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 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?
How do I receive the CTSC Connections newsletter?
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

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 Services?

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 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?

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?

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 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 and Data Explorer tools.

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Q. How do I receive CTSC announcements?
A.
The CTSC sends out announcements of funding opportunities and events. To have your email address added to our listserv, send your request to CTSCmail@ucdavis.edu.

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Q. How do I receive the CTSC Connections newsletter?
A.
The CTSC publishes a newsletter twice yearly that features stories and information about UC Davis translational research. Editions are distributed by email and posted on our website; print versions are available. To have your email address added to our listserv, send your request to CTSCmail@ucdavis.edu.

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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 Health System 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  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 .

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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.
Non-UCDHS users will need a sponsor to complete the UC Davis Temporary Affiliate Form to create the Kerberos ID needed for REDCap authentication.

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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 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: Please review the material on this website for further clarification. 

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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 an intranet page (Staff).

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Biostatistics

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 12-1:30 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 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 Financial Consideration 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 several options for accessing statistical software for free or low-cost and these are listed under Biostatistic's Other 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. A research dietitian is available to assist investigators with nutrition requirements, food intake analysis, or participant education. 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 Health System 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 the UC Davis Health System.

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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 Karimeh Borghei at kborghei@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 Karimeh Borghei at kborghei@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 Karimeh Borghei at kborghei@ucdavis.edu.

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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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