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Regulatory

OCRSS can provide regulatory support to investigators for grants, industry-sponsored, and investigator-initiated research. This support includes, but is not limited to, working with the investigator to get all of the paperwork complete so that the study can be initiated. Our office can act on the investigator's behalf as the primary contact with the study sponsor. The breakdown of regulatory services is as follows:

  • Consent writing and review
  • Preparation of HIPAA documentation
  • Electronic IRB submissions/approvals
  • Hospital research office submission/approvals
  • IRB progress reports 
  • Protocol amendments
  • Reporting of External SAEs
  • Reporting of Local SAEs
  • Database registration 
  • Protocol development
  • Regulatory packet submission
  • Record retention systems for regulatory documents
  • Support during audits
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