Monitoring and quality assurance
toxicity, ICH, Cancer
ADVERSE EVENT, ADVERSE EVENT, CANCER
The clinical site will perform internal quality management of study conduct, data and biological specimen collection, documentation and completion. An individualized quality management plan will be developed to describe a site’s quality management. Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be generated. Any enrollment data or data anomalies will be communicated to the site(s) for clarification/resolution.Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is conducted and data are generated and biological specimens are collected, documented (recorded), and reported in compliance with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).The investigational site will provide direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities.The clinical research team will meet on a regular basis (approximately weekly) when participants are being actively treated on the trial to discuss each participant. Decisions about dose level enrollment and dose de-escalation, if applicable, will be made based on the toxicity data profile Adverse events, deviations, response evaluations, and all other study related issues will be reviewed at this time.All data will be collected in a timely manner and reviewed by the principal investigator. The principal investigator will review adverse event and response data on each participant to ensure safety and data accuracy. The principal investigator will personally conduct or supervise the investigation and provide appropriate delegation of responsibilities to other members of the research staff.The agents will be supplied by CTEP (Cancer Therapy Evaluation Program), NCI (National Cancer Institute) and used in this protocol is/are provided to the NCI under a Collaborative Agreement (CRADA) between the Eli Lilly and the NCI Division of Cancer Treatment and Diagnosis.