TO:             ALL PRINCIPAL INVESTIGATORS/NURSES/DATA MANAGERS 

FROM:       REGULATORY AFFAIRS DEPARTMENT 

DATE:        August 14, 2019 

RE:             PROTOCOL NRG-GY018 – KIT ORDERING

 

Protocol Title:  “A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer” NCI Version Date: 07/03/2019

Study Chair:  Ramez Eskander, M.D., (858) 822-6199; email: reskander@ucsd.edu

 

Please be advised that there is approximately a 10-day turnaround time to receive a kit from the day a kit is requested.  There is no ability to expedite a kit shipment.  Please consent your patients accordingly.   

As a reminder, kits cannot be ordered until a site has completed the following study requirements:

  • IRB Approval
  • Delegation Task Log (DLT) approval
  • NRG-GY018 Certificate of Review for Protocol Training for all staff listed on DTL
  • Signed Pharmacy Agreement

CTSU will notify the NRG Oncology Regulatory Department when a site has met all the requirements.  Approvals are processed by NRG Oncology Regulatory staff and access to the kit ordering software will be granted 24-48 hours after your site has satisfied the requirements.

 

 

 

 

 

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