Purpose of IIR Informational Guide

Welcome! TAP Pharmaceutical Products Inc. (TAP) is pleased that you are interested in conducting an Investigator Initiated Research (IIR) study. TAP has created this Informational Guide to assist investigators in working with TAP throughout the entire IIR process.

The TAP IIR Informational Guide is also available online. Go to www.tap.com , click on Research & Development, then click on Investigator Initiated Research.

 

What is Investigator Initiated Research (IIR)?

Investigator initiated research (IIR) is defined by TAP as unsolicited pre/non-clinical, clinical, health economic and outcomes research (HEOR), or systematic article review research studies related to a TAP compound or TAP supported therapeutic area in which an investigator, or the institution with which the investigator is affiliated, serves as the Sponsor and owner of the data and for which TAP provides support. The investigator is responsible for initiating and conducting the study, and directing the administration or dispensing of study drug (if applicable). In addition, the investigator must comply with all applicable federal, state and local regulations related to conducting research.

TAP will support IIR studies involving a TAP drug or therapeutic area of interest by providing funding and/or drug to the investigator.

IIR is also known in the pharmaceutical industry as Investigator Initiated Studies (or “IIS”) and Investigator Initiated Trials (or “IIT”).

 

Definitions

Sponsor : An entity who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

Investigator - An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject).

Investigator-Initiated Research : Unsolicited pre/non-clinical, clinical, HEOR, or systematic review research studies related to a TAP compound or TAP-supported therapeutic area in which an investigator, or the institution with which the investigator is affiliated, serves as the Sponsor and owner of the data and for which TAP provides support

Medical Education and Research Liaison (MERL) - TAP R&D field based medical and research liaison team member who conducts scientific exchange with academic and clinical experts in therapeutic areas of interest to TAP. The MERL team will serve as an educational and research resource for investigators and serve as the investigator's liaison with the TAP home office.

 

Why Does TAP Support IIR?

TAP's objective in supporting an unsolicited investigator initiated research pre-clinical, clinical, (HEOR), and systematic article review research studies is to obtain valuable scientific, clinical, and outcomes information relating to TAP products or disease states of interest and to enhance patient care. TAP may support legitimate programs in a manner consistent with all applicable regulatory requirements and ethical standards.

TAP envisions its IIR program to be comprised of the following:

• Establish robust scientific research that helps TAP to answer pertinent questions about its products and therapeutic areas of focus.
• Ensure activities conducted using an efficient and systematic process that is understandable and easy to execute by all involved.
• Collaborated with Investigators to conduct studies and are accountable for meeting agreed upon goals and working toward the end result of manuscript development.

The mission of TAP's IIR program is to:

• Foster scientific exchange through clinical research collaborations by
• Uncovering emerging research trends and fulfill unmet needs for new scientific data to help advance knowledge of a specified therapeutic area; and
• Exploring feasibility and viability of new scientific ideas of interest (often pilot/hypothesis-generating studies);
• Enhance basic/clinical science, health economics knowledge, and scientific education through publications; and
• Enhance patient care through research, publications and education.

 

TAP IIR Website

TAP provides an online system for the management of IIR projects. This system enables investigators to view real-time information related to their particular IIR study including:

• Completing new concept and new protocol submissions;
• Receiving real time responses to the above submissions;
• Tracking study enrollment;
• Monitoring payment history;
• Managing clinical supplies; and
• Closing out the study.

To access TAP's IIR system, an Investigator must register for a user ID and password through TAP's website www.iir-tap.com .

The TAP IIR Program is comprised of five steps:

• New Concept Submission (NCS);
• New Protocol Submission (NPS);
• Acceptable Protocol Submission (APS);
• Study Management; and
• Study Close-out.

An investigator's access to each area of the system is granted throughout the study's duration, on a step-by-step basis. For example, once an Investigator has completed the New Concept Submission, TAP will grant the Investigator access to the New Protocol Submission area. The Investigator is notified via email each time TAP receives documentation from the investigator.