Residual Scope: Risk-Stratified Randomized Phase III Testing of Blinatumomab in First Relapse of Childhood B-Lymphoblastic Leukemia

Overview of Principal Investigator (PI) Responsibilities: Be responsible for leading team of co-investigators and any other personnel participating in the conduct of the Study. In compliance with applicable governmental requirements and the Protocol, prepare, document and maintain records and case histories on case report forms, retain such data and records after completion of the Study, and obtain advance informed consent from each of the subjects (or their duly authorized representatives) participating in the Study. Report any adverse reactions during the course of the Study of which they become aware in accordance with applicable governmental requirements and the Protocol. Permit representatives of COG, the National Cancer Institute (NCI), or study sponsor to examine the institution¡¦s respective facilities, validate case reports against original data in the files of institution, make copies of relevant records, monitor the work performed, determine the adequacy of the facilities and whether the Study is being conducted in compliance with the Protocol and relevant governmental requirements. Maintain appropriate records of Study drug received, dispensed, used, and returned by subjects, as well as records of any Study drug returned to sponsor, in accordance with applicable law and the Protocol. Supervise the prompt processing and dispersal of diagnostic materials, required data, research materials, and pathological specimens as designated in the protocol. Oversee the regulatory aspects of the study at the institution by submitting protocols, amendments and safety reports to the Institutional Review Board (IRB) in a timely manner, and ensuring that all regulatory requirements are met.