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MTPA IRP Process

Phase I: Submission of a Concept Overview
 In order to submit a Concept Overview, Applicants must first complete the registration and submit current curriculum vitae (CV). This may be done via the Mitsubishi Tanabe Pharma America (MTPA) online Independent Research Portal (IRP) application portal:
 Next, Applicants must fill out the Concept Overview page. The general information provided during the registration process will be used to pre-populate certain fields in the Concept Overview page. Applicants are required to provide the following information related to the proposed

Concept Overview:

  • Title of proposal
  • Type of support requested* (financial, drug or both) and an estimate of amount; include name of drug (if applicable)
    *Please note that MTPA shall support only finacial at this application period.
  • Study design
  • Study scientific rationale
  • Study hypothesis
  • Study population (Statistical plan/data analysis plan)
  • Feasibility of enrolling proposed population (study timelines)
  • Description of the unique or novel feature of the Study
  • Study Budget


All Concept Overviews must be submitted via the MTPA online IIT application portal. Hard copies will not be accepted.

Review and Approval of Concept Overview
Concept Overviews will be reviewed on a quarterly basis.
The MTPA Investigator Initiated Trials Review Committee (IIT-RC) will review all Concept Overviews for scientific merit, innovation, clinical importance/potential impact on patients, and compliance with company policy and requirements. The Review Committee will extend contingent approval* to certain Applicants to proceed to the second step of the process, which is submission of a detailed Proposal. Applicants will be notified of the Review Committee's decision via email and the status will also be available on the portal.

Phase II: Submission of Detailed Investigator Initiated Trial Proposal
Once Applicants have been granted contingent approval of the Concept Overview, Applicants may submit their Detailed Proposal. All Proposals must be submitted via the MTPA online IIT application portal within 6 weeks of approval of the Concept Overview. Hard copies will not be accepted. Proposals are reviewed on a monthly basis.

Study Budget
All expenses associated with conducting the IIT must be included in the detailed study budget of the IIT application. The expenses specified in the study budget must be aligned with the fair market value for similar expenses associated with similar research. Fair market value includes, among other things, consideration of the relevant market and geographic region. Expenses shall only be requested for research-related goods and services that are legitimate, reasonable and necessary in order to conduct the research and that are actually utilized in conducting the research. All payments must be milestone-based and cannot be conditioned upon final results and shall not be made in one lump sum prior to the start of research.

Permissible direct study costs include:

  • Subject-related costs.
  • Non-MTPA drugs and clinical supplies. For example, while MTPA does provide funding for placebo, it does not supply the placebo, nor does MTPA provide blinded study drug.
  • Study-related personnel costs (for personnel dedicated to the Study), but may not include the cost of any fringe benefits for the personnel.
  • Diagnostic fees and services.
  • Data management expenses.
  • Statistical services appropriately budgeted to the complexity of the IIT.
  • Institutional overhead - in general, the amount of institutional overhead is limited to 25% of the total research budget. An amount in excess of 25% may be approved by the IIT-RC, in its discretion, upon a factual showing of necessity.

Permissible indirect study costs may include:

  • •Publication costs (e.g., medical writing to prepare manuscript, manuscript submission fee, etc.) - this cost should be aligned with Fair Market Value (FMV), absent special circumstances which must be documented
  • Institutional Review Board (“IRB”) review fees - which may include initial IRB submission fee and all applicable renewal fees
  • Costs of reasonable travel, lodging, congress registration (if required to make presentation) and related expenses of the PI for the express purpose of presenting the study results at one scientific congress or meeting

Costs that shall not be included in any IIT Proposal include:

  • Start-up funds to establish new clinical research programs or to expand an existing program
  • Purchase of capital equipment or software
  • Hiring of staff that are not dedicated to the Study
  • Costs of travel, lodging, or related expenses of the PI for purposes other than presenting Study results at a scientific congress or meeting
  • Expenses relating to the PI normal business operations (e.g., electricity, phone, employee fringe benefits)
  • Any "permissible" expenses which exceed fair market value

Development of Full Proposal Documentations
The MTPA IIT-RC will review contingently approved proposal documentations including but not limited to full study protocol, budget and patient consent/assent (Informed Consent Form) if applicable with the 2 months of the contingent approval.

IIT Agreement
Applicants whose Proposal is contingently approved, will be sent an IIT Agreement which will set forth the obligations with respect to the study. Applicants will have four weeks from the date the Agreement is sent/emailed/uploaded to review, sign and return the Independent Research Agreement. If the IIT Agreement is not returned within four weeks, the contingent approval may be withdrawn.

Compliance
MTPA requires IIT(s) to comply with all applicable laws, rules, regulations and industry codes related to clinical and/or non-clinical research. IIT Recipient(s) may be required by law to file an IND for the Study. IIT Recipients are solely responsible for compliance with all applicable laws, rules, regulations and industry codes, including for example, making the IND determination and filing for the IND.
For those Studies that require IRB/IACUC approval and/or an IND, IIT Recipient(s) must submit a copy of the approved IRB/IACUC and/or IND via the MTPA IRP online portal.

Independent Research Recipient(s)
Non MTPA Study Drug
MTPA shall not support the drug cost of the standard of care and it is the responsibility of the IIT Recipient to maintain the Study Drug and supplies in the appropriate storage and handling conditions and to account for all Study Drug and supplies, including its receipt, usage, destruction or return.

Adverse Event Reporting
IIT Recipient(s) are responsible for complying with all applicable laws, rules, regulations and industry codes concerning adverse event reporting. The IIT Agreement will include information on how to submit an adverse event to MTPA.

Study Reports
In order to ensure the appropriate progress of research, MTPA requires that IIT Recipient(s) submit an update on the study on a monthly basis. Monthly status reports are due the first business day of each month. These monthly status reports must be submitted via the IRP online portal. Milestone payments will not be made if a monthly status report has not been submitted for the most recent month.
All Investigators must provide MTPA with a detailed Final Report which outlines the research findings.

Publications
MTPA expects the results of IITs to be published or presented, whether the results are positive or negative. “Publication” means any journal article, abstract, presentation, or other type of public disclosure that reports any Study Results. All publications must be sent to MTPA in advance of submission, according to the timeframe set forth in the IIT Agreement. All publications should comply with the authorship guidelines in the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (http://www.icmje.org/icmjerecommendations.pdf) established by the International Committee of Medical Journal Editors