COVID-19 Response 

Access our COVID-19 Response homepage, with more information and resources during the COVID-19 pandemic, including what to do if you’re experiencing symptoms.

Weather Update

Baylor’s Emergency Response Team will continue to monitor tropical storm Beta. Baylor and its clinics will be open under normal business operations on Monday. View message. 




OCR Services


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
    • Assist with informed consent development and translation
    • Assist with development of Data Safety Monitoring Plan and implementation
    • Assist with Investigational New Drug (IND) and Investigation Device Exemption (IDE) submissions
    • Assist with Certificate of Confidentiality submissions
    • Assist with 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

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

Contact Us


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