Frequently Asked Questions
BROWSING PREFERENCE
When using this Sirtex Portal, it is preferable that you use a laptop or PC instead of a mobile device. It is
preferable that you use the most updated version of Google Chrome as a web browser.
CONTACT INFO
You can contact grants@sirtex.com with any questions that come up during
the process of your submission.
CREATE AN ACCOUNT
Click “Create Account” at the top of the landing page and fill out your information. Once submitted, you will
receive an email to verify the email address you provided. Follow the link included and enter the code provided
in the email. The system will then ask you to log in to finish the process. If you continue to have issues,
please contact grants@sirtex.com for assistance.
UNABLE TO CREATE AN ACCOUNT
If you are unable to register, that likely means there is already an account linked to the email address that
you are trying to register with. You must use a unique email to create an account.
If you are not receiving the verification email, check that you have entered your email address correctly and
that it has not been relegated to your spam, junk, or trash folders. If you continue to have issues, please
contact grants@sirtex.com for help.
LOGIN ISSUES
If you are having trouble logging in, you may be using incorrect login information. Click the “Forgot Password”
button and follow the instructions to enter your email address and the captcha code. You will then receive an
email with directions to reset your password.
ACCOUNT UPDATE
To update your account information, login to your account and click the “Edit Profile” tab fill out the
required information and then click “Update Profile.”
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:
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Study design and protocol development
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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 or equivalent
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IND/IDE application submission (if applicable)
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Serious Adverse Event and Adverse Event reporting and reconciliation
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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, including but not limited to:
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Amendments to the study protocol
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Regulatory and IRB/IEC continuing reviews
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Serious adverse events reports
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Achievement of study milestones related to milestone payments
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Subject enrollment progress
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Budget Reconciliation
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Product Reconciliation
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Clinical study report (CSR) submission and/or Publication
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Investigators should follow the FDA and ICH E3 Guidance for Structure and Content of Clinical Study
Reports.
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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.
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Sirtex will not be involved in authorship selection, publication content or writing, and should never be
listed as a co-author.
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.
Workflow
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.
What is the difference between a concept and a full proposal?
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.
- Complete submission form
- Attach required documents:
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Study Concept or Complete Protocol
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Principal Sponsor-Investigator's Curriculum Vitae
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Principal Investigator’s Medical License
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Evidence of Principal Investigator’s GCP training
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Budget (High Level) for Concepts or Budget (Detailed) for Full Proposals
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Other supporting documentation, if applicable
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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.
Submit
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