Grants - Investigator Initiated Studies

INVESTIGATOR INITIATED STUDIES (IIS) GRANTS PROGRAM

Through our IIS Grants Program, Tris Pharma is committed to supporting the advancement of scientific knowledge, improved patient outcomes and the quality of healthcare through original, diverse, investigator-initiated proposals. We invite you to submit your proposal for support. Please consider submitting your request in English. Submission in languages other than English will require translation and may result in an extended period of time for review and consideration.

Eligibility:

Grant-eligible research may be pre-clinical, post-mortem, in vitro, and/or human clinical in the areas of vascular access, anesthesia, emergency medicine, cardiac care, interventional access, urology, and surgical.

Note of disclosure:

As of January 2012, U.S. Federal law requires that companies collect information relating to payments and transfers of value and submit this information to the government for publication on the CMS Open Payments website. Tris Pharma complies with this law.

Requirements / Responsibilities:
Investigators must:

Be qualified by training and experience to lead the proposed research
Not be excluded, debarred, suspended, or otherwise ineligible to participate in health-care programs
Not be an employee of Tris Pharma
Be the originator of the research idea and author the concept/protocol

The Investigator is responsible for conducting the study in accordance with the protocol (developed by the Investigator), applicable institution policies, generally accepted standards of Good Clinical Practice (GCP)/Good Laboratory Practice (GLP), and all applicable laws and regulations governing the performance of the study.

Review of the IIS Grant Request depends on the completion of the IIS Grant Request Form and submission of the documentation listed below. Missed information may delay the review process.

A current copy of your Curriculum Vitae (CV)
Research proposal (includes research hypothesis, proposed study design,

inclusion/exclusioncriteria, and recruitment plan)

Documentation of the support requested, including:
- Detailed budget (if requesting funding)
- Type and amount of product (when applicable)

IIS Grant Request Form
»

Approval / Acceptance:

All proposals will be reviewed based on scientific merit and available funding. Once a proposal is endorsed, Tris Pharma will request review of the final approved protocol to ensure it accurately reflects the endorsed proposal. This final approved protocol will be a part of the agreement between the research institution and Tris Pharma. Unfortunately, not all proposals will be endorsed. Tris Pharma will notify you of our decision as soon as possible after the review of the submission.

Summary of IIS Process:

	Sponsor-Investigator	Tris Medical
Application & Review	Submit summary of concept or full protocol, including required initial documentation and information	Review submission Request additional information, as needed Communicate final decision to support or decline the submission Inform approved applicants of next steps
Grant	Submit final required documentation and information	Review all submitted final documents Negotiate, finalize, and execute agreement
Grant	Activation	Issue initial payment/shipment per agreement
Study Conduct	Research	Monitor progress
	Data reporting	Review submitted final study report. A quality draft manuscript may be used as the final deliverable, per study agreement
	Final reconciliation	Determine if any excess support should be returned to Tris Medical and notify Investigator

Your support in the advancement
of scientific knowledge to improve patient outcomes

INVESTIGATOR INITIATED STUDIES (IIS) GRANTS PROGRAM