Services

The following Services are available through the OCR. For requesting services, please complete the online Consultation/Service Request Form.

• Assistance with
  • BRAIN and Affiliate Hospital IRB applications - new, amended and annual renewal submissions and AE/SAE reporting.
  • Informed consent development and translation.
  • Guidance for Investigational New Drug (IND) and Investigation Device Exemption (IDE) submissions.  See further details here.
  • Certificate of Confidentiality submissions.
  • Setup of new clinical trial.gov accounts and guidance and assurances for required reporting to clinical trials databases (e.g., clinicaltrials.gov).  See further details here.
• 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.

• 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

• Grants, Contracts & Sponsors Assistance
• 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