Any type of clinical research whereby an investigator/HCP approaches Smith+Nephew to ask for assistance (monetary or resource) to analyse and/or write up their existing data (external to Smith+Nephew) for publication or as a conference proceeding.
Requirements of The Sponsor investigator
As the sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study.
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Institutional and regulatory approvals and reporting
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IRB/EC approval
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Registration on ClinicalTrials.gov
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Serious adverse event reporting to Smith+Nephew and locally - according to Regulatory requirements in your country
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Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
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Communication of all ongoing study updates (see section below)
The Investigator needs to complete a study proposal and budget, these will be provided once you have selected the relevant study type below.
Agreement
If the full proposal is approved, a contract will be sent for execution between the investigator, and
Smith+Nephew. Support is contingent upon a fully executed contract, compliance with the terms and conditions
of the contract, and submission of the following required documentation:
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IRB/EC Approval Letter and Final IRB Approved Protocol
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IND/IDE Application Submission to FDA, if applicable
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Registration on ClinicalTrials.gov, if
applicable
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Institutional Sub-W9
Budget
We will consider reasonable requests for funding in support of an IIS. All full proposal submissions must
include an itemized budget with costs a template will be available within the submission form if needed. Requestors may use their own template or the Smith+Nephew template that is provided
here. Line item allocations should be specified for each aspect of the study, such as study start-up fees
(e.g., IRB submission), study visits (e.g., physical exam, vital signs, pregnancy test), and publication costs
(e.g., medical writer).
How To Apply
Researchers are invited to submit their concept proposal using the ‘Submit Proposal’
button. Each submission will be reviewed collectively by the Smith+Nephew Review Committee based on scientific merit and
alignment with corporate research, key business objectives and development plans.
Submission Confidentiality
By submitting materials for review, you agree that the information is not confidential, nor proprietary, and may be referred to a number of different persons at Smith+Nephew to determine the level of interest in supporting your request.
Disclosure of Support
Publications or other presentation of data derived from the IIS must be marked with an acknowledgement that the study was conducted with financial and/or in-kind support from Smith+Nephew, as a collaborator.
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