All Human Subject Initial Expedited Projects to be Submitted in Ideate Beginning 5/31/16

The Program for the Protection of Human Subjects (PPHS) is moving forward in its roll-out of the IDEATE electronic submission process. Currently all Exempt projects are being reviewed through IDEATE, and starting Tuesday, May 31, 2016, all Initial Expedited applications from all departments must use IDEATE.

Research Administration has been working for many months on this new electronic submission process using a program called IDEATE, which will be used when applying for human research project approval.  At this time IACUC and some IRB submissions are reviewed using the software, and the plan is for the submission program to serve all research administration offices (i.e. PPHS, IDS, RSC, IBC, CRU, etc.) and allow all of the research offices to electronically review a single application! This will be a marked improvement over the current state where multiple different submissions may have to be made for a single project.

There is no required training, but the PPHS encourages you to connect with the IDEATE@mssm.edu team for assistance.  Remember that an IF submission must first be created through Sinai Central, all education requirements must be met for everyone on the team, and an InfoEd submission started by the research team before a submission will be accepted by the PPHS.  The PPHS also suggests that your researchers register with IDEATE for access to the system and ask that they update their profiles (adding their CV) before they begin their first submission. 

Please follow the helpful links below for assistance.

IMPORTANT NOTE: Currently, only Firefox browser is supported for IDEATE at this time: Download Firefox

We encourage your feedback over the next several months, as we make this system robust and fix the emerging issues.  Thank you in advance for your attention to this very important project.

 

E-Prescribing Study Medications to the Investigational Drug Service

The Investigational Drug Service (IDS) has implemented e-prescribing for clinical trials. Investigators may electronically prescribe ambulatory medications for outpatient trials to the Investigational Drug Service at Mount Sinai Hospital. There are several advantages to this system. For example, medication orders are linked to GCO numbers in order to avoid protocol deviations. In addition, study-specific templates may be pre-built for the user’s convenience to be updated at the time the order is placed. Please note, if a researcher is e-prescribing controlled substances, they will need to go through an enrollment process to gain the appropriate level of permission to proceed, which can be arranged via their designated department’s enrollment supervisor.

When e-prescribing for research, please take note of the following:

  • Enter the GCO number of the study (GCO#xx-xxxx) into the medication field.
  • Indicate the date due after the directions for use.
  • Refills are NOT authorized for investigational agents.
  • Select Mount Sinai Hospital Pharmacy (ID#74819) by searching “IDS” or “Investigational” or “Mount Sinai” or “Mount Sinai Research.”

This new process has been put into place in anticipation of the New York State’s mandate effective March 27, 2016. Although these regulations do not apply to investigational medications, Mount Sinai Hospital wanted to offer the service to the research community.

For more information about e-prescribing within the Mount Sinai Health System, visit the EPCS Intranet, email the project team: EPCSquestions@mountsinai.org, or contact the IDS at 212-241-2437.

If you have further questions about the e-prescribing mandate, please contact the NY State Bureau of Narcotic Enforcement. Contact information can be found online.