Research

Services

Master
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OCR Services

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

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Regulatory and Administrative Assistance

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  • 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.
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Clinical Trials Support and Coordination

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  • 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
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Grants, Contracts and Sponsors Assistance

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  • 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
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Contact Us

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Please email questions and requests to ClinicalResearch@bcm.edu.