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New Studies

All initial submissions of cancer-related studies (whether industry trials, investigator-initiated studies, studies sponsored by other institutions, cooperative group trials, etc.) should be submitted via ePRMS in OnCore. If the study team does not yet have access to ePRMS, please submit the materials directly to the PRC Coordinator at anly_thomas@med.unc.edu.

Please note: Studies are accepted in chronological order of submission. Agendas are capped at five initial/amendment reviews per meeting, with a submission cutoff of the date of the previous meeting (e.g., cutoff for January 30 meeting is January 16). Initial studies requesting a review at a meeting that has already met its limit will be required to outline all extenuating circumstances in a written rationale to be considered by the PRC Chair or Co-Chair.

Submissions to the IRB for studies which require PRC review must include the PRC approval letter. Once the PRC approval letter has been received by the study team, please include it with the rest of the initial IRB submission.

Submission information and requirements

The PRC reviews oncology studies from UNC investigators, including clinicians and research scientists, as well as cooperative groups, pharmaceutical companies and other institutions. Some of these studies will involve the use of the Clinical Trials Office (CTO), while some trials will use other resources. If you are not sure what you need, please contact the PRC Coordinator at anly_thomas@med.unc.edu for guidance.

Information Regarding RDRC Review for studies with radiopharmaceuticals

Please note: If your study utilizes radiopharmaceuticals to address basic science questions, an IND is not necessary. Instead, your study will be reviewed/approved by the Radioactive Drug Research Committee (RDRC). In this case approval by the Radiation Safety Subcommittee (RSS) is not required. For more information, please see the Radioactive Drug Research Committee website.

Required Documents for PRC Review

Please note: If your study references a separate DSM Charter (or other document that provides information regarding data and safety oversight), you MUST include this as one of your submission documents. This includes any separate documentation that outlines study monitoring and oversight, particularly if this is not clearly outlined in the protocol. Studies which do not provide clear evidence of DSM oversight and/or study monitoring will be deferred from PRC review.

1. PRC Submission Cover Sheet

Forms last updated March 2023

Any study which recruits from the UNC Health Care Clinical Settings for cancer patients must have sign off from the relevant Disease Group Leader (see table below). This sign off ensures that the Disease Group Leader responsible for the patient population you are approaching for your study is aware of the study, and has approved of you approaching their patients for inclusion in your trial. Additionally, this form provides an avenue for the Disease Group Leader to indicate if the trial will compete for resources with other existing trials, and how said trials may be prioritized in light of competing resources.

For studies recruiting from a specific patient population, please refer to the table below for appropriate Disease Group Leader to contact for signoff. For studies which involve multiple disease types or for disease types which are not listed below, please contact the PRC Coordinator at anly_thomas@med.unc.edu to determine the necessary signatures.

To obtain a signature, please ensure you forward your final protocol and the completed PRC cover sheet linked above to the appropriate Leader. Electronic signatures are perfectly acceptable.

  • As above, Industry Sponsors/Other Institution trials should include this document as one of the materials uploaded and submitted via IRBIS to ensure your submission is complete for PRC review.
  • All other trials should include this document, submitted to the PRC Coordinator at anly_thomas@med.unc.edu.
Disease Group Leaders

2. Final Protocol

  • If your study is a Cooperative Group study (e.g., Alliance), sponsored by a Pharmaceutical company, or sponsored by an outside institution (e.g., Dana Farber, etc.), please include the most recent, approved version of the protocol in the PRC submission.
  • If your study is sponsored by an outside institution (e.g., Dana Farber, etc.), and that institution is an NCI-designated comprehensive cancer center (as indicated on this website: cancer.gov/research/infrastructure/cancer-centers/find), please also include that institution’s SRC/PRC approval letter. If this approval letter is included in the submission, your study may qualify for an Admin review.
  • If your study is a UNC Investigator Initiated study (whether Chemotherapy, Correlative, Health Sciences Research, etc.), you must submit your protocol using a Lineberger Protocol Template. The required protocol number can be obtained from the PRC Coordinator, and additional information about UNC Lineberger IITs is found on the IIT website (unclineberger.org/iit).
    • For UNC IIT’s, please note the policy governing Single Subject Exceptions. This policy applies to all UNC IIT’s and is effective December 1, 2017. 
    • If your study is a UNC IIT and involves an investigational agent (IND) or an investigational device (IDE), additional information must be provided to the PRC with the Initial submission. That information is outlined on the PRC Initial cover sheet. Contact the Clinical Development (unclineberger.org/iit) for assistance with INDs or IDEs.

3. Investigator’s Brochure

  • An Investigator’s Brochure is required for all non-FDA approved drugs or for FDA-approved drugs used in a novel setting. A PRC Reviewer may request an Investigator’s Brochure for an approved drug if he or she finds it to be necessary to adequately review a study. The PRC Coordinator will inform PIs and or Study Coordinators if an IB has been requested by the PRC Reviewer.

4. Biostatistician Sign-Off Sheet – (If UNC Investigator Initiated trial)

Download: Biostatistician Sign-Off Sheet

Any UNC Investigator Initiated study which qualifies for PRC review (Expedited or Full) must have some form of statistical justification. This includes smaller studies, such as those that are sometimes referred to as ‘feasibility’ or ‘pilot’ studies. A smaller study does not abrogate the need for statistical justification. (More about small studies later)

To underline the need for statistical justification and statistical design input, the PRC has enacted a rule whereby all studies submitted to the PRC for review require a statistical sign-off.

While all projects submitted to the PRC for review require a statistical sign-off, that sign-off need not come from a LCCC statistician. However, it should be noted that LCCC statisticians are uniquely qualified to assist UNC investigators, since they have extensive experience in designing studies that meet the requirements required to pass the rigor of PRC Review. Excellent statisticians from the SPH Biostatistics department and other university statisticians may be available to you.

If you are unsure about whether or not you need to use a LCCC statistician, a good first step would be to visit the BIOS Walk-In Clinic that takes place in the atrium of Lineberger on Tuesdays or Thursdays from 12 noon to 1 pm. This provides an opportunity to discuss your project and converse with a LCCC statistician about what steps you might want to take next. Alternatively, you may visit the Lineberger BIOS Core Webpage and find a LCCC statistician to email directly. This statistician may not be the one you work with, but this person would be a good first step to help you find a good fit for your project.

Most researchers are familiar with the use of power and sample size calculations that are used for the statistical justification for a comparative study that tests a primary research hypothesis. However, not all studies are about hypothesis testing. Sometimes the researcher may be interested in estimating a parameter of interest. In this case, the ‘precision’ of this estimate would provide the statistical justification for the study. In all study descriptions, there has to be a measurable ‘something’ that informs whether the study was ‘successful’ or not. It is critical that the PRC be able to easily see what defines and makes your study a ‘success’, and how this success was measured.

Small Study Design

The following describe ‘feasibility’ and ‘pilot’ studies. It should be noted that many studies contain aspects of both:

  • A ‘feasibility’ study is a small study that is often conducted just to see if some aspect of the proposed research is ‘doable’. For example, an investigator may want to see if a questionnaire can be completed by patients at a particular point in time during their treatment. The primary measure of success for this feasibility project would be the proportion of completed questionnaires. The measure of precision for this objective would be the width of the 95% confidence interval of this proportion.
  • A ‘pilot’ study is often a small study with a sample size (often no more than 5 to 15 subjects). A pilot study is often done as a precursor to a larger study. While data from a small study of this kind rarely produces results that are publishable, these studies may gather crucial information that will be used in power and sample size calculations for a larger study, and may also provide important insight into the study design. Regardless, a pilot study must still contain a clear primary objective and a description of what constitutes a successful completion of the study. A successful pilot study may gather important estimates about measures of interest and their statistical variability. Again, these numbers would be useful in future power and sample size calculations.

Often, a small study will contain components of both these studies. Sometimes these studies may be referred to as ‘exploratory’ studies. The main point to remember is that ALL studies, regardless of size, must have a definition of success that is clear and measurable, and must have some justification for the sample size and/or a measure of precision.

5. DSM Charter and/or Monitoring Plan

For industry sponsored, cooperative group and other institution studies, you must provide any DSM Charters and/or monitoring plans that outline safety and data oversight (if applicable) for PRC review, particularly if this is not already clearly outlined in the protocol. If a DSM Charter is referenced in the protocol, it must be included in the submission. If data and safety monitoring information is not provided in the protocol or a separate charter, an email from the sponsor with the following information must be provided:

Outline of safety information to be reviewed; mechanism of safety information review (e.g., via committee? via regular teleconferences with investigators?); frequency of reviews (e.g., after x number of patients enrolled, monthly, quarterly, etc.); mechanism of dissemination of findings to participating sites; description of persons (e.g., PI, participating investigators, separate group of physicians) ultimately making decisions related to the safety information; etc.