Orthopaedics & Robotics

As the sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study.

• Study design and protocol development
• Institutional and regulatory approvals and reporting
  • IRB/EC approval
  • Registration on ClinicalTrials.gov
  • IND/IDE application submission
  • Serious adverse event reporting to the FDA, IRB, and Smith+Nephew
• Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
• Communication of all ongoing study updates (see section below)
• Reconciliation and closeout reporting (see section below)
• Clinical study report submission within 90 days of study completion
• Dissemination of study results in a peer-reviewed publication and/or at a medical meeting within 6 months of study completion

The Investigator needs to complete a study proposal and budget, these will be provided once you have selected the relevant study type below.

Support is awarded based upon scientific merit, as well as alignment with our research areas of interest and availability of resources. We may provide research grants in the form of funding, and/or study product.

It can take approximately 6 to 8 weeks for a proposal to be approved, but may be longer in certain circumstances. Once submitted, a review of your proposal will take place including initial proposal and budget review, before moving on to an in-depth departmental review.

Once approved the contracting process can take up to 3 months depending on the Institution’s internal contracting process. The Investigator should not commence work on a proposal until a fully executed contract is in place. All contracts are with the Institution not the Investigator.

S+N will provide all or partial funding for any IIS that has been approved. S+N would prefer to provide funding to cover the device cost, rather than provide devices, but it can be done if absolutely necessary. Investigators can not be paid directly. All funding is to the institution responsible for and housing the patient data. No exceptions.

The Investigator must notify Smith+Nephew of the following updates for ongoing studies:

• Amendments to the study protocol
• Regulatory re-approvals
• Serious adverse events reports
• Achievement of study milestones related to milestone payments
• Subject enrollment progress (e.g., first subject in, last subject in, last subject out, etc.)

A clinical study report (CSR) is required within 90 days of study completion. The CSR should be written in accordance with the ICH Guidance for Structure and Content of Clinical Study Reports. Please refer to our guidance document here. A CSR template is provided for you here.

Submission for publication in a peer-reviewed journal is required within 6 months of study completion. All publications should comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors.

Smith+Nephew at least 30 days in advance of submission for publication. Additionally, we must receive evidence of submission for publication no later than 6 months following completion of the study. For research support that includes funding, the final milestone payment is dependent on submission for publication or presentation of study results.

Benefits to you: Funding support for research interests, Opportunities to collaborate with peers by participating in multi-center S&N sponsored studies and Med Ed opportunities to attend advanced courses/conferences

Benefits to S+N: Evidence to guide strategic direction for the life of the product, Clinical data to support product claims & meet regulatory requirements