RRO





The following Services are available through the Pediatrics RRO. For requesting services, please complete the online Consultation/Service Request and TCH Investigational Pharmacy Services Form.
 

  • Assistance with:
    • BRAIN and Affiliate Hospital IRB applications - new, amended and annual renewal submissions and AE/SAE reporting
    • Informed consent development and translation
    • Development of Data Safety Monitoring Plan and implementation
    • Investigational New Drug (IND) and Investigation Device Exemption (IDE) submissions
    • Certificate of Confidentiality submissions
    • Required reporting to clinical trials databases (e.g., clinicaltrials.gov)
  • Liaise with federal agencies and pharmaceutical sponsors
  • Create and maintain electronic master regulatory files for each protocol
  • Electronic maintenance and distribution of protocols and consent forms
  • Storage of research records
  • Administrative coordination with outside sponsors and investigators
  • Oversight and coordination of external audit preparations
  • Conduct internal patient and regulatory audits
  • Identify issues and needs in research procedures; develop and implement SOPs
  • Train clinical research personnel in proper procedures, documentation, and reporting
  • Screen, verify, consent and register study participants
  • Administration of investigational agents, questionnaires, etc.
  • Ordering and facilitating the completion of all study required tests and procedures
  • Ensure patient safety, follow-up and continuity of care during study participation
  • Capture of all data through source documentation and proper recordkeeping, and completion of case report forms (paper and/or electronic)
  • Evaluation and reporting of adverse events in collaboration with the study specific regulatory staff
  • Maintain research charts containing relevant documents for each trial patient
  • Assure compliance with protocol requirements with emphasis on safety, protection of human subject and high ethical standards
  • Proper consenting of patients including protection of patient’s rights and autonomy
  • Maintain ongoing communication with the PI and amongst investigators, clinic nurses, investigational pharmacy, radiology, laboratory, etc. and with external sponsors
  • Experimental design and data analyses
  • Subject Randomization design
  • Abstract, manuscript and preparation (statistical plan)
  • Study design recommendations for retrospective and prospective research efforts
  • Sample size considerations
  • Traditional and advanced statistical methods for data analyses
  • Graphical displays for summarizing data
  • Development of study-specific databases including randomization and electronic case report forms (eCRFs)
  • Maintenance of database of protocols, patient registry and clinical data
  • Entry of clinical and translational data into the database
  • Development of reports for study staff, sponsors, and Data Safety Monitoring Boards
  • Monitoring and reporting of accrual, including tracking of minority recruitment
  • Preparation / distribution of open trials list to investigators and hospital committees
  • Design and development of auxiliary tools and systems to automate workflow and processes
  • Assist investigators with developing grant budgets
  • Assist with grant application and progress report submissions in BRAIN and sponsor agency systems
  • Program Project or Center Grant application coordination support
  • Clinical trial budget development and negotiation with sponsors
  • Facilitate contract review processing in coordination with the Office of Research
  • Assist faculty with time and effort certification
  • Assist faculty with post award administration, including financial reconciliation, financial reporting and sub-award processing