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.
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.