On-going Research Support and Progress Tracking
Prior to project launch, award recipients will be assigned a support team that will provide on-going scientific and logistical support and help address translational roadblocks that may arise. The support teams will be co-led by the Tufts CTSI Pilot Studies Program, Research Collaboration Team, and Research Process Improvement faculty and staff.
Additional Tufts CTSI service providers, including, but not limited to, biostatisticians, recruitment and retentions specialists, and informatics experts, may be involved on an as-needed basis. Award recipients will be expected to collaborate with their support teams by providing progress updates, presenting future plans for publication/results dissemination and subsequent grant submission based upon findings, and discussing any challenges they may face during project implementation.
At month 15-to-18 post-award, each research team will be required to make a presentation on its pilot project at a meeting open to the broader scientific community (e.g., Tufts CTSI Translational Research Day).
Reporting and Long-Term Outcomes Tracking
Award recipients will be required to submit an interim report, a final report, and a final invention statement and certification form (HHS 568). Tufts CTSI will provide report templates to be completed. Form HHS and its instructions are available here. The final report and the HHS 568 forms will be due within 90 days following the expiration or termination date of the award.
In addition, award recipients will be required to report study outcomes annually using an online tool for at least five years after the funding ends. Outcomes to be reported will include professional presentations, published manuscripts, subsequent funding applications and awards, research products and associated intellectual property protections, and activities to implement findings into clinical care or public health. Award recipient’s failure to complete annual reporting may preclude future Tufts CTSI funding to the award recipient and their organization, school, or department.
All publications, projects, posters, patents, trademarks, or other tangible outcomes resulting from Tufts CTSI’s funding and services must cite Tufts CTSI’s NIH CTSA award (UL1TR002544) and comply with the NIH Public Access Policy. Tufts CTSI relies on these citations as a critical performance measure when reporting annual productivity to NCATS. Detailed guidelines for citations are available here.
Tufts CTSI will have funding available for journal fees, including publication processing and open access charges. Award recipients may request such support once a manuscript has been accepted for publication in a peer-reviewed journal. It will be made available for each research team within five years after the project end date provided they comply with the NIH Public Access Policy and appropriately cite Tufts CTSI’s NIH CTSA award. It will be limited to one eligible publication per research project.
Future Pilot Review Commitment
If invited, award recipients will be expected to serve as scientific peer-reviewers for the Tufts CTSI Pilot Studies Program and/or similar programs at collaborating CTSIs that are part of the CTSA External Reviewer Consortium II (Boston University CTSI, CTSI at Children’s National, Indiana CTSI, UCLA CTSI, and University of Kentucky Center for Clinical and Translational Science).
Over-expenditure, Carryover, and Project Extensions
Project budget may not exceed the approved amount. Tufts CTSI assumes no responsibility for over-expenditure. Any over-expenditure will be the award recipient’s department’s and/or organization’s responsibility. Carryover of expenses is not allowed. Funds not expended by April 30, 2021 will revert to Tufts CTSI. Project extensions are strongly discouraged, but will be considered on a limited basis at the discretion of Tufts CTSI. Such extensions will require renewal of all applicable institutional and regulatory approvals, including those of the funding agency, NCATS.