FAQs

If your study is a UNC Lineberger Investigator Initiated study (IIT), you MUST use a UNC Lineberger template. More information is on the IIT website (unclineberger.org/iit).

Contact the PRC Coordinator for this.

UNC Investigator Initiated studies which are quantitative and qualify for PRC review require a statistical signoff from the statistician who will be the statistician of record for that study, and therefore responsible for the study. This is to ensure that the study has adequately addressed study design and other statistical issues and is ready for a rigorous review by a PRC statistician.

While quantitative protocols submitted to the PRC for review require a statistical signoff, that signoff need not come from a BIOS SR statistician. BIOS SR statisticians are uniquely qualified to assist LCCC members, since they have extensive experience in designing studies that meet the standards required to pass the rigor of PRC Review. However, if a BIOS SR statistician hasn’t been a collaborator in the design of the study, or will not be overseeing the analyses, and/or will not be a co-author on manuscripts from the study, then they should not take responsibility for, and signoff on, that study. The person who is be responsible for the design and analysis of a study should be the one to sign the statistical signoff. It is highly recommended that this person be a trained statistician, but it need not be a BIOS SR statistician.

Qualitative research involves the process of collecting, analyzing, and interpreting non-numerical data. A study gathering information using focus groups is an example of a study using qualitative research methods. Obviously, this is very different from the quantitative expertise that statisticians have and use. Qualitative studies require a signoff, but not a statistical (or quantitative) signoff. Please contact the PRC coordinator for further clarification concerning a signoff for a qualitative study.

If your study received PRC review at time of initial review it MUST be submitted to the PRC for annual review at the same time as it is submitted to the UNC IRB for annual renewal (UNLESS the study is closed to accrual and there are no patients on active treatment/intervention). The PRC has been mandated by the NCI to review all cancer-related studies for progress and performance, and to close studies to accrual which are not performing in accordance with their stated accrual goals (i.e., low accruing trials). More information about what is required for PRC renewal submissions is found under Instructions for Submitting PRC Materials – Renewals.

For purposes of PRC review, we consider any trial performing at 40% or less of their previously stated accrual goals to be “poor performing.” In these cases, a justification for low accrual MUST be provided in the relevant sections of the PRC Renewal Cover Sheet.

Relevant sections of the PRC Renewal Cover Sheet requesting the rationale for low accrual as well as plans to increase accrual goals should be completed.

Studies which are low accruing and provide sufficient rationale may be approved for continuance without issue, or they may receive a Six-Month Re-Review. The object of a six month re-review decision is to allow for an additional period of accrual to determine if the changes/updates/rationale provided at time of renewal review have been successful in achieving the stated goals. If these goals are not met within that window, the PRC may elect to close a study to accrual at time of re-review.

Depending on the changes, you may be required to submit a modification to the PRC for review. An amendment will either receive an Expedited review, which is intended to take no longer than five business days, or it will be assigned to the next available PRC agenda and receive a Full Board review. View further details on what is required for PRC Amendment Review.