The Office of
1109-A Bioinformatics Bldg.
130 Mason Farm Rd.
CB 1651
Chapel Hill, NC 27599-1651
919-843-2698 ph
919-843-2399 fax
Whether you are submitting a CDA, a CTA, or an amendment to OCT, a complete and legible Review Request form is required with every submission. The Review Request form includes all information vital to the trial including important contact information. Documents will not be processed with out this form. You may fax or send a hard copy to OCT only since this form requires signatures.
Tip: Keep the original Review Request form and include it with every document you send to OCT.
The CTA contains a termination clause. If the sponsor discontinues a trial for any reason, fax or send a hard copy of the sponsor correspondence to OCT with the required Review Request form. Conversely, if the P.I. decides to cancel the trial, please notify OCT as soon as possible.
A Confidentiality Disclosure Agreement is an agreement between the sponsor and the university which allows the sponsor to provide a protocol to the investigator. The agreement is intended to maintain confidentiality of the protocol and related information. A CDA may have other names such as a non-disclosure agreement, a secrecy agreement, etc. Once a sponsor or Contract Research Organization (CRO) has identified UNC as a potential site for a clinical trial, a CDA may be sent to the principal investigator (P.I.) or directly to OCT (please note: not all sponsors require a CDA). In an effort to protect the University and the investigator from potential liability, this agreement must be reviewed and/or negotiated and approved by OCT. While CDA's are usually straightforward and require little change, some can include requests that UNC cannot honor. For example, as a state institution, the University cannot subject itself to the laws of other states. If the P.I. signs the CDA without University review and signature, the P.I. will incur sole responsibility and the University will be unable to support him or her in the event that the terms of the CDA are breached.
When a department receives a CDA, send it immediately to OCT along with the appropriate Review Request form. You can email an electronic copy or fax a copy to OCT. You will receive a confirmation of receipt from OCT by email in return. This will acknowledge that your document was received and will identify the OCT tracking number it was assigned. Please note the OCT tracking number, as you will be able to use this number to track the progress of your agreement. If you do not receive a confirmation of receipt, please call the OCT at 843-2698.
Once the terms of the CDA have been negotiated, OCT will send 2 original CDA's to the P.I. for signature on each. Once signed, return both copies to OCT for University signature. The OCT will send both originals of the CDA to the sponsor. Once OCT receives a fully executed CDA, a copy will be sent to the P.I. for your files.
Please feel free to call or email OCT to check on the progress of the CDA. Please include the P.I., sponsor, protocol including protocol number, and OCT tracking number.
The next step is the clinical trial agreement. The Clinical Trial Agreement is an agreement between the sponsor and the university to define the scope of work required by the protocol.The CTA may have other names such as letter of agreement, clinical research agreement, statement of work, etc. The OCT negotiates the CTA with the sponsor. However, the P.I. will be responsible for finalizing a budget with the sponsor. Please see "Budgets" for more information.
Master Agreements are agreements that embody agreed-upon terms and conditions of a basic relationship between UNC-CH and a sponsor. Items covered in a Master Agreement include publication, confidentiality, intellectual property, indemnification, publicity, notice and access to information, to name a few. These terms and conditions will govern each study done, regardless of Principal Investigator.
Once a Master Agreement is in place, an "addendum" or "study letter" is generated for each new study to be done under this Master Agreement. The Addendum sets forth the items particular to a certain study such as dollar amount, protocol name, and principal investigator. These Addenda are "attached" to the Master Agreement. This alleviates the need to "reinvent the wheel" for each agreement; the major terms are agreed upon and only the particulars need to be negotiated.
We currently have several Master Agreements in place and we are currently working on several more. The sponsors with whom we currently maintain Master Agreements are:
The university has a template agreement that sponsors may use for purposes of conducting a clinical trial with UNC-Chapel Hill. You may refer sponsors to the template agreement in the sponsor section of the website. Please do not change or insert any information into the template agreement. Sponsors may contact OCT at 919-843-2698 or email oct@unc.edu to request an electronic version of the template agreement.
Please email an electronic copy or fax or a copy of the contract to OCT as soon as you receive the CTA. This will allow us to begin the negotiation process with the sponsor immediately. A Review Request form is required to begin the process. Please pay close attention to the questions on the Review Request form regarding publication and intellectual property. You will receive a confirmation of receipt from OCT by email in return. The time spent negotiating contracts varies greatly and often depends on the responsiveness of the sponsor. The OCT is committed to finalizing contracts as quickly as possible.
Once final agreement is reached and original final contracts are received from the sponsor, OCT will send 2 original CTAs to the P.I. for signature on each. Return both copies to OCT once it is signed.
Please see Retrospective Research and Data Registries for specific information regarding processing for these types of studies.
The University requires an approved proposal packet prior to signing a CTA. The OCT will then match up the contract with the proposal packet (see "Proposal Routing" for more information). Once the proposal packet is matched with the CTA, the University can sign the CTA. The OCT will forward a copy of the fully executed CTA to the P.I. once it is received from the sponsor.
Please feel free to call or email OCT to check on the progress of the CTA. Please include the P.I., sponsor, protocol including protocol number, and OCT tracking number.
If for any reason, the trial is cancelled or the P.I. has decided not to proceed with the trial, please contact OCT.
The University must review all proposal packets to make sure everything is in compliance with University requirements for clinical trials. This includes such things as ensuring that the IRB has reviewed the protocol, the requirement for certification for investigators involved in human subjects research has been met, and that the budget includes the appropriate facilities and administrative F&A (formerly called "indirect") costs. F&A costs will be discussed further in "Budgets".
All research conducted at UNC-Chapel Hill requires prior institutional approval that is independent of IRB review/approval. Two offices are involved in the approval process: the Office of Sponsored Research (OSR) and the Office of Clinical Trials (OCT). The OCT will use the definition provided below to guide the flow of trials to the appropriate office. This definition is not meant to define what facilities and administrative (F&A) cost rate will apply to the research; however, it will guide us towards applying the appropriate rate.
The proposal packet is a packet of information containing the required University forms including the Internal Processing Form which is now available on line.
Print your completed forms and attach the following to complete your proposal packet:
The internal processing form must be signed by the following prior to submission to the OCT:
If investigators from different departments are involved, then the department chair from each department must sign the IPF. For example, if anesthesiology is doing a trial with orthopedics, both chairs must sign the IPF.
Please send the original packet along with a copy to the OCT. Only one copy of the protocol is needed. Extra protocols will be returned to the department. Due to the length of most proposal packets, the OCT cannot provide missing copies so please ensure that you have included it with your submission.
OCT will process your proposal packet with the IRB acknowledgment letter however, the Office of Sponsored Research will not set up your account until the IRB approval letter is received. In order to avoid delays and confusion, please fax or send a copy of the IRB approval letter to OCT as soon as you receive it.
Once your proposal is complete, please send the original packet to be used as the official university record, and a copy of the proposal packet minus the protocol for OCT file. Retain one copy for departmental files. OCT will return to the department a copy of the signed IPF stamped with the COEUS number and a copy of the fully executed agreement.
Research supported, through provision of funds or other consideration, by a sponsor external to the University that is designed to assess safety, efficacy and/or other outcomes of a drug, device, biologic, diagnostic, treatment or preventative measure in human subjects. Example:
Research studies that focus primarily on gathering data, such as retrospective chart reviews or studies that are gathering information for data registries, are not considered clinical trials. In order to begin to be considered a clinical trial, interaction with a human is required. Extracting data from a patient record is usually done without any interaction with the patient. Occasionally, such chart reviews may require a patient to sign an informed consent form. This is still considered a research study since you are not obtaining the information from an interaction with the patient — just the patient's medical record. Therefore, these studies will be assigned the full F&A rate and will be processed through the Office of Sponsored Research. Example:
Clinical Trial: The protocol requires a clinic visit every 3 weeks to obtain blood pressure readings from a patient over the course of 3 months. This is considered a clinical trial. It is prospective in design, requires interaction with the patient (taking the blood pressure reading) and may be conducted in a clinical setting.
Research Study: The protocol requires gathering blood pressure readings from the medical records of patients who were seen in the cardiology clinic over the past 3 months. Although the information comes from an interaction with a patient in a clinical setting, it is a retrospective study using pre-existing information with no direct interaction with the patient.
To determine if your study is a clinical trial or a research study, ask the following:
If you have questions regarding the type of trial your agreement pertains to, please contact OCT.
Submit the proposal packet to the Office of Sponsored Research as soon as possible to avoid delays. A finalized CTA is not required to begin the proposal packet review.
Download the Internal Budget spreadsheet for Clinical Trials [MS Excel].
All new contracts require the forms mentioned below. Amendments are handled differently. An amendment changes the terms of a previously executed agreement. If the amendment changes the dollar amount of the contract by either adding or subtracting dollars, you will need to complete an entire proposal packet. Please submit an internal budget that reflects only the increase explaining how the additional money will be spent. Do not add the increase to the original budget. The IPF should also reflect the increase only. If the amendment deals with other non-monetary issues ONLY such as extending the timeline of the study, a proposal packet is not required. Simply email and electronic copy or fax a copy of the amendment along with the required Review Request form to OCT. Please see this flowchart for further explanation.
Once the proposal has been approved, the contract is signed by the Univeristy. It is either partially executed which means it will be sent to the sponsor for their signature and returned to UNC, or it is fully executed which means that the sponsor has already signed it and it is complete once the PI and the University sign the agreement. An original of the agreement along with the complete, original proposal packet is sent to the Office of Sponsored Research which is designated as the official office of record for the documents. Before the Office of Sponsored Research can establish a University account, a fully executed CTA is required as well as a letter of IRB approval. If you have not received an account number, please ensure that a copy of the IRB approval letter was sent to the OCT.
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