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To avoid loss of data, please plan to submit your ISS form in its entirety within one login session. It is recommended that you review the form prior to actual submission to determine information being requested (submitted or cancelled forms cannot be retrieved).

Once you have gathered all of the required information, please allow at least 30 minutes to complete the form (the session will timeout within one hour from login). Should you require more time to complete your submission, please click the “Save” button at the bottom of this submission form. You will be able to re-login at a later point to complete your submission. Please Note: This form has some character limitations and may not recognize invalid characters. Copying/Pasting data may present compatibility limitations.

Additional information about your proposal may be provided in the Additional Information About Your Proposal section at the bottom of the form. Please note that the Sponsor Name is a required field, however, if you identify any other field(s) not relevant to your submission, please type “Not Applicable” or NA. Also, if your proposal already exists in an alternate format or document, in addition to completing the other requested information in the form, you may provide Attachments at the bottom of this web page.

By submitting this form you are attesting that you, or any anticipated ISS sub-sites/investigators, are not participating in an Amgen Clinical Development study with the same patient population.

Thank you for your ISS submission to Amgen.

Amgen has received your ISS web application and upon evaluation for completeness will provide you with acknowledgement of “full submission”, and next steps toward review.

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Study Contacts

Submission Date:

February 17 2022 14:22:48

Study Proposal

"Amgen Product" identifies Amgen product most likely related to study (including where drug support is not being requested, i.e., Observational studies).

Country Information
Treatment Line
Will this study require approval (IND/CTA) from your Regulatory Authority?
Study phase:
Study Design:
Site Information
Study Objectives
Study Endpoints
Estimated duration of research (First Subject Enrolled to Final Study Report and/or Draft Manuscript):

Treatment Arms, Schedules and Duration

If Amgen product is being requested in support of this study, then the study drug will be provided directly to the Sponsor or 3rd party vendor as Commercially-labeled drug supply and may require clinical trial labeling and/or additional stickering (e.g. ‘For clinical trial use only’) by the study Sponsor. Exceptions to this include studies that are blinded, or if the study drug in question is not Commercially available in which case Clinical Supply will be provided and labeled by Amgen.

Investigational arm:

Comparator arm:

Home Use:

Does the Sponsor have the capability to label and/or sticker drug and create/maintain study blind or contract with a vendor to perform these activities (if needed) for those being provisioned with commercial supply?*

*additional costs for labeling/distribution and/or vendor costs should be added to study budget if applicable

Subject Selection

Support Requested

Support Requested?
If requesting drug, are you familiar with and able to perform the drug storage and administration requirements for the product(s) you are requesting?
If requesting drug, is your site equipped to destroy drug?
Is support being requested from other entities?
Support requested from other entities?

Additional Information About Your Proposal

The text limit is 5,000 characters.

Attachments


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      Clinical Submission Form For ISS
      NonClinical Form
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      • Multiple sessions are allowed to complete the submission
      • We recommend you complete the form within 30 minutes
        • The session will timeout in one hour from login
      • Please have the following information available:
        • Contact Information for Amgen Global Medical Representative with whom the proposal was discussed
        • Study Proposal
        • Study Design
        • Support Requested