The St. Jude Children's Research Hospital Comprehensive Cancer Center (SJCCC) Clinical Trials Scientific Review Committee (CT-SRC) serves as the internal, expert body responsible for reviewing the scientific rationale, feasibility, and study design of all clinical research protocols opened within the SJCCC. As an additional and related function, the CT-SRC monitors the progress of all SJCCC protocols, ensuring that they adhere to the approved study design;achieve their accrual goals in a timely manner;adhere to approved stopping criteria;and that patient safety is maintained. The CT-SRC has the authority to recommend protocol modifications and to close studies. The CT-SRC works in close collaboration with the other clinical trials oversight committees within the SJCCC including the IRB. Together, these complementary but non-overlapping bodies ensure the appropriate and safe conduct of high-quality clinical research within the SJCCC. Administratively, the CT-SRC is coordinated through the Central Protocol Data and Monitoring Office (CPDMO). The CT-SRC serves as the final step in a significant, formal, clinical trials concept development process within the SJCCC. The initial responsibility for developing high-quality, appropriately designed clinical trials lies at the level ofthe SJCCC Programs. To this end, each of our Programs that treat patients run clinical trial development efforts that invest great time and effort in protocol development prior to central review. To further enhance the efficient development of clinical trials by the SJCCC Programs, in July of 2012, the CT-SRC implemented a Concept review process for all SJCCC. investigator initiated studies. Additional changes made in the grant cycle period include adoption of a risk-based model for monitoring of clinical trials, formalizing a policy for accruals monitoring by the CT-SRC, and strengthening the committee membership with additional senior researchers. In summary, the SJCRH Protocol Review and Monitoring System evaluates and monitors all prospective clinical trials for scientific merit and alignment with the goals of the SJCCC.
Showing the most recent 10 out of 6764 publications
