Continuing Review: UW-Madison Purview Enrollment Guidance
The continuing review application includes a page to collect subject enrollment information only for those studies that enroll subjects at sites under UW-Madison IRB purview. This documents provides guidance on how to answer the subject enrollment questions on this page. 1.1 Based on the currently approved IRB application, the IRB has approved following number of subjects for enrollment at sites under UW-Madison purview (includes sites for which the UW serves as IRB of record). No answer is required for this question. This information is automatically populated from existing study information in ARROW. It is provided here as a reference for study teams. 1.2 Provide the total number of subjects who provided consent and were enrolled to date at sites under UW-Madison purview. List the total number of subjects who have provided informed consent to participate in this study and have begun study procedures (e.g., study treatment). Subjects who complete screening procedures and fail screening are not included in this number. Subjects who were consented and began study procedures/treatment, but were subsequently withdrawn by the investigator or voluntarily withdrew should be included in this number. 1.3 Provide the total number of additional subjects yet to be recruited and enrolled at sites under UW-Madison purview. Indicate the number of additional subjects that you plan to recruit to this study. This number of subjects yet to be recruited and the number already enrolled should not exceed the overall number approved by the IRB for enrollment. If you wish to increase the number of subjects to be enrolled, please submit a change of protocol. 1.4 Has the rate of subject enrollment been lower than expected? Indicate whether the rate of subject accrual to the study has been lower than the rate expected and, if so, briefly explain why when prompted in ARROW. 1.5 Has subject enrollment been temporarily halted or suspended since initial review or the last continuing review, whichever is most recent? Indicate whether subject enrollment has been stopped or suspended and, if so, briefly explain why (e.g., due to interim data analysis, temporary loss of funding) when prompted by ARROW.
Version Date: September 28, 2017