials

Julie Calahan, Budget Analyst, Clinical Trials Contracts/ Suzan Bruce, Clinical Research Coder, Clinical Trials Office

Required ACRP Module:  Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets That Make Sense

CTSA Competency Domain: Study and Site Management

April 6

Ed Bld, #2205, 3-5 pm

IRB Submissions: Commonly seen mistakes and best practices

Mihaela Harris/ Nicole Walters, IRB Administration

Required ACRP Module: Ethics and Human Subject Protection (or) GCP Test Out Challenge

CTSA Competency Domain: Ethical and Participant Safety Considerations

 

April 20

Clinical Trials Brown Bag

Insights on Effective Communication & Outreach Among Patients and Advocacy Groups (PPT)

www.readytalk.com  Access Code 7039177

Objectives:

1. Highlight key success factors and challenges of community engagement activity

2. Examine one of CISCRP’s educational and outreach initiatives and how key learnings can be applied to new initiatives

Presented by Ellyn Getz, Senior Manager of Development and Community Engagement, CISCRP. The Center for Information and Study on Clinical Research Participation (CISCRP) was founded in 2003, and is a non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. As part of its mission, CISCRP provides a variety of award-winning resources, programs and services that are designed to assist clinical research stakeholders in understanding public and patient attitudes and experiences in research as well as improving volunteer participation experiences and satisfaction.

May 4

Ed Bld, #2205, 3-5 pm

Source Documents and Regulatory Binders

Lisa Wilson, Regulatory Lead/ Mark Alger, CRC, Clinical Trials Office

Required ACRP Module: ICH Gap Analysis Tool

CTSA Competency Domain: Clinical Trials Operations

 

May 4

CTO Virtual Open House

CTSC and Yuzu Lab lauch StudyPages for participant recruitment (PPT)

www.readytalk.com  Access Code 7039177

UC Davis CTSC and Yuzu labs entered in agreement to provide on-line customized webpages for UC Davis studies, share them with target communities, track recruitment, and communicate with prospective study participants by secure e-mail, study-specific phone or SMS. Participant management platform is a powerful tool that allows you to keep a log of study-specific communication with prospective study participants, make notes, and export lists. The participant management features are available with or without the public-facing interface .

Visit UC Davis website: www.studypages.com/ucdavis

Functionalities include:

  • New! IRB HRP-14 On line clinical trials listings
  • Sign-ups and patient management workflow
  • Recruitment Database
  • SMS and Email communication tools
  • Image, Video, links, and PDFs
  •  Social sharing buttons
  •  PI profile  

 

May 20

Ed Bld, #2205, 3-5 pm

FDA and Sponsor Audits

Cindy Gates, IRB Director

Required ACRP Module: Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

CTSA Competency Domain: Clinical Trials Operations