Study Close Out
When a Study is completed or is terminated early, the IST Recipient must submit: (1) a Final Report, (2) the proposed publication (manuscript or abstract), (3) Certification and (4) Budget Reconciliation (if applicable). All of these must be submitted via the IST System or as instructed by the IST Coordinator.
When a Study is completed or terminated, you must provide a certification which certifies that: (i) the Study was conducted in accordance with this Agreement, (ii) any unused Grant Funds and Research Materials have been returned to EMD Serono or destroyed as instructed, (iii) all safety reporting obligations were met, and (iv) a manuscript has been submitted to a peer-reviewed journal or an abstract has been submitted to a scientific or medical congress, or the Study was terminated early and a publication is not appropriate.
If a Certification is not provided, the final milestone payment will not be issued. In addition, the IST Recipient will be prevented from submitting any new IST Requests until the Certification is submitted.
Any unused IST funds must be promptly returned to:
EMD Serono, Inc.
Attn: IST Coordinator (list Therapeutic Area)
One Technology Place
Rockland, MA 02370
Unused drug must be returned to EMD Serono or destroyed as instructed by the IST Coordinator. IST Recipients should contact the IST Coordinator to obtain instructions and the shipping address to return unused drug.