Please note the following changes to PRC submission processes:
- Effective February 01, 2013, all initial submissions of Pharmaceutical/Industry Sponsored studies and studies sponsored by other institutions for which UNC is a participating site must be submitted via IRBIS (i.e., the online IRB system) to be scheduled for PRC review. Studies submitted by the relevant deadlines will be scheduled for both a PRC Meeting and a related IRB Meeting to take place five days subsequent to the PRC Meeting. There may be circumstances when this is not possible, in which case it will assigned to the next available meeting(s). Please note: The one exception to the above are Pharma/Industry studies receiving Centralized IRB (CIRB) review (see last bullet below for more information).
- To ensure your study can be reviewed at both the PRC and IRB as above, submissions to the IRBIS system must include all required PRC submission materials uploaded into the IRBIS system. In addition, all departmental signoffs must be completed prior to the PRC Deadline. Incomplete submissions or submissions which do not meet the above requirements will not be considered for review.
- Additionally, please note: In order to provide consistency in review and maximize oncology expertise on the IRB, we have worked in conjunction with the IRB to designate Committees B and D of the standing Biomedical IRBs as oncology-specific. These two Committees will manage initial reviews for all oncology trials, while amendments and renewals will continue to be assigned to any committee.
- At this time, all UNC Investigator Initiated studies, Cooperative Group (and/or studies which have received external scientific peer review), and studies using CIRB for IRB processing, should still be submitted directly to the PRC Coordinator via email with all required documents by the PRC deadline to ensure timely review. These studies should NOT be submitted through IRBIS until AFTER PRC review and final PRC approval is achieved.
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 Protocol Office (CPO), while some trials will use other resources. If you are not sure what you need, please contact the PRC Coordinator 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 RDRC site here.
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.
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 are aware of the study, and have 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 trails 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, please obtain a signature from each Leader from the relevant group.
To obtain a signature, please ensure you forward your final protocol and the signoff form 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 via email to the PRC Coordinator
|GI||Autumn McRee||Head and Neck||Jared Weiss|
|GU||Tracy Rose||Phase I||Claire Dees|
|Breast Cancer||Claire Dees||Neuro||Simon Khagi|
|Lung||Jared Weiss||Lymphoma||Anne Beaven|
|Melanoma||Stergios Moschos||Multiple Myeloma||Sascha Tuchman|
|Cellular Therapeutics||Jon Serody||Leukemia||Josh Zeidner|
|Gynecology Oncology||Victoria Bae-Jump|
2. RAFT Approval (CPO Managed studies only)
Approval by the RAFT Committee is required for all CPO managed studies. Please ensure documentation of this approval is included in your submission (Please note: this replaces the requirement for Prioritization Checklists).
3. Final Protocol
- If an Industry Sponsored, please upload into IRBIS the most recent, approved version of Sponsor protocol for review.
- If a protocol is investigator-initiated from an outside institution (such as a protocol originating from Dana Farber, MGH, USC, etc.), please upload the most recent, approved version of the sponsoring institution protocol into IRBIS for review. This protocol MUST have a cover page/header indicating that the submitted document is the FINAL VERSION and either feature a version number or version date. All protocols without this information clearly indicated will not receive PRC review.
- If no version is available with this information, please upload the IRB Approval from the sponsoring institution of the version of the protocol you are providing to ensure this is an approved, current version of the study.
- If your study is a UNC Investigator Initiated study, you must submit your protocol using a Lineberger Protocol Template. This should be submitted, along with all other relevant submissions documents, directly to the PRC Coordinator via email.
- NEW!!: For UNC IIT’s, please note the policy governing Single Subject Exceptions here. This policy applies to ALL UNC IIT’s and is effective December 01, 2017.
- If your study is a correlative science study (any study involving sample collection with or without supporting data), you must use the Correlative Science Template. This should be submitted, along with all other relevant submissions documents, directly to the PRC Coordinator via email.
- If a Cooperative Group/ Externally Peer Reviewed trial, provide the most recent, approved version of Sponsor protocol for review. This should be submitted, along with all other relevant submissions documents, directly to the PRC Coordinator via email.
4. Investigator’s Brochure
- 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 via email to the PRC Coordinator (along with all other required PRC documents).
- Note: An Investigator’s Brochure is required for all non FDA approved drugs for Phase I, II and III Studies. 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.
5. Biostatistician Sign-Off Sheet – (If UNC Investigator Initiated trial)
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 measureable ‘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 measureable, and must have some justification for the sample size and/or a measure of precision
6. DSM Charter and/or Monitoring Plan – For industry sponsored/cooperative group/other institution studies, you must provide any DSM Charters and/or monitoring plans that outline safety and data oversight for PRC review (if applicable), particularly if this is not already clearly outlined in the protocol. Studies without clearly outlined plans for data and safety monitoring will receive stipulation at time of PRC review (or may be deferred).