Frequently Asked Questions
What if I cannot remember my password?
You may request to have your password emailed to your registered email address by clicking on the appropriate links on the login page.
Why was I prevented from registering?
Common reasons include:
- Some of the information entered as part of your registration was not valid - please see the error message and re-enter corrected information.
- You entered an email address or username during your registration that has already been registered with the IST System. Please choose a different username or email address.
- If you have registered previously, please request that your password be emailed to you (see "What if I cannot remember my password?" above for details).
- If you have not registered previously, please contact the EMD Serono IST Coordinator at email@example.com.
Why was I unable to login?
Common reasons include:
- Your account may have been disabled due to inactivity. Please contact the EMD Serono IST Coordinator at firstname.lastname@example.org and request that your account be reactivated.
- Your account has been temporarily disabled due to repeated unsuccessful attempts to login. Please wait 30 minutes before you try to log in again.
What if I do not receive any e-mail notification about my application from the IST System?
Emails could be going to your Junk email folder.
Please perform the following actions:
- Check SPAM and/or Junk email folders – once located, right-click on the email and select the option under "Junk E-mail" to "Add Sender’s Domain to Safe Senders list."
- Alternatively, you can also manually add email@example.com to the safe senders list by taking these steps:
- Click on Actions, then locate the "Junk E-mail Options"
- Click on the tab for "Safe Senders"
- Click "Add", type in firstname.lastname@example.org, and click "OK"
Concept Overview and Proposal
What is the difference between a Concept Overview and a Proposal?
EMD Serono has a two step process for submitting Investigator Sponsored Trial applications. The first step is submission of 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 Proposal. The Proposal is a detailed application with a clear research hypothesis, proposed procedures, methods, research techniques, and potential outcomes. A Proposal may only be submitted if the Applicant receives a call back from the Review Committee.
Can I submit a Concept Overview that is outside EMD Serono's areas of interest?
As an independent Investigator, the decision on whether to submit a Concept Overview is entirely up to the Investigator. Preference will be given to Concept Overviews that are within EMD Serono's posted areas of interest. However, the Review Committee may consider a Concept Overview which is outside the areas of interest with the approval of the Chief Medical Officer.
What is a Request for Additional Information and how much time do I have for completion?
A Request for Additional Information is made when the Review Committee or IST Coordinator determines that more information is needed to process your application. The Request for Additional Information will be sent via email with the date the information is due. In general, if EMD Serono has not received all necessary information within 30 business days of the Request for Additional Information, the Concept Overview or Proposal will be closed and not given any further consideration.
Can I complete part of the online request and come back to it later?
Yes. If you are unable to complete your request in one sitting, you may save the request and come back to it later by clicking on the link at the bottom of the page. At any time before the submission of a request, you will have the opportunity to go back and make changes to the request.
When do I need to submit a study budget?
A budget should be included in your Concept Overview. You should ensure that all study related expenses (direct and indirect costs) have been included and are commensurate with fair market value.
What direct study costs can be included in the study budget?
- Subject-related costs or animal-related costs (as applicable).
- Study related personnel costs
- Diagnostic fees and services
- Data management expenses
What indirect study costs can be included in the study budget?
- Costs of reasonable travel, lodging, congress registration (if required to make a presentation) and related expenses of the Investigator for the express purpose of presenting the study results at one scientific congress or meeting can be included in the proposed study budget.
- Publication costs (e.g., medical writing to prepare a manuscript, manuscript submission fee) are limited to $2,500, absent special circumstances which must be documented.
- IRB fees which include the initial submission fee and all applicable renewal fees.
Are there any costs that can't be included in the study budget?
The following costs may not be included in any study budget:
- Start-up funds to establish a new clinical research program or expand an existing program.
- Purchase of capital equipment or software.
- Hiring staff not dedicated to the Study.
- Expenses related to business operations (e.g. electricity, phone, employee fringe benefits).
- Any permissible expense that exceeds fair market value.
- Upload a copy of your IRB/IACUC approval
- Upload a copy of your IND approval (if applicable)
- Submit requests for drug supply (if applicable)
- Submit milestone payment requests (if applicable)
- Submit Monthly Status Reports
- Submit copies of the Study publications
- Track the amount of milestone payments that have been paid
- Track how much study drug has been shipped
- Submit an Amendment Request
- Submit Final Study Report
After the Decision
What happens if my Concept Overview or Proposal is denied?
You will receive an email notification. All decisions by the Review Committee are final and there is no appeal process. You may, if you wish, submit another Concept Overview at a future date.
What happens if my Concept Overview receives a call back?
You will receive an email notification indicating your Concept Overview has been chosen for a call back and you will be given the opportunity to submit a Proposal. You will then have approximately 7 weeks from the date of notification to submit your Proposal.
What happens if my Proposal is approved?
You will receive an email notification indicating your Proposal has been approved for funding and/or research material. You will receive a Grant Agreement to sign.
What if I have my own Grant Agreement form from my institution?
All EMD Serono IST studies should use the Grant Agreement issued by EMD Serono.
What happens if I do not submit a Monthly Status Report?
If you do not submit a Monthly Status Report, EMD Serono will not make any further milestone payments or drug shipments until the report is received. Repeated failures to submit the Monthly Status Report will be escalated to the Review Committee to determine the appropriate action, including possible rescission of the grant.
What will happen if my study is not progressing according to the timelines in my grant agreement?
You should notify EMD Serono if your study is not progressing as expected and provide an explanation. You may ask for an extension of time by making an appropriate submission via the IST portal. Studies that fail to progress without a reasonable explanation will be brought to the attention of the Review Committee to determine the appropriate action, including a possible rescinding of the grant.
What is a milestone payment?
Milestone payments are the payment amounts agreed to in the Grant Agreement. Milestones payments are tied to certain events, such as patient enrollment, patient completion, data analysis, submission of a publication, etc. When a milestone event is reached, the IST Recipient may provide documentation that the milestone has been met and request the milestone payment be made through the IST System.
Can IST grant funds be made payable to individual investigators?
No, IST payments cannot be made to an individual. IST payments may only be made to institutions. All IST payments must be made to the Institution listed in the Grant Agreement.
What happens if I need to amend my approved study Proposal after the study has begun?
You must notify EMD Serono of any proposed amendment to the approved study Proposal after the study has begun and BEFORE the amendment is submitted to your IRB/IEC. To submit an amendment request, you will log into the IST portal and submit information on the proposed amendment. You will be notified of the Review Committee's decision.
What else can I use the IST System for?
Once an IST has been approved and the Grant Agreement has been executed, you will be able to enter, upload and access the following information related to your IST via the online system.
What will happen to the IST if the principal investigator changes institutions before the Study is complete?
Since ISTs are awarded to institutions, and not individual investigators, the institution that is the IST Recipient must submit an Amendment Request to have the IST transferred to another institution or principal investigator. The Amendment Request will be reviewed by the Review Committee.
Can I apply for an IST if I have already started my research study?
No, EMD Serono does not fund studies that have already begun.
Does previous support of IST studies by EMD Serono guarantee future support?
No, each IST request submitted to EMD Serono, will be evaluated based on its individual merit. An IST is not “approved” until written confirmation of approval and a Grant Agreement have been sent to an IST Recipient's institution.
Do I have to prescribe EMD Serono products to be eligible to receive an IST approval?
No, EMD Serono will make no grant as a reward or in exchange for prescribing or purchasing EMD Serono products or to induce the prescription or purchase of EMD Serono products in the future. Grant recipients are not expected or obliged to prescribe, purchase, or recommend an EMD Serono product.
Can an EMD Serono representative assist me with my submission?
No, EMD Serono representatives may NOT assist you in any respect with your submission. This means EMD Serono representatives may not help you come up with an idea for the study, design the study, write the protocol, review the protocol, write your application, review your application before submission, or otherwise be involved in the development of the study of your application. The Coordinator is available to assist you with the online application process and to answer any questions about the IST process and procedure.
At the conclusion of the study can my institution keep unused funds and/or study drug?
No, at the conclusion of the study you will be required to submit a budget reconciliation wherein you certify as to the amount of funds which have been used for your study. Your institution will be required to return any unused funds to EMD Serono. In addition any unused study drug will be returned to EMD Serono or destroyed as directed by EMD Serono.