Sirtex Mission: To improve the quality and
longevity of patients’ lives by providing innovative
interventional oncology solutions.

The Sirtex ISR program is open to all researchers who are interested in conducting their own research. This grant type is used as support for pre-clinical, clinical studies including post marketed research, including interventional and non-interventional, that involve a Sirtex asset or areas of interest. Sirtex will not support studies that are completed or already started, proposals that are conditioned upon past or future prescriptions or purchases of Sirtex products, or requests that create a conflict of interest with Sirtex Clinical Development programs.

ISR grants are only to further the scientific research and knowledge within a particular therapeutic area, and may be used to better understand risk/benefit profile of a Sirtex asset or to address an unmet medical need. ISR grants cannot be provided for the purpose of gaining experience with a Sirtex asset or treatment protocol. It is also important to note that ISR support may not be given to pay for the recipient’s ordinary operating expenses (i.e. expenses of activities that the recipient is already required to perform or customarily performs).

ISR proposals must be submitted at least 120 days prior to the predicted study start date. Proposals are reviewed by an internal review committee comprised of Sirtex medical, clinical, regulatory, and legal personnel. Decisions are based upon criteria such as scientific and strategic merit, safety, legal, ethical, and budgetary concerns.

Following each phase of the process, formal notification will be sent to the Investigator once a decision has been reached. Should additional information be needed for the committee to decide, a request for additional information will be issued.

Support of a study is only provided in response to an unsolicited written request. Sirtex ISR support is not conditioned on the use, purchase, prescription, or recommendation of any Sirtex products. Submission does not imply or guarantee approval for support. Sirtex may withdraw support if an Investigator fails to comply with applicable legal and/or regulatory obligations, provides false information in the proposal, or otherwise as specified in the contract.

As the Sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study. 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. Please review the below listed responsibilities of the investigator to ensure you are willing to meet the requirements prior to requesting support. This list is not all-inclusive and will change based on specific types of research grants.

• Study design and protocol development
• Institutional and regulatory approvals and reporting
• IRB/EC approval
• Registration on ClinicalTrials.gov or equivalent
• IND/IDE application submission (if applicable)
• Serious Adverse Event and Adverse Event reporting and reconciliation
• Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
• Communication of all ongoing study updates, including but not limited to:
  • Amendments to the study protocol
  • Regulatory and IRB/IEC continuing reviews
  • Serious adverse events reports
  • Achievement of study milestones related to milestone payments
  • Subject enrollment progress
  • Budget Reconciliation
  • Product Reconciliation
• Clinical study report (CSR) submission and/or Publication
  • Investigators should follow the FDA and ICH E3 Guidance for Structure and Content of Clinical Study Reports.
  • Investigators must 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 (ICMJE) guidelines.
  • Sirtex will not be involved in authorship selection, publication content or writing, and should never be listed as a co-author.

In comparison, Sirtex will assume the following responsibilities:

• Review (NOT approval) of the Research Protocol
• Distribution of updated, approved product information
• Review (NOT approval) of protocol amendments

To submit a proposal for evaluation, the submitter is required to create and access a Sirtex portal account, complete a submission form, and attach required documents. A complete and detailed submission will facilitate efficient management and evaluation.

• Study Concept or Complete Protocol
• Principal Investigator's Curriculum Vitae
  • Including evidence of GCP training
• Principal Investigator's Medical License
• Budget
• Other supporting documentation, as applicable

Incomplete submissions that do not include the required documents will not be processed until all requested information is received.