Study Management/Progress

The investigator may begin the II-SR study after a Study Agreement has been fully executed by all of the relevant parties.

Study Start-up

Funding (if applicable): Upon receipt of a fully executed Study Agreement and completion of previously stated requirements, Takeda will initiate the first payment invoice to generate the initial milestone payment.

Clinical/Drug supplies (if applicable): Upon receipt of a fully executed Study Agreement and dates for IRB/IACUC and/or IND approval (if applicable) dates entered into the Takeda II-SR website and performance of any other tasks required by the terms of the Study Agreement, Takeda will generate the first shipment of clinical supplies to the site.

Study Maintenance

Enrollment/Progress Update: The investigator must provide Takeda with a monthly update on the progress, including serious adverse events (SAEs)* of the study by the first (1st) day of each month. The investigator must notify Takeda of the status of subject enrollment and study progress by entering the appropriate information in the Takeda website. In the case of studies that do not involve human subjects, the investigator must update Takeda, via the website, on the status of pre-clinical or database analysis.

* The Study Agreement sets forth the obligations of the Institution, Investigator and Takeda in relation to serious adverse event reporting for the study.

Whether the serious adverse event is considered a clinical or post-marketing event, Takeda requires that all information be communicated to Takeda's Pharmacovigilance Department at takedasafety@tgrd.com, Fax Number 1-224-554-1052 or Phone Number 1-866-723-9473. The investigator is also required to indicate the SAE in the monthly updates on the II-SR website.

Additional information on reporting SAEs to the FDA may be found at: http://www.fda.gov/medwatch/REPORT/mfg.htm

If a study has failed to enroll any patients for two (2) consecutive months or provide an update on the status of an ongoing project, the investigator will receive a reminder letter from Takeda. The reminder letter will state, generally, that the study's projected enrollment has fallen behind and that Takeda may discontinue support for the study if enrollment does not meet the projected monthly enrollment for the next three (3) consecutive months.

Takeda will re-evaluate the study's enrollment or progress three (3) months following the date of the reminder letter.

Additional Clinical Supplies: After the appropriate enrollment milestone is met, the investigator submits a drug request via the II-SR website to initiate the next drug shipment (Please allow five (5) business days for shipment preparation).

The principal investigator is responsible for tracking receipt, dispensation, and destruction and/or return of clinical supplies.

Invoices: Takeda requires the investigator to submit a payment request via the Takeda II-SR website prior to Takeda making any payments. An investigator may track a study's payment history via the Takeda II-SR website to determine current status of payments.