What should I send to OCT first?

Please send your agreement to OCT as soon as possible. If you have an electronic version, please send that to oct@unc.edu. Keep in mind that all agreements must be accompanied by a Review Request Form (RRF). OCT requires that a hard copy be sent since the RRF asks questions related to publication and intellectual property rights which requires original PI signature.

Why do I need to send a Review Request Form (RRF) every time I send something to OCT?

The RRF contains important identifying information including sponsor and department contact information. Many principal investigators have agreements with the same sponsor. The RRF is used to correctly identify the agreements and to ensure that all of our information for the agreement is correct. It may be helpful to copy the original RRF for future use instead of creating a new one each time you send an agreement to OCT.

There have been many different versions of the RRF. How do I know which is the most recent?

We have revised the RRF several times, taking into account suggestions from coordinators, principal investigators, and administrators so that the form can evolve into a version that suits everyone’s needs. Since the RRF has changed in the past and is likely to continue changing, please use the RRF posted on the website each time you submit. The RRF has a version and a version date in the lower right hand corner so you can be sure you are using the most recent version.

I am sending in a confidentiality disclosure agreement (CDA). I don’t know all the information that is requested on the RRF. How should I fill it out?

First, the RRF asks for the type of agreement that you are submitting at the top of the form. Indicate that it is a CDA here. Secondly, complete as much information as you can. You may not know the protocol name or number but you will have contact information for the sponsor/CRO. Since you won’t be able to answer the questions at the bottom of the form, just strike through them and write “N/A” (instructions for completing the form).

How long will it take to complete an agreement?

There is no set answer. Many factors contribute to the time involved in negotiating the contract such as responsiveness of the sponsor, type of agreement, whether the principal investigator initiated the study and if we have a master agreement with the sponsor.

How can I check on the status of the agreement?

There is a status request form on our website. It asks for basic identifying information. Status requests are generally answered within one business day. You can also call our office at 843-2698 or send an email to oct@unc.edu. Be sure to include the sponsor, PI, and protocol number when inquiring.

My P.I. has signed the agreement. Can you pick it up?

No. Due to lack of staff, OCT is unable to provide a courier service to campus. We recommend that you deliver the agreements to our office located on Elliott Road next to the State Employees Credit Union in the old Public Gas Building. We do not recommend that you send signed, original agreements via campus mail since there is a chance they could get lost.

Why do I have to submit a proposal packet before my contract can be signed?

The state gathers information about all research conducted at UNC so certain forms are required. A complete proposal packet includes:

  • Internal Processing Form (use electronic form)
  • IRB letter
  • Internal budget
  • Contract with final budget
  • Informed Consent Form
  • Protocol

If your trial requires review from other committees (i.e. Radioactive Materials, Potential Biological Hazards), you must submit those committee review letters also.

Remember to send the original packet plus 2 copies. The University will keep a copy of the proposal packet, the protocol and informed consent form, and an original copy of the fully executed clinical trial agreement on record. Remember to send the original packet plus 2 copies.

What do you look for on the internal budget?

The internal budget must show salary support for the PI and research personnel, the IRB fee (if applicable) which is not subject to the F&A rate, and that the correct F&A rate is applied to all costs except the IRB fee. Remember that the final number in the internal budget must match the final amount in the contract. Therefore, always include a copy of the sponsor’s final budget.

What do I need to do to get an account number for my clinical trial?

OCT does not set up accounts. Before an account number can be assigned, the university must have on file a copy of the proposal packet, the protocol and informed consent form, and an original copy of the fully executed clinical trial agreement on record. OCT gathers this information and forwards it to the Office of Sponsored Research who is responsible for establishing accounts.

My sponsor has sent me a check for the first payment and it includes the IRB fee. What do I do?

Send the check to the Office of Sponsored Research as usual. Include a memo stating that $2,000 is for the IRB fee.

My study is a retrospective chart review that involves gathering data about the outcomes of a certain disease and its various treatments. Is this considered a clinical trial?

No, this study would be considered a research study, not a clinical trial, for the following reasons:

  • It is retrospective in design.
  • The data already exist.
  • No interaction with a human is required in order to gather the data.

This study would be processed through the Office of Sponsored Research and will be assigned the full F&A rate.

Does OCT have a template contract to send to sponsors?

Yes, UNC does have a template agreement that can be made available to sponsors. Sponsors can view the template but OCT would prefer to be notified if the company would like to make changes. Questions regarding this template or any proposed template deviations should be directed to the Office of Clinical Trials at 919-843-2698 or via email to oct@unc.edu. Sponsors can request an electronic version of the template by emailing their request to oct@unc.edu.

What is a 98 account number and how do I obtain one?

A 98 account number is used by the hospital to bill clinical-trial-associated costs to the investigator. By using a 98 account, subjects will not be billed for the tests they undergo as part of the protocol. For example, charges incurred through the use of the GCRC, ECG services, lab tests and other hospital services will be billed to this account. An invoice will be sent to the investigator for payment. Your department administrator will pay this bill with the funds received from the sponsor. Each trial should have its own 98 account number. You may obtain one by contacting Amelia Rountree at 966-1234.

Where can I get dry ice?

  • University Scientific Supply
  • 843-6857
  • Available for delivery Mondays and Thursdays
  • Available in block or pellet form, in a box 12″x12″

Ice chests can be purchased from Fisher Scientific as “Polyform Portable Containers” or “Polyform Insulated Storage Chests”. Some are styrofoam boxes, but plastic boxes are also available. The 50 lb styrofoam box (Cat. No. 11-676-10) works well because the entire pellet box fits perfectly into the styrofoam box, thus providing better insulation and helping to make one box last all week. To request a catalogue, call 800-766-7000 or contact the local on-campus representative (Ernie) at 843-5604. He can set up online ordering.