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FAQs

How long will it take to get a new Trial Identification/Research Number?

The OCT promises a 24 hour turn-around period for assigning a Trial ID/Research numbers due to the large volume of daily requests.  To request a Trial ID/Research number please complete the Trial ID/Research # Request Form (Transmittal Form).  

 

Who is my Clinical Research Management Coordinator (CRMC)?

CRMCs are assigned by therapeutic area.  Please consult our latest version of the Project Management Portfolio for a complete listing.  

 

How do I expedite the review of my Industry Sponsored trial?

Contact the appropriate Clinical Research Management Coordinator (CRMC) to ascertain the status of a study.  The CRMC will e-mail an update within two business days.  In addition you can check status via webaccess to InfoEd Clinical Trials Management Systems (CTMS).  If you reqquire training and/or access please complete the CTMS Training Request Form and forward to INFOED-SUPPORT@med.nyu.edu.

 

How do I know what office needs to review my contract, or where my contract is?

The source of funding or service, and type of service involved, currently determines which office must review a contract.  If the contract involves funding from a foundation or government agency, it should be reviewed by Sponsored Programs Administration (SPA).  If the contract is between NYUMCs School of Medicine and an industry sponsor, and is not for a clinical trial, it will be reviewed by Office of Industrial Liason (OIL).  OIL also negotiates Material Transfer Agreements (MTA), which are for the transfer of material (e.g.- laboratory mice, tissue samples, cell lines, between one institution to another).  If the contract is between NYUMCs School of Medicine and an industry sponsor and is for a clinical trial , it will be reviewed by the Office of Clinical Trials (OCT).  If your grant or foundation funded project contains human subjects the OCT is happy to assist in budget development.

For more information contact a Clinical Research Management Coordinator (CRMC) to ascertain the apprpriate office a contract should be sent. 

 

Why does it take so long to negotiate a contract?

Many policies for NYUMCs School of Medicine require compromise to meet with the overall purpose and mission of industry sponsors.  Depending on what issues remain in contention between both parties (i.e.- indemnification, publication, confidentiality, etc.) the duration of contract negotiations can be lengthy.  There is no set of right or wrong answers in contract negotiations, therefore the Contract Specialist negotiaties an agreement that is an acceptable compromise to both the School of Medicine and the Sponsor.  

 

How do I get a FAME Account?

When the OCT Financial Analysts receive a CTMS alert stating that the Clinical Trial Agreement (CTA) is fully executed a FAME account is created for that trial.  A FAME Account Notification is submitted to the Prinicpal Investigator, Department Administrator, and Research Coordinator providing the new account number where trial related revenues and expenses will be posted. 

 

How do I know if you have received payments for my study?

There are two ways to identify payments received on your study:

  1. A OCT Financial Analyst will notify your office when payments have been received.  A Payment Notification e-mail will be sent to all Principal Investigators, Research Coordinators and associated Financial Analysts for that department when checks are received for a particular study.
  2. By accessing e-Finance and entering the FAME account for your study, you are able to view all revenue and financial actiity for the pertinent account.

What is the waiver process for OCT Fees and Institutional overhead?

Please address a letter to Dr. Vivian Lee and submit the letter to the Clinical Research Management Coordinator (CRMC) assigned to your department requesting a waiver of the institutional fee(s).  In the letter, please inclued:

  1. The Trial ID number and Protocol title.
  2. Statement of the clinical and/or academic value of the study to the institution.
  3. The purpose of the waiver (example- no funding or lack of funding for trial).

Once submitted, the CRMC will contact you to review the waiver request letter and gather additional information.  In turn, the OCT will submit your request to the Vice Deans office on your behalf.