Application Steps and Responsibilities

The IST application process has two steps.  First, you submit a Concept Overview, which is a brief high-level overview of your proposed Study.  EMD Serono will review all Concept Overviews and then extend call backs to some applicants to participate in the second step of the process, which is submission of a detailed Proposal.

There are several other steps in connection with the IST process.  EMD Serono has created the following table to give applicants an overview of some of their responsibilities in connection with EMD Serono’s IST Program.  Please review the following responsibilities carefully before applying for an IST.

Application Step

Responsibilities of Applicants/IST Recipients

Concept Overview

Concept Overviews may be submitted during the time periods when the system is open. Please refer to the IST Process Overview page for this information. All Concept Overviews must be submitted via the IST System.  No hard copy submissions will be accepted. 

Proposal

EMD Serono will extend call backs to some applicants to participate in the second step of the process, which is submission of a detailed Proposal. EMD Serono will evaluate all Proposals and then select a subset of them to receive funding.

Grant Agreement

Applicants selected to receive an IST (the “IST Recipient”) will have 8 weeks to sign and return the IST Grant Agreement.  If the signed Grant Agreement is not returned within 8 weeks, the Review Committee may rescind funding.

Approvals

  • IRB/IACUC approval
  • IND approval, if applicable

The IST Recipient must submit a copy of all applicable IRB/IACUC approvals via the IST System.  If applicable, a copy of the IND approval must also be submitted via the IST System.

Government regulations

IST Recipients must comply with all applicable federal, state and local laws, rules and regulations.  IST Recipients are “sponsors” of the studies, not EMD Serono. 

Monthly status report

IST Recipients must submit a detailed report on their ISTs to the Review Committee every month (“Monthly Status Report”).  The Monthly Status Reports must be submitted via the IST System. Monthly Status Reports are due the first business day of the month. If a Monthly Status Report is missed, funding will be suspended.

Milestone Payments

IST Recipients must submit a request for their milestone payments via the IST System.  They must identify the particular milestone which has been met when requesting payment.

Study Drug (if applicable)

IST Recipients must make all requests for Study Drug shipments via the IST System. The amount of Study Drug requested must not exceed the amount awarded in the Grant Agreement.

Adverse events

IST Recipients are responsible for complying with all applicable laws concerning reporting of adverse events and serious adverse events. 

Study Closeout

  • Final Report on Study
  • Study publication (a manuscript or abstract)
  • Certification
  • Budget Reconciliation

 

Upon completion or early termination of the Study, the IST Recipient must:

  • Submit a Final Report with Study results
  • Submit a publication (manuscript or abstract) on Study results to EMD Serono (must submit prior to publication or presentation)
  • Submit Certification Form (via IST System or as directed by the IST Coordinator)
    • If applicable, certify all funds used for Study, or return unused funds to EMD Serono
    • If applicable, certify all Study Drug used for Study or return any unused drug to EMD Serono
  • Submit a budget reconciliation; if applicable
  • Submit request for final milestone payment (this payment will only be made after submission of Final Report, Publication, Certification and Budget Reconciliation).

 

 

 

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