Study Management

Study Start-Up

The IST Recipient may begin the Study after the Grant Agreement has been fully executed and all applicable approvals (e.g., IRB/IACUC approval, IND) have been secured.

The Grant Agreement will set forth the timing for payment of the first milestone payment, as well as provision of Study Drug.  The IST Recipient must initiate the payment and/or drug shipment via the IST System.

Study Progress

The IST Recipient is required to provide EMD Serono with a Monthly Status Report on the progress of the Study.  Monthly Status Reports for all IST Recipients are due the first business day of the month. 

If an IST Recipient fails to submit a Monthly Status Report, no further milestone payments and/or drug shipments will be made until the Monthly Status Report is submitted.  Failure to submit the Monthly Status Report will be escalated to the Review Committee to determine the appropriate action.

Studies that fail to progress as outlined in the IST Proposal will be brought to the attention of the Review Committee to determine the appropriate action.

Milestone Payments: Once a milestone event has occurred, the IST Recipient may submit a request for payment via the IST  System.  The IST Recipient may track a Study’s payment history via the IST System.

Drug: Study Drug shipment requests must be made via the IST System.

Please note: A current Study IRB/IACUC approval (and, if applicable, IND approval) must be on file in order for milestone payments and/or drug shipments to be processed.

Amendment Requests

As a study progresses, an IST Recipient may see a need to amend some aspect of the Study.  All requests for an amendment must be made via the IST System.  Amendment requests cannot be made via email or via the telephone.  Amendment Requests may include a change in budget, change of institution, request for additional Study Drug, extension of the Study timeline, or modification of the protocol.  All Amendment Requests must be reviewed by the Review Committee.  The IST Coordinator cannot approve an Amendment Request.  The IST Recipient will receive an email notification with the Committee’s decision.

 

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