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.