The following Services are available through the OCR. For requesting services, please complete the online Consultation/Service Request Form.
Regulatory and Administrative Assistance
- 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.
Clinical Trials Support and Coordination
- 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 and Sponsors Assistance
- 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