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

Submissions are accepted on a rolling basis. ISR full proposal submissions must be submitted at least 120 days prior to the predicted study date. Concept and full proposal submissions are reviewed generally on a monthly basis by an internal review committee comprised of Sirtex medical, regulatory, and scientific personnel. Decisions are based strictly upon criteria such as scientific 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 (this list is not all-inclusive and will need to be considered for specific types of research grants) of the investigator to ensure you are willing to meet the requirements prior to requesting support.

Investigator Sponsor Responsibilities:

• 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 concept or 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.

A concept is a synopsis. It has a general idea of the study design and specific sections such as objective, hypothesis, endpoints, target sample size, etc. that will provide the information necessary to allow our review team to assess.

A full proposal describes the objective, design, methodology, statistical considerations, and organization of a study. It necessitates a completely drafted protocol, which follows the requirements of the ICH E6 Guidelines.

1. Complete submission form
2. Attach required documents:
   1. Study Concept or Complete Protocol
   2. Principal Sponsor-Investigator's Curriculum Vitae
   3. Principal Investigator’s Medical License
   4. Evidence of Principal Investigator’s GCP training
   5. Budget (High Level) for Concepts or Budget (Detailed) for Full Proposals
   6. Other supporting documentation, if applicable
3. Submit proposal

Sirtex will send an email notification acknowledging receipt of submission.

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

After receipt of a complete application and review by the internal review committee, Sirtex will notify the submitter of the proposal review decision and initiate the next steps.