CTRC Resources (Timeline)

  • 1. Design

  • 2. Set-up

  • 3. Conduct

  • 4. Close-out/Publications

Design (pre-funding)

  •   Guidance: CTRC Facilitator

    We strongly suggest that you contact one of our Facilitators as the first step to design and implement your research study.

    Read more

  •   Funding Opportunities

  • Identify Collaborators:   eagle-i    VIVO

  •   Biostatistics and Study Design

    Study Design and Biostatistics (SDAB) provides planning and analytics services, whic include study design, sample size estimation, analysis panning, as well as production of statistcal reports and graphical displays.

    Go to SDAB

  •   Budgeting

    Depending upon the study funding source, the CTRC may charge for some or all of the CTRC services. These charges generally are billed to your grant or to a research billing number (RBN) linked to your grant. These RBN's exist to help ensure that patient-related charges from research projects (such as chemistry panels, CBCs, etc.) are appropriately billed to the research project and are not charged directly to the research study participant.

     Details about the Adult CTRC charging policy (PDF)

     Details about the Pediatric CTRC charging policy (PDF)

    After your protocol has been reviewed by the CTRC Council, the next step is reviewing the budget at the budget committee. In the event that you are asking the CTRC to provide financial support for your study, we would like to ask you to provide us with budget information so that we can begin planning how the CTRC can best support your protocol by reviewing it at the budget committee.

    The CTRC Budget committee generally meets the second Tuesday of each month. Prior to the meeting, please provide us with the following if you have not already done so:

    • For NIH grants: please provide the budget justification and the internal detailed budget your business administrator developed. Salary information should be removed.
    • For non-NIH grants: please provide the budget justification and the internal detailed budget your business administrator developed. Salary information should be removed.
    • For industry sponsored awards (investigator initiated and non investigator initiated): please provide a copy of the budget as well as the contract. Again, salary information should be removed.
    • For unfunded grants: please contact the CTRC associate directors directly to discuss these further.
  •   IRB

Set-up (post-funding)

  •   Guidance: CTRC Facilitator

    The CTRC Facilitator Program is the single point of contact for all clinical and basic science research related questions for study start-up, study conduct, and throughout the duration of a project. Whether submitting a grant application, preparing to implement a study, looking for resources to use in your study (core lab services, model organisms, and more!) or just wanting to brainstorm about a study idea, it is important to contact the Research Navigator Program early.

    Read more

  •   IDS

    Investigational Drug Service (IDS) to prepare investigational agents for human use.

    Go to IDS

  •   Nutrition

    Nutrition Core: consisting of the Nutrition Assessment Unit and the Dietary Assessment Unit.

    A broad range of nutrition-related research services for investigators.

    Go to Nutrition Assessment Core

  •   Informatics

    Informatics Services: resource to investigators in designing and developing a cohesive data management plan and/or database.

    Go to Informatics Services

  •   Exercise Medicine Unit

    Designed to provide structured exercise training interventions, exercise testing, and other related core services; staffed by a full-time exercise trainer.

    Go to Exercise Medicine Unit

  •   Cardiovascular Phenotyping Unit

    Cardiovascular Phenotyping Unit services include cardiovascular ultrasound, stress echocardiography, tests of arterial structure/function, cardiovascular phenotyping during exercise, and mitochondrial function testing.

    Go to Cardiovascular Phenotyping Unit

  •   Specimen Management

  •   Biomarkers

    Translational Core Laboratories

    Lab subcores include:

    • Specimen Collection/Point of Care Testing/Sample Disposition Lab
    • Molecular Biology and Cell Culture Labs
    • Biochemistry/Genetics Lab

    Go to TCL

  •   Research Nursing

    Research Nursing Core (RNC): Support for inpatient and outpatient clinical research by nurses with extensive experience.

    Go to RNC

  •   MyCTRC

  •   Register your trial: Clinicaltrials.gov

Conduct

  •   Guidance: CTRC Facilitator

    The CTRC Facilitator Program is the single point of contact for all clinical and basic science research related questions for study start-up, study conduct, and throughout the duration of a project. Whether submitting a grant application, preparing to implement a study, looking for resources to use in your study (core lab services, model organisms, and more!) or just wanting to brainstorm about a study idea, it is important to contact the Research Navigator Program early.

    Read more

  •   Subject Recruitment

  •   Audits

    Office of Clinical Research: office designed to assist with compliance of regulatory guidelines and study audits to investigators conducting translational and clinical research within the framework of the CTSA.

    Go to OCR

Close-out

  •   Guidance: CTRC Facilitator

    The CTRC Facilitator Program is the single point of contact for all clinical and basic science research related questions for study start-up, study conduct, and throughout the duration of a project. Whether submitting a grant application, preparing to implement a study, looking for resources to use in your study (core lab services, model organisms, and more!) or just wanting to brainstorm about a study idea, it is important to contact the Research Navigator Program early.

    Read more

  •   Study Closeout Guidelines

    After enrollment is closed, all follow-up data has been collected, and utilizing participant PHI is no longer required, the study is considered to be in the Closeout Phase. During this phase data is prepared for final analysis, regulatory and reviewing bodies are notified of study closure, investigational product inventory is reconciled, and final reports are submitted.

    For additional information on study closeout activities reference:

    Notification of study closure to review entities:


    Clinical and Translational Research Center (CTRC) Close Out

    While the initial CTRC submission and all continuing reviews should be done at the same time as the IRB submission, as they both use the HS-ERA system, CTRC study close out can typically be done prior to IRB close out.

    CTRC study closure can be done when:

    • Investigator determines that they will no longer need to utilize CTRC services.
    • When active subject participation has ended and the study is in data analysis only.

    For questions regarding CTRC study closure please contact CTRChelp@uphs.upenn.edu. We will reply within 48 business hours.

    Storage and Archiving:

  •   Acknowledge CTRC Grant Support in Manuscripts

    Please remember to cite the CTSA/CTRC grant on publications resulting from work on this protocol conducted at the CTRC as follows:

    "The project described was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR000003. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."

    Please send a copy of any publication addressed to Carl Shaw (Research Subject Advocate, shawcarl@mail.med.upenn.edu) and the CTRC Business Manager, Charles Molli, cmolli@exchange.upenn.edu.

  •   Biostatistics

  •   NIH Public Access Policy