Df hcc clinical trials audit manual

NCT ID: NCT (View complete trial on www.doorway.ru) DFCI Protocol ID: This research study is studying an immunotherapy drug, as a possible treatment for oral proliferative verrucous leukoplakia (OPVL). Process Audit - A systematic review of a specific aspect of a single clinical research process across trials, disease programs, and research locations. Mock - An informal audit performed to assist in preparations for an external audit or inspection. Audits may also be requested by a DF/HCC oversight committee (CLC, IRB, DSMC, DSMB, etc.) or DF/HCC leadership in response to specific observations . Provide support for the maintenance of the DF/HCC Clinical Trial Audit Manual, DF/HCC Standard Operating Procedures (SOPs) pertinent to clinical trial auditing and the audit database Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encountered by the clinical research auditors across the DF/HCC institutions.

Internal Audits by ODQ. All DF/HCC research is subject to internal audits by the Office of Data Quality (ODQ) per DF/HCC policy AUD Audits and Inspections. The PI and research team will be notified if a study is selected for audit. AUD-OP Internal Auditing Procedures (DF/HCC operation) Guidance on Responding to Audit Findings(DF/HCC guidance). The ODQ Internal Auditing Program is an integral part of the DF/HCC’s clinical research compliance oversight and quality assurance activities. The auditing of clinical trials at the DF/HCC helps to ensure research participant safety, acquisition of high quality data, and compliance with Federal and State Regulations and Institutional policies and procedures. The auditing of clinical trials at the DF/HCC helps to ensure research participant safety, acquisition of high quality data and compliance with Federal and State Regulations and Institutional.

research program, and utilize HCC Shared Resources. deviations, and audit reports regardless if they utilize the HCC Clinical Trials. Under the IU Simon Cancer Center Clinical Trials Office. M. Contreraz, S. Edwards, workflow documents created to assist and reinforce trial procedures. The DF/HCC has a vested interest in the quality of the research that is is responsible for internal auditing of clinical trials within the DF/HCC.