Initiating Studies

Requirements

• IRB approval and dated final stamped consent form
• Copy of final protocol
• Copy of investigator brochure
• Copy of latest patient history and physical exam results
• Emergency contact numbers for study coordinator, principal investigator, and covering physician's phone, beeper, and cell numbers
• Signed and dated budget between CRC and Investigator

Please contact Nancy Olesinski, our Patient Scheduler, at (732) 418-8470, before 11:30 am on Wednesday for services requested for the up-coming week.

Budgets

• Budgets will vary by study depending on services requested for each specific protocol.
• Budgets are prepared based on nursing time needed, lab processing, study specific procedures, as well as a facility fee depending upon the length of stay.
• We can provide preliminary budgets, based upon a study synopsis or a draft protocol, in order to provide you with initial information for your budget requests to sponsors.
• We can also provide assistance for preparation/negotiation of budgets to study sponsors.

Please contact Sherri Gzemski at (732) 418-8481 for financial inquiries.

Institutional Reveiw Board

All studies that incorporate human subjects require Institutional Review Board (IRB) approval. For institutional investigator initiated studies the UMDNJ New Brunswick - Piscataway Campus IRB provides review services. For industry sponsored studies the Western IRB, a commercial IRB located in Olympia, WA, has been contracted to act as one of UMDNJ's IRBs to review and monitor industry-sponsored clinical research studies. All investigators are required to complete the CITI Basic Course training course. For further details regarding an overview of the IRB process, training, standard operating procedures, and forms necessary for IRB submissions please see the UMDNJ New Brunswick – Piscataway Campus IRB web page.

For information on the Western IRB, Click Here.