Data Management

The purpose of the Clinical Trials Office (CTO) is to provide support to clinical investigators in initiating and conducting clinical trials, as well as collecting and preparing clinical trial data for the reporting of results from clinical trials. Clinical trials and data monitoring plans are required to be registered with the CTO. The CTO is responsible for: the initiation and maintenance of regulatory files, identification and extraction of source documentation for entry into centralized clinical databases and/or corresponding case report forms, assistance with the processing of protocol specimen collection and shipping, collaboration with the research team to maintain and coordinate the efficient and accurate collection of data and regulatory documentation, regular communication with the research team regarding study-related data collection and reporting issues, assistance in the preparation and submission of regulatory applications, including any ongoing amendments, annual renewals, data safety reports as determined by the Yale Cancer Center Data and Safety Monitoring Committee (DSMC) and submission of all other related protocol documents, maintenance of individual research subject records by obtaining medical records, lab reports, treatment schedules, and other vital protocol-related information and assistance in HIC submissions, protocol revisions, and renewal processes as required.

Contact

Quick Links

• Specimen Handling and Processing
• Trial DB
• Protocol Review and Monitoring including DSMC and Data Safety and Monitoring Plans
• Human Investigations Committee Policies and Procedures
• CALGB
• GOG
• RTOG
• HIC Protocol Deviation Form
• HIC Annual Renewal Form 5
• HIC SAE Reporting (6A) Form: Yale Subject
• HIC SAE Reporting (6B) Form: Non Yale Subject
  
• International Conference on Harmonization (ICH)
• WHO: Standard Operating Procedures for Investigators
• Good Clinical Practices
• National Cancer Institute
• Cancer Therapy Evaluation Program