Study Management

Once a Study Agreement for an IIR study has been fully executed by the parties, the Investigator may begin the study.

 

Study Start-up

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

Clinical supplies (if applicable) – Upon receipt of a fully executed Study Agreement and appropriate dates for IRB and/or IND approval (if applicable) dates entered into the TAP IIR database and performance of any other tasks required by the terms of the Study Agreement will generate the first shipment of clinical supplies to the site.

 

Study Maintenance

Enrollment – The Investigator must provide TAP with a monthly update on the progress of the study. By the fifth day of each month, the Investigator must notify TAP of the status of subject enrollment and study progress by entering the appropriate information in the TAP website iir-tap.com. In the case of studies not enrolling human subjects, the Investigator must update the TAP website iir-tap.com on the status of pre-clinical or database analysis.

If there is no patient enrollment for a 2 month period, the Investigator will receive a reminder letter from TAP. The reminder letter will state, generally, that the study's enrollment has fallen behind and that TAP may discontinue support for the study if enrollment does not meet the projected monthly enrollment for the next three months.

Three months following the date of the reminder letter, TAP will re-evaluate the progress of the study's enrollment.

If TAP determines that the study enrollment has not met the monthly enrollment projections for the three months following the reminder letter, TAP may terminate support of the study. TAP will notify the Investigator (and the related Institution), in writing, of its decision to terminate support of the study. This letter will also instruct the Investigator with respect to returning to TAP any payments (for services not performed) or clinical supplies that were not used in the study.

If TAP determines that the study enrollment has met the monthly enrollment projections for the three months after the reminder letter, TAP will notify the Investigator, in writing, that it has conducted its re-evaluation and determined that TAP support of the study will continue.

If TAP determines that the study enrollment falls behind again it will conduct a final study evaluation to determine whether the study will continue to receive support.

Additional Clinical supplies – After the appropriate enrollment milestone is met, the Investigator submits a drug request via study management on www.iir-tap.com to initiate the next drug shipment (please allow 5 business days for shipment preparation).

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

Invoices – for ongoing study payments and after the appropriate Study Agreement payment milestone is met TAP requires the Investigator to submit a payment request via study management within the TAP IIR website prior to making any payments. An Investigator may track a study's payment history on the TAP IIR website iir-tap.com.