Frequently Asked Questions (FAQs)

General

How do I get help navigating through CTSC resources?
How do I request CTSC services?
How do I find other research resources?
How do I describe CTSC resources in a grant application?
How do I request a CTSC letter of support?
How do I cite the CTSC grant in my manuscript?
How do I comply with NIH Public Access Policy?
How do I find CTSC seminars, training, and events?
How do I receive CTSC announcements and monthly e-newsletters?
How do I find the CTSC Clinical Research Center (CCRC)?
How do I learn more about the CTSA program?
What is translational science?
What are the page limits for NIH documents?
What is NIH’s definition of a Clinical Trial?

Biostatistics, Epidemiology, and Research Design

How do I get biostatistics support?
What biostatistics services are provided through the CTSC?
How much does biostatistics support cost?
At what phase of the research process should I request biostatistical support?
I need to conduct some analyses, but don’t have any statistical software. Can I access any statistical software at the CTSC?
I know the analyses I need to do but am having trouble running them in a particular software package. Can you help me with the programming? 

Bioethics

What is bioethics and research Ethics?
What are the kinds of issues that the service can support?
Who staffs the Research Ethics Consultation Service?

Biomedical Informatics

  • REDCap

Why use REDCap?
How do I request to create a study in REDCap?
How do I request an account for a project staff member?
Can I give access to external staff?
How secure is REDCap?
Is there a cost to using REDCap?
Is RedCap 21 CFR Part 11 compliant?

  • Cohort Discovery

How can I get access to Cohort Discovery?
Can fully-identifiable search results be obtained?
How do I change my password for Cohort Discovery?
What do I do if I don't get the results I expected form my queries?
Is there a way to revise a previously created query?
How often is the data in Cohort Discovery refreshed?
Can fully-identifiable search results be obtained?
Where can I learn more about Cohort Discovery?
What do I do if the term I am looking for is not listed under the Ontology root folder?
How do I reference Cohort Discovery/i2b2 for Methods and Grants?

Clinical Research Center

Who is eligible to use the CCRC?
What CCRC resources are available?
What kind of research can the CCRC support?
Are non-M.D.s allowed to conduct studies at the CCRC?
What if there are revisions to the original approved protocol or consent?
Does the CCRC have funds for ancillary testing?
What type of financial support is required to conduct a study at the CCRC?
Is there a fee for using these services?
How do I access the services of the CCRC?
How are research participants scheduled?
Other Inquiries?

Research Training, Education, and Career Development

  • CTSC TL1 Pre and Postdoctoral Clinical Research Training Program

If I apply to the CTSC TL1 training program, what is the duration of the program?
Does the TL1 program application for medical students limit the amount of information I can provide?
If I am accepted into the CTSC TL1 training program, what kind of funding may I expect?
Can I have more than one mentor?
If I apply to the CTSC TL1 training program, am I required to apply for the M.A.S. in clinical research?

  • CTSC KL2 Program

Can KL2 appointees apply for additional mentored K awards?
Is concurrent support allowable?
What are allowable expenses for KL2 research funds?
I do not have my junior faculty appointment yet. May I still apply?
What is the total number of years allowable for combined K funding?
What activities does the 75% protected time include?
May I negotiate to devote less than 75% effort to the KL2?
How can I best use the 25% non-supported effort?
I am the principle investigator of industry grants; am I eligible to apply for the KL2?
Can I work on several research projects under my 75% protected time?

  • Building Interdisciplinary Research Careers in Women's Health (BIRCWH) K12 Program

Can BIRCWH appointees apply for additional mentored K awards (i.e., K08 or K23)?
Is concurrent support allowable?
What are allowable expenses for BIRCWH research funds?
I do not have my junior faculty appointment yet. May I still apply?
What is the total number of years allowable for combined K funding?
What activities does the 75% protected time include?
May I negotiate to devote less than 75% effort to the KL2?
Can I work on several research projects under my 75% protected time?

  • Paul Calabresi Clinical Oncology K12 Program

Can Paul Calabresi Clinical Oncology K12 appointees apply for additional mentored K?
Is concurrent support allowable?
What are allowable expenses for Paul Calabresi Clinical Oncology K12 research funds?
I do not have my junior faculty appointment yet. May I still apply?
What is the total number of years allowable for combined K funding?
What activities does the 75% protected time include?
How can I best use the 25% non-supported effort?
I am the principle investigator of industry grants; am I eligible to apply for the K12 program?
Can I work on several research projects under my 75% protected time?

  • Mentored Clinical Research Training Program (MCRTP)

How do I apply to the MCRTP?
Why do I need to submit an undergraduate transcript?
If I am accepted into the MCRTP program, what kind of funding may I expect?
Can I have more than one mentor?
What if my primary and secondary mentors want to submit one joint letter of support?
What is the timeline for review and notification of selection?

  • Mentoring Academy for Research Excellence (MARE) Individual Development Plan Online Application

Why can't I access the mentee dashboard?
I am a mentor, but I cannot access the dashboard.
I am not able to edit my IDP.
My IDP was returned. What should I do next?
How can I print or email a copy of my IDP?
The primary center affiliation select list on Step 2 is blank.
My additional mentor is listed on my IDP, but they say they cannot access the mentor dashboard.
I’m an additional mentor but I cannot update the IDP’s status.

  • Program Access

What formal training programs exist for clinical and translational research?
Are degree or certificate programs available?
I am a scholar/fellow or director of a research training program or a clinical fellowship program. Can I or my program trainees access your offerings?
How much are course fees?
I'm a faculty member who plans to submit a training grant application. Can I include your offerings?
I am a faculty member wanting to get involved in research education and training. Do you need help?
I am not a UC Davis affiliate. Can I apply to your programs?
Where can I find information about other UC Davis courses?
Where can I find information about other health science certificate programs at UC Davis?
Are there programs that provide exposure to and prep for research related, non-faculty careers?

NIH Public Access Policy

My article is listed on PubMed. Why is it noncompliant?
What is the difference between the final peer-reviewed manuscript and the published article?
How can I get help with getting my article compliant with NIH Public Access Policy?

Pilot Program

What is the CTSC Pilot Program?
How do I apply for a CTSC Pilot project? 
What are the basic elements of CTSC Pilot applications?

General

Q. How do I get help navigating through CTSC resources? 

A. Contact the CTSC Concierge to:

  • Arrange for a consultation about CTSC services
  • Check on the progress of requests for CTSC services
  • Get assistance with the process for the NIH Public Access Policy for publications
  • Schedule a presentation about CTSC services for your department or group
  • Locate forms, documents and information on the CTSC website
  • Provide questions and comments about CTSC services

There are two primary ways to access the CTSC Concierge Service:

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Q. How do I request CTSC services?
A.
Most requests are submitted through the “Request Services” link on the top navigation bar on the CTSC website or by clicking the “Request Services” button on each of the CTSC Program pages.
Requests for the Research Bioethics service are made by directly contacting the Research Bioethics director, Mark Yarborough, at mayarborough@ucdavis.edu .

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Q. How do I find other research resources?
A.
The CTSC provides access to a wide variety of Facilities, Cores, and Resources .

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Q. How do I describe CTSC resources in a grant application?
A.
Boilerplate text for grant applications is provided on the CTSC website.
Included are descriptions for:

  • Clinical and Translational Science Center
  • Biomedical Informatics
  • Biostatistics, Epidemiology, and Research Design
  • Clinical Research Center
  • Community Engagement
  • Pilot Translational and Clinical Studies
  • Regulatory Knowledge and Support
  • Research Ethics
  • Research Education, Training, and Career Development Program
  • Translational Technologies, Methodologies, and Resources

To be sure you have accurate information about resource availability and cost to include in the budget, it’s important to discuss your project with CTSC staff BEFORE submitting a grant application.

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Q. How do I cite the CTSC grant in my manuscript?
A.
Text for attributing the use of CTSC resources in manuscripts and presentations is provided on the CTSC website.

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Q. How do I request a CTSC letter of support?
A.
The CTSC encourages collaborations with research projects and grants that align with our mission. For instructions on requesting a CTSC letter of support please visit Boilerplate Text for Letters of Support and Grant Applications.

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Q. How do I comply with NIH Public Access Policy?
A.
The NIH Public Access Policy requires that manuscripts citing the CTSC grant(s) be submitted electronically to PubMed Central upon acceptance for publication. Failure to do so may delay the processing of all grant awards linked to the article. Visit the NIH Public Access page to learn more about this policy.

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Q. How do I find CTSC seminars, training, and events?
A. The CTSC maintains an event calendar on its website. The CTSC Biomedical Informatics program offers training sessions on creating REDCap databases and using the Cohort Discovery tool.

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Q. How do I receive CTSC announcements and monthly e-newsletters?
A.
The CTSC sends out monthly e-newsletters and periodic announcements with information about upcoming events and funding opportunities. Sign up to receive these communications at http://eepurl.com/hvqa5r.

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Q. How do I find the CTSC Clinical Research Center (CCRC)?
A.
The CTSC Clinical Research Center (CCRC) is located on the UC Davis Health campus. 
Cypress Building
2221 Stockton Blvd., Suite D
Sacramento, CA.
Map and Directions
Visit the CCRC web page and download the program brochure to learn more about services offered at this new location. We also have a patient brochure (PDF) that provides practical information for those participating in clinical studies at the CCRC.

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Q. How do I learn more about the CTSA program?
A.
For more information about the CTSA program, please watch this short video. For additional information visit the NCATS website.

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Q. What is translational science? 
A. The CTSC focuses on translation of scientific discovery into treatments and cures to improve human health. For more information visit NCATS. Also available as a PDF PDF icon.

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Q. What are the page limits for NIH documents?
A.
Page limits can be found here for NIH documents.

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Q. What is NIH’s definition of a clinical trial?
A. Please review the material on this website for further clarification.

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Bioethics

Q. What is Bioethics and Research Ethics?
A.
Bioethics is the study of moral issues in the life sciences, including clinical medicine and biomedical research. A major domain in the field, research ethics, studies a range of issues that relate to the ethical conduct of biomedical research. From a historical perspective, most work in the field focused on issues central to the ethical conduct of clinical research, such as refining the informed consent process; assuring that benefits outweigh risks; and ensuring the just distribution of the burdens and benefits of research across the population. More recently, matters such as the ethical implications of obtaining and using genetic and genomic information, creating biospecimen research repositories, mapping the human brain, and conducting comparative effectiveness research have gained prominence.

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Q. What are the kinds of issues that the service can support?
A.
Examples of the kind of questions that the consultation service might assist with include, but are not limited to, the following:

  • Am I confident that the anticipated benefits of my research will outweigh its risks?
  • How do I know if the consent process that I plan to use for my research is the most appropriate one, given the special characteristics of my research population?
  • Should I do anything about the fact that my research is controversial in the eyes of many in the public?
  • How should authorship be assigned on manuscripts?

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Q. Who staffs the Research Ethics Consultation Services?
A.
The service is staffed by faculty affiliated with the UC Davis Bioethics Program. It may also draw upon clinical and other investigators with significant research ethics expertise.

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Biomedical Informatics

REDCap


Q. Why use REDCap?
A.
REDCap is a useful tool for data collection for the following reasons: accessibility, security, ease of use (no programming experience required), quality control, flexibility, and autonomy.

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Q. How do I request to create a study in REDCap?
A.
Complete the online CTSC Service Request and check “Biomedical Informatics/Data Collection and Management” resources on the opening page and “Build Electronic Data Capture and Forms” in the resulting dropdown menu.

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Q. How do I request an account for a project staff member?
A.
Submit a Service Catalog Request:

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Q. Can I give access to external staff?
A.
Yes, submit a Service Request for REDCap access for external staff.

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Q. How secure is REDCap?
A.
Software set-up is managed by UC Davis, with encrypted and secure servers.

  • HIPAA protocols compliant 3-tiered access:
  • System login
  • Project access
  • User restrictions

Audit trails (logging feature)
De-identified data (Can identify variables as PHI and export module with de-identifying option)

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Q. Is there a cost to using REDCap?
A.
There is no charge for basic level of support. Introductory training is provided to enable researchers to build their own database in REDCap. Charges incur if the Biomedical Informatics team develop the project from start to finish and when a high rate of support is required.

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Q. Is RedCap 21 CFR Part 11 compliant?
A. This web page is provided by the CTSC as a guideline for people using the CTSC REDCap instance. We stress that this is a guideline and not a legally binding document or a guarantee.

Short Answer

Yes, you can possibly use any project(s) in the CTSC REDCap instance as the database part of your study in order to adhere to Part 11 compliance. However, you will need to implement the additional necessary procedures yourself in order to become fully compliant. Please read the details below.

Long Answer

REDCap is 21 CFR Part 11-ready, meaning that if implemented in conjunction with appropriate procedures, documentation, and qualification, then your study may meet Part 11 requirements. However, compliance depends on the setting, which includes both the technical aspects of the installation and maintenance, quality requirements (Implementation Quality (IQ), Operational Quality (OQ), and Production Quality (PQ)), as well as the essential processes that must be put in place by users.

To be clear, 21 CFR Part 11 compliance requires compliance on two fronts: (a.) the CTSC side, which includes REDCap and (b.) the user side, which is outside the purview of the CTSC.

The CTSC has provided a secure environment for REDCap instances, which are frequently upgraded and backed up daily to a secure site. Login accounts to these instances are provided and monitored by CTSC personnel. Logins are provided to personnel of the CTSC partner institutions and organizations affiliated with the CTSC or its partner institutions.

Details about the general REDCap security features that may support Part 11 compliance can be found in the “About REDCap” document released by Vanderbilt University. 

For CTSC policies supporting our REDCap instance, see below:
On the user side, the individual user or study team is also responsible for ensuring compliance, including establishing appropriate standard operating procedures to protect and document data.  Many of the activities encouraged by Part 11 are good practice in general, including explicit definition of study team roles and responsibilities, database change control and documentation, and record retention.  Personnel training commensurate with responsibilities is also required.

FDA guidance on 21 CFR Part 11 compliance in the context of clinical studies is available on the Food and Drug Administration (FDA) website. Guidance documents are searchable, and the following are suggested reading:

  1. Part 11, Electronic Records; Electronic Signatures – Scope and Application, published 8/2003.
  2. Computerized Systems Used in Clinical Investigations, published 5/2007.

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Cohort Discovery

Q. How can I get access to Cohort Discovery?
A. Complete the Cohort Discovery Introductory Training Sessionand submit a signed Cohort Discovery Confidentiality Agreement to hs-cohortdiscovery@ucdavis.edu.

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Q. Can fully-identifiable search results be obtained?
A. Yes. Submit a request to the IRB. The extent of identifiable data that will be provided is determined by IRB approval. Please submit a Service Request for Research Data Fulfillment.

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Q. How do I change my password for Cohort Discovery?
A. To change your password, please call the Help Desk (916) 735-HELP (4357). Your login credentials will be the same as your Kerberos ID and passphrase.

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Q. What do I do if I don't get the results I expected form my queries?
A. Notify your Cohort Discovery Support Team by email at hs-cohortdiscovery@ucdavis.edu. Please provide as much information as possible about your query so that we can quickly get back to you with information about the result.

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Q. Is there a way to revise a previously created query?
A: Yes, simply drag and drop the previous query to the Query Name field and then alter the search parameters to suit your research needs. However, once the query is run the system will assign the query a new name.

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Q. How often is the data in Cohort Discovery refreshed?
A. Cohort Discovery data is refreshed monthly.

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Q. Can fully-identifiable search results be obtained?
A. Yes. Submit a request to the IRB. The extent of identifiable data that will be provided is determined by IRB approval.

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Q. Where can I learn more about Cohort Discovery?
A. Additional information is provided on Cohort Discovery page.

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Q. What do I do if the term I am looking for is not listed under the Ontology root folder?
A. If the term you are looking for is not listed under the Ontology root folder then users can try to conduct a search using the options available under the Find Terms tab, or contact a Faculty Champion for more information.

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Q. How do I reference Cohort Discovery/i2b2 for Methods and Grants?
A. Please refer to information located at Boiler Plate Text for Grants.

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Biostatistics, Epidemiology, and Research Design

Q. How do I get biostatistics support?
A. There are two primary ways to get biostatistics assistance from the CTSC. 
We hold Office Hours every Tuesday from 12-2 p.m. at the CTSC in Sacramento. These sessions provide an opportunity for investigators to consult with a statistician about the design, analysis, or presentation of medical research in a friendly, informal setting, and to get referred for additional help if needed. Reserve a time slot through this web form.
Alternatively, you may request biostatistics assistance by submitting an online service request through the CTSC website. In this case, a statistician will be assigned to work with you individually on a short-term basis. Investigators who only need statistical advice are encouraged to attend Office Hours rather than to submit a formal service request.

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Q. What biostatistics services are provided through the CTSC?
A. CTSC biostatisticians can assist with study design/protocol development, sample size and power calculations, grant proposal preparation, statistical analysis plan development, analysis and interpretation of data, manuscript preparation and review (statistical aspects), response to reviewer comments, and DSMB participation. We can also provide guidance in database development from the perspective of ensuring that the correct data are collected for the study hypotheses and in a manner conducive to anticipated statistical analyses.

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Q. How much does biostatistics support cost?
A. The CTSC Biostatistics, Epidemiology, and Research Design program is supported in part by funding from the CTSA NIH grant and the UC Davis School of Medicine. This funding helps provide our infrastructure at the CTSC and allows us to provide some services without charge. As these funds cover only a small fraction of our expenses, cost recovery for statistical services is essential to sustaining the Biostatistics Program as a resource for all investigators. We provide up to 10 hours (2 hours for medical residents and students) of consultation without charge to investigators who do not have grant or departmental funding. Researchers with extramural funding must provide salary cost recovery for professional statistical services at a level commensurate with the available funding and level of effort. Our staff recharge rate is $89 per hour. Biostatistical assistance for grant proposals is provided free of charge. Grant proposals that require statistical assistance for preparation will usually require statistical services to accomplish the project goals, and we will assist with preparing the budget to provide an appropriate level of statistical support. Guidance on the level of effort to budget for statistical services is available on the Cost of Services page.

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Q. At what phase of the research process should I request biostatistical support?
A. We recommend consulting a biostatistician while developing the research plan or proposal to ensure that your study design is appropriate, cost effective, and will collect the data necessary to achieve study objectives. In addition, the biostatistician will determine the sample size necessary for valid statistical inference. Please submit an online service request at least 6 weeks before a grant proposal deadline to allow adequate time for thoughtful review and meaningful input.

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Q. I need to conduct some analyses, but don’t have any statistical software. Can I access any statistical software at the CTSC?
A. No. The CTSC does not maintain a computer lab or statistical software. There are several options for accessing statistical software for free or low-cost and these are listed under Biostatistic's Statistics Resources page.

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Q. I know the analyses I need to do but am having trouble running them in a particular software package. Can you help me with the programming? 
A. It depends. Our statisticians primarily use SAS and R and we can provide some limited assistance with programming in these languages. We are generally not able to assist with other software packages because we do not regularly use other packages. We strongly encourage users to invest time to understand their chosen software and to work through programming challenges on their own. For SAS, R, Stata and SPSS users, the UCLA website provides a wealth information on coding and interpretation of common statistical methods.

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Clinical Research Center

Q. Who is eligible to use the CCRC?
A.
The CCRC is available to UC Davis faculty, residents, postgraduate fellows, medical students, and nurses with an IRB-approved protocol.

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Q. What CCRC resources are available?
A.
Outpatient and inpatient nursing support, bionutrition, exercise physiology, regulatory, and laboratory services are available to investigators. Nursing services include investigational drug administration, serial blood sampling, monitoring, invasive procedure assistance, EKG or cardiac monitoring, and qualitative data collection. A nurse practitioner is on-site to provide additional services to investigators, such as history and physical exams, invasive procedures (i.e., biopsies), and bedside monitoring during high risk infusions. Our exercise physiologist is available to measure body composition, metabolic rate, bone density, other unique exercise-fitness testing, and participant education. A laboratory technician can assist with unique laboratory testing or processing needs. Services can be provided at the CCRC, the UC Davis Medical Center, other UC Davis Health locations, the UC Davis Campus, in patients’ homes, or at most other community-based locations.

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Q. What kind of research can the CCRC support?
A.
The CCRC supports human-based, multi-disciplinary clinical research. Participants may be healthy controls or diagnosed with an acute or chronic condition. We currently support studies from the following departments: internal medicine; internal medicine subspecialties, such as oncology, neurology, cardiology; surgery; radiology; epidemiology; obstetrics and gynecology; psychiatry; pediatrics; and nursing.

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Q. Are non-M.D.s allowed to conduct studies at the CCRC?
A.
Yes. Non-M.D. investigators, such as Pharm.D.s and Ph.D.s, may request our services.

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Q. What if there are revisions to the original approved protocol or consent?
A.
All protocol modifications and renewals, once approved by the IRB, should be forwarded to the CCRC coordinator so that we can ensure protocol compliance.

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Q. Does the CCRC have funds for ancillary testing?
A.
No. The CCRC does not have funds to cover any clinical testing performed. The CCRC can also assist investigators with the coordination for ancillary support throughout UC Davis Health.

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Q. What type of financial support is required to conduct a study at the CCRC?
A.
The CCRC can support investigator-initiated (department or grant-funded) and industry-sponsored research. It is important to get an estimate for these services when you are planning your budget.

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Q. Is there a fee for using these services?
A.
Yes. For current fees please email Christopher Kain at crkain@ucdavis.edu.
You will need to include estimated fees in your budget prior to approval of CCRC support. Any questions about this rate or its justification should be directed to Christopher Kain at crkain@ucdavis.edu.

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Q. How do I access the services of the CCRC?
A.
Simply complete an online Service Request.

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Q. How are research participants scheduled?
A.
Appointments are made via a fax scheduling process. This process will be reviewed with you during a “Start Up” meeting after your Service Request has been approved.

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Q. Other Inquiries?
A.
If you still have questions, please contact Christopher Kain at crkain@ucdavis.edu.

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Research Training, Education, and Career Development

CTSC TL1 Pre and Postdoctoral Clinical Research Training Program

Q. If I apply to the CTSC TL1 training program, what is the duration of the program?
A. If you are accepted into the CTSC TL1 training program you will be in the program for one year, which begins July 1 through June 30.

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Q. Does the TL1 program application for medical students limit the amount of information I can provide?
A. The information provided in the application should be clear and concise, as the reviewers will have several applications to review, but there are no limits on the amount of information or text for the training program application.

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Q. If I am accepted into the CTSC TL1 training program, what kind of funding may I expect?
A. Those selected for the CTSC TL1 training program, will receive a stipend, health insurance, and funds for research and travel expenses.

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Q. Can I have more than one mentor?
A. Yes, actually you are encouraged to have a mentoring team. All applicants are required to submit two letters of recommendation with their application; one letter from their primary mentor and an additional letter from another recommender or mentor.

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Q. If I apply to the CTSC TL1 training program, am I required to apply for the M.A.S. in Clinical Research?
A: No

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CTSC KL2 Program

Q. Can KL2 appointees apply for additional mentored K awards?
A. Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K07, K08, K22, K23) and independent awards (R01, R03, R21); if successfully funded, the KL2 appointment would be terminated.

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Q. Is concurrent support allowable?
A. Mentored K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award.  In the first year of their appointment, a KL2 scholar may commit effort but may not receive any other federally-funded salary support. However, in the final two years of their KL2 appointment, a KL2 scholar may reduce effort on the K award to a minimum of 6 person-months and may hold concurrent support from their K award and a competing PHS research grant on which they are the PD/PI or component lead. To be eligible for salary support from peer-reviewed research awards from any Federal agency:

  • The KL2 scholar must be one of the named PIs on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).
  • The KL2 scholar award must be active when the competing research grant application is submitted.
  • The KL2 scholar must be in their final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.

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Q. What are allowable expenses for KL2 research funds?
A. The following expenses are allowable: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) up to $2,500 for scholar travel to scientific meetings and research training workshops, and (d) statistical services. Please be advised that the research supplies budget must be administered under the current NIH directive with respect to clinical trial research. Your application must include a budget which will require approval prior to the start of your KL2 appointment. The approved budget can only be used to offset research costs that do not directly support clinical trials.

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Q. I do not have my junior faculty appointment yet. May I still apply?
A. A junior faculty appointment, as outlined in the Academic Personnel Manual Section 310, is required at the time of application. “In progress” appointments are not accepted.

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Q. What is the total number of years allowable for combined K funding?
A. Five Years

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Q. What activities does the 75% protected time include?
A. This protected time is for multidisciplinary clinical and translational research with training and mentoring activities.

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Q. May I negotiate to devote less than 75% effort to the KL2?
A. In general, 75% of the scholars’ full-time professional effort must be devoted to the program. However, certain surgical specialties may request approval for less than 75% if justified, but no less than 50% protected time for this program is allowed. Justification will require documentation that more than a 25% clinical commitment is required in order to avoid loss of competence or credentialing in specified clinical skills. Any applicant who is interested in applying while committing less than 75% effort for the academic aspects of the project should discuss their interests with the program director prior to applying.

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Q. How can I best use the 25% non-supported effort?
A. The scholar’s non-supported effort must be devoted to activities related to the development of a successful clinical and translational research career. Typically these activities include clinical, administrative, and/or teaching efforts. Divisions/departments must not require extra duties or responsibilities that reduce the scholar’s protected time and interfere with the purpose of the KL2 award. An audit may be conducted to ensure compliance.

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Q. I am the principle investigator of industry grants; am I eligible to apply for the KL2?
A. Yes, this is allowed as long as your paid effort is outside of the 75% KL2-supported effort.

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Q. Can I work on several research projects under my 75% protected time?
A. Yes, however, these research projects should all be aligned with your overall research theme, objectives, and specific aims. Since you will need to account for all of your time, you will want to address this in your application.

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Building Interdisciplinary Research Careers in Women's Health (BIRCWH) K12 Program

Q. Can BIRCWH appointees apply for additional mentored K awards (i.e., K08 or K23)?
A. Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K07, K08, K22, K23) and independent awards (R01, R03, R21); if successfully funded, the BIRCWH appointment would be terminated.

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Q. Is concurrent support allowable?
A. BIRCWH scholars are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award. In the first year of their appointment, BIRCWH scholar may commit effort but may not receive any other federally-funded salary support. However, in the final two years of their BIRCWH appointment, a BIRCWH scholar may reduce effort on the K award to a minimum of 6 person-months and may hold concurrent support from their K award and a competing PHS research grant on which they are the PD/PI or component lead. To be eligible for salary support from peer-reviewed research awards from any Federal agency:

  • The BIRCWH scholar must be one of the named PIs on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).
  • The BIRCWH scholar award must be active when the competing research grant application is submitted.
  • The BIRCWH scholar must be in their final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.

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Q. What are allowable expenses for BIRCWH research funds?
A. The following expenses are allowable: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) scholar travel to scientific meetings and research training workshops, and (d) statistical services.

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Q. I do not have my junior faculty appointment yet. May I still apply?
A. A junior faculty appointment, as outlined in the Academic Personnel Manual Section 310, is required at the time of application. “In progress” appointments are not accepted.

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Q. What is the total number of years allowable for combined K funding?
A. Five Years

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Q. What activities does the 75% protected time include?
A. This protected time is for multidisciplinary clinical and translational research with training and mentoring activities.

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Q. May I negotiate to devote less than 75% effort to the KL2?
A. In general, 75% of the scholars’ full-time professional effort must be devoted to the program. However, certain surgical specialties may request approval for less than 75% if justified, but no less than 50% protected time for this program is allowed. Justification will require documentation that more than a 25% clinical commitment is required in order to avoid loss of competence or credentialing in specified clinical skills. Any applicant who is interested in applying while committing less than 75% effort for the academic aspects of the project should discuss their interests with the PI/Program Director prior to applying.

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Q. Can I work on several research projects under my 75% protected time?
A. Yes, however, these research projects should all be aligned with your overall research theme, objectives, and specific aims. Since you will need to account for all of your time, you will want to address this in your application.

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Paul Calabresi Clinical Oncology K12 Program

Q. Can Paul Calabresi Clinical Oncology K12 appointees apply for additional mentored K?
A. Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K07, K08, K22, K23) and independent awards (R01, R03, R21); if successfully funded, the Paul Calabresi Clinical Oncology K12 appointment would be terminated.

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Q. Is concurrent support allowable?
A. Mentored K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award. In the first year of their appointment, a Paul Calabresi Clinical Oncology K12 scholar may commit effort but may not receive any other federally-funded salary support. However, in the final two years of their K12 appointment, a scholar may reduce effort on the K award to a minimum of 6 person-months and may hold concurrent support from their K award and a competing PHS research grant on which they are the PD/PI or component lead. To be eligible for salary support from peer-reviewed research awards from any Federal agency:

  • The K12 scholar must be one of the named PIs on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).
  • The K12 scholar award must be active when the competing research grant application is submitted.
  • The K12 scholar must be in their final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.

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Q. What are allowable expenses for Paul Calabresi Clinical Oncology K12 research funds?
A. The following expenses are allowable:

  • Research expenses, such as supplies, equipment, and technical personnel.
  • Tuition and fees related to required career development courses and activities;
  • Travel to scientific meetings or training; and
  • Statistical services including personnel and computer time. Costs must be specifically and directly related to the scholar's research activities.

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Q. I do not have my junior faculty appointment yet. May I still apply?
A. Paul Calabresi Clinical Oncology K12 scholars must hold a junior faculty appointment, as outlined in the Academic Personnel Manual Section 310. “In Progress” appointments are accepted for applicants, but appointments must be finalized prior to the start of the Paul Calabresi Clinical Oncology K12 appointment. Contact the program manager prior to submission with questions.

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Q. What is the total number of years allowable for combined K funding?
A. Five Years

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Q. What activities does the 75% protected time include?
A. This protected time is for multidisciplinary clinical and translational research with training and mentoring activities.

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Q. How can I best use the 25% non-supported effort?
A. The scholar’s non-supported effort can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the Paul Calabresi Clinical Oncology K12 program. Divisions/departments must not require extra duties or responsibilities that reduce the scholar’s protected time and interfere with the purpose of the K12 award. An audit may be conducted to ensure compliance.

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Q. I am the principle investigator of industry grants; am I eligible to apply for the K12 program?
A. Yes, this is allowed as long as your paid effort is outside of the 75% KL2-supported effort.

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Q. Can I work on several research projects under my 75% protected time?
A. Yes, however, these research projects should all be aligned with your overall research theme, objectives, and specific aims. Since you will need to account for all of your time, you will want to address this in your application.

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Mentored Clinical Research Training Program (MCRTP)

Q. How do I apply to the MCRTP?
A.
You will need the Clinical Research Graduate Group and the MCRTP Application Instructions.  Contact Connie Koog at cdkoog@ucdavis.edu and she will send them to you.  Note, you will simultaneously apply to both the Clinical Research Grad Group and the MCRTP.

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Q. Why do I need to submit an undergraduate transcript?
A.
Because you are applying to the Clinical Research Graduate Group and the system requires an undergraduate transcript to apply for an M.A.S. degree. Note, the MCRTP, does require documentation of your graduate work too.

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Q. If I am accepted into the MCRTP program, what kind of funding may I expect?
A.
Those selected for the MCRTP program, will not receive funding, but your M.A.S. course fees will be covered at no cost to you.

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Q. Can I have more than one mentor?
A.
Yes, actually you are encouraged to have a mentoring team.  All applicants are required to submit at least two letters of recommendation with their application; one letter from their primary mentor and an additional letter from their secondary mentor.  In addition, you must submit a letter of support from your department chair pledging a commitment of 70% release time for you.  You can have your department chair submit the letter in the application system as another recommender or you may have them send the letter directly to Connie Koog at cdkoog@ucdavis.edu.

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Q. What if my primary and secondary mentors want to submit one joint letter of support?
A.
The M.A.S. application online system requires at least two letters of support. You may submit the joint letter and then have your department chair submit the second letter.

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Q. What is the timeline for review and notification of selection?
A.
Typically, applications are reviewed in March and the selection notification will be made around mid April.

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Mentoring Academy for Research Excellence (MARE) Individual Development Plan (IDP) Online Application

Q. Why can’t I access the Mentee Dashboard?
A.
You must be a UC Davis faculty member with a record in the Faculty Information System to access the online IDP. If you are seeing an error when you try to access the mentee dashboard, it means that the system could not validate that you are a UC Davis faculty member. If you feel you are seeing this in error, contact the Mentoring Academy for Research Excellence for assistance.

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Q. I am a mentor, but I cannot access the dashboard.
A.
First, you must have a UC Davis login (Kerberos) to access the application. Second, in order to access the mentor dashboard there must be at least one IDP in the system for which you are assigned as one of the following: primary mentor or additional mentor. If there are no IDPs in the system for which you have one of these roles, you will not have access to the mentor dashboard.

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Q. I am not able to edit my IDP.
A.
Once an IDP has been acknowledged by your primary mentor it is considered final and can’t be edited. If you would like to make additional updates to an acknowledged IDP you can copy it and then you will be able to edit it and submit it for approval.

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Q. My IDP was returned. What should I do next?
A.
When you submit your completed IDP your primary mentor will review it. If they would like you to make some revisions, they will return it to you. Click on the “view reason” button from the mentee dashboard to read a short note about why the IDP was returned. Your primary mentor should also reach out to you to discuss the requested revisions in person. Once you understand why the IDP was returned, click on edit from the mentee dashboard and make the necessary updates. Then you can resubmit it for review. (Please note: The "view reason" button will disappear once you start making your revisions.)

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Q. How can I print or email a copy of my IDP?
A.
For mentees, once you have started an IDP it will appear as "in progress" on the mentee dashboard. Click on the "view" button to open a PDF version of that IDP. You can then print or email a copy of the PDF. (Please note: mentees can view any IDP regardless of the status. However, mentors are not able to view in-progress IDPs.)

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Q. The primary center affiliation select list on Step 2 is blank.
A.
This select list is populated from the Faculty Information System. If this list is blank, it is because the data is not populated in the Faculty Information System. Contact the Mentoring Academy for Research Excellence and let them know what the issue is so they can enter the missing data for you.

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Q. My additional mentor is listed on my IDP, but they say they cannot access the mentor dashboard.
A.
Only mentors, including additional mentors, with a Kerberos password may access the mentor dashboard. Please see the "how can I print or email my IDP" section for guidance on sending the completed IDP to your non-UC Davis additional mentor.

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Q. I’m an additional mentor but I cannot update the IDP’s status.
A.
Only the primary mentor and Mentoring Academy for Research Excellence staff, can update an IDP’s Status. Please contact the mentee directly with any edits.

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Program Access

Q. What formal training programs exist for clinical and translational research?
A. There are three programs that focus on mentored research experience coupled with program curricula and activities:

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Q. Are degree or certificate programs available?
A. Yes, the CTSC administers three graduate level programs in clinical and translational research:

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Q. I am a scholar/fellow or director of a research training program or a clinical fellowship program. Can I or my program trainees access your offerings?
A. Yes, usually, if the following criteria are met:

For course participation:

  • Trainees must meet the prerequisites for the course.
  • Prior approval from course instructor is required as some courses have space limitations.

Course fees must be paid by trainee or trainee’s department through one of two ways:

  • Registering and paying for the course(s) through the UC Davis Extension Open Campus Program (UC Davis employees get a 20% discount).
  • Registering through the regular campus course registration system if you are enrolled in a UC Davis graduate program.

For program activities such as Monthly Scholar Research presentations or Works in-Progress meetings:

  • Prior approval from the faculty program director(s) is required.

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Q. How much are course fees?
A. Course fees are as follows:

  • For graduate students enrolled in the Masters in Clinical Research program - $481/unit.
  • For graduate students enrolled in other UC Davis graduate programs – included in quarter tuition fees.
  • For scholars not enrolled in a degree program - $300/unit through Open Campus; (UC Davis employees are eligible for a 20% discount).

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Q. I'm a faculty member who plans to submit a training grant application. Can I include your offerings?
A. Yes! Before you submit your grant, please contact the CTSC Research Training, Education, and Career Development program for help in identifying the appropriate offerings for your proposed program.

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Q. I am a faculty member wanting to get involved in research education and training. Do you need help?
A.  Please contact the CTSC Research Training, Education, and Career Development program for more information.

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Q. I am not a UC Davis affiliate. Can I apply to your programs?
A. Mentored research training programs are open only to UC Davis affiliates. Non-UC Davis affiliates may apply to degree and certificate programs.

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Q. Where can I find information about other UC Davis courses?
A. View the course catalog for all courses.

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Q. Where can I find information about other health science certificate programs at UC Davis?
A. View other UC Davis Extension Certificate Programs:

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Q. Are there programs that provide exposure to and prep for research related, non-faculty careers?
A. Yes! The CTSC FUTURE program is a career exploration program designed for Ph.D. graduate students and postdocs. For more information contact the CTSC Research Education program or visit the FUTURE website.

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Pilot Program

Q. What is the CTSC Pilot Program?
A. The Pilot Program aims to spark innovative and collaborative scientific endeavors by supporting and facilitating robust new research paradigms, technologies, and tools, and through partnerships that enhance team science. The program seeks to solicit partnerships and leverage funds from other UC Davis pilot project programs.

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Q. How do I apply for a CTSC Pilot project? 
A. Several calls for proposals are announced each year. These announcements are posted on the website and circulated broadly to the campus community.

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Q. What are the basic elements of CTSC Pilot applications?
A. Competitive applications:

  • Represent new teams proposing highly innovative studies and that address a timely and critical human health-related topic
  • Provide strong rationale for need for funds in order to submit a well-defined extramural research grant application
  • Include trainees to advance the translational pipeline with exposure of the trainees to the CTSC education and training resources
  • Adhere to application requirements and are highly responsive to the call for applications
  • Address rigor and reproducibility and provide detailed budget justifications
  • Are succinct, compelling, and well-written

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NIH Public Access Policy

Q. My article is listed on PubMed. Why is it noncompliant?
A.
PubMed is a database of citations and abstracts for more than 26 million articles. PMC is an electronic archive of full-text journal articles, offering free access to its contents. PMC contains more than 3 million articles, most of which have a corresponding entry in PubMed.
Source: https://www.ncbi.nlm.nih.gov/pmc/about/faq/#q2
In fact, the journal Nature reports that authors’ failure to understand the difference between PubMed and PubMed Central is the most frequently offered reason for their noncompliant articles.
Source: http://www.nature.com/nm/journal/v19/n1/full/nm0113-3.html

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Q. What is the difference between the final peer-reviewed manuscript and the published article?
A.
The NIH Public Access Policy is based on a law that requires investigators to submit "their final, peer-reviewed" manuscripts to PubMed Central.
Final peer-reviewed manuscript: The Investigator's final manuscript of a peer-reviewed paper accepted for journal publication, including all modifications from the peer review process. 
Final published article: The journal’s authoritative copy of the paper, including all modifications from the publishing peer review process, copyediting and stylistic edits, and formatting changes.
Source: https://publicaccess.nih.gov/faq.htm#4060
Note: Galley proofs and other intermediate versions of the article created after acceptance by the publisher are not substitutes for the final peer reviewed manuscript.
Always retain a copy of the final peer-reviewed manuscript as you may need it to comply with public or open access policies.

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Q. How can I get help with getting my article compliant with NIH Public Access Policy?
A.
The easiest way for CTSC researchers and scholars to get help is to contact the CTSC Program Development Officer. We will:

  • Answer your questions
  • Determine the method your journal uses to help you comply with NIH Public Access Policy
  • Contact publishers on your behalf
  • Upload your final, peer reviewed manuscript to the NIH Manuscript Submission (NIHMS) system upon your request
  • Provide one-on-one or group assistance for any steps in the compliance process

 Investigators who have not used CTSC resources (for the research reported in their manuscripts) may use the NIH Public Access Policy support service provided by the Blaisdell Medical Library. Contact librarian Amy Studer at hs-nihpaphelp@ucdavis.edu.

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