Investigator initiated studies play a key role in answering important medical and scientific questions regarding Smith+Nephew's products. These clinical studies contribute towards enhancing the understanding of Smith+Nephew's products and their application, therefore improving patient care, and sparking new ideas for further research aimed at creating improved treatment for patients.
Investigator-initiated studies (IIS) are studies conceived, initiated, conducted and sponsored an individual investigator, institution, university, collaborative group, cooperative group or association. The Sponsor must ensure that all legal and regulatory requirements are met and that the study is conducted and managed in accordance with all applicable laws and regulations.
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A clinical study designed and initiated by an investigator, whereby Smith+Nephew provide funding (monetary or medical devices) but do not act as Sponsor. Any type of study design (qualitative/quantitative) can be an IIS as the design of the study and proposal submitted to Smith+Nephew for consideration comes directly from the Investigator/HCP.
In the event the IIS is to support indication expansion of a device (to support business strategy), the Sponsor/Sponsor-Investigator will need to provide Regulatory/Competent Authority approval (clinical trial authorisation) for the conduct of the study.
Definition from ISO14155: When an investigator initiates, implements and takes full responsibility for the clinical investigation, the investigator also assumes the role of the sponsor and is identified as the sponsor-investigator.
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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).
For study-specific items, or equipment that may be required, please provide a rental estimate from a vendor of
choice. Please note that we do not provide support for the following:
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Salary and/or benefit payments for Investigators or study staff
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Education/training activities
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Costs that are deemed in excess of fair market value
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Capital equipment purchases (associated rental fees will be considered)
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Construction funds to build new facilities
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.
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