Task/Methodology

Deliverables

Time Period Due

New Concept:

1. Write New Concept; enter via website
2. Prepare/update Curriculum Vitae (CV); enter into website

1. New concept
2. CV

Anytime

New Protocol:

1. Complete New Protocol Submission Form via website
2. Complete Resource(s) Request Template(s)
3. Determine supporting documentation

1. New protocol
2. Completed Resource Request
3. Listing of support documents

Within 3-6 months from New Concept Acceptable or Conditionally Acceptable decision

Fair Market Value:

Acceptance of documented industry fair market value for services

Fair market value negotiated budget

Prior to Study Agreement initiation

Study Agreement :

Review of draft Study Agreement, redline any requested changes, and approve final Study Agreement

Executed Study Agreement

Within 3 months from New Protocol acceptability

Regulatory Documents: (if required)

1. Submit IND or request IND exemption (if required)
2. Obtain IRB approval

1. Date of FDA Letter of Receipt for IND (if required)

2. IRB approval date

Within 4 months from New Protocol acceptability

Clinical Registry (if required):

Register clinical trial on ClinicalTrials.gov

Checkbox completed in IIR database system

Prior to initial milestone payment or shipment of drug

Enrollment:**

1. Enter enrollment status by the 5 th of each month into TAP IIR database system by 1 st of each month
2. Complete enrollment on time as projected in original Study Agreement

1. No. of subjects enrolled, dropped, completed into TAP website iir-tap.com
2. Subject enrollment as projected

1. First day of each month
2. Per Study Agreement

Invoicing :

Submit appropriate payment requests through the TAP website iir-tap.com

Payment request

Upon completion of each milestone per the Study Agreement

Drug/Clinical Supply Accountability:

1. Determination of supplies needed, delivery dates, tracking of supplies
2. Determination of either return or destruction of supplies

1. Completed Resource Request – Drug
2. Confirmation of destruction or return of unused supplies in TAP IIR database

1. Upon New Protocol acceptability
2. Prior to final invoice payment

Close-out of Study:

1. Completion of study per timeline in Study Agreement
2. Prepare final documents (abstracts, presentations, manuscripts, study reports, etc) via Microsoft Word

1. Completed study
2. Submission of final document(s) for TAP courtesy review via TAP website iir-tap.com

1. Prior to expiration of Study Agreement
2. Prior to publication/sub-mission as set forth in Study Agreement