Supporting Your Research Trial

Scientific Review Committees Initiate A Study E-Forms & Systems


The Office of Research Services works to facilitate the submission, approval, and maintenance of clinical trials, research projects and grants conducted at Piedmont Healthcare. We offer the following services to our Investigators:
 

Pre-award

  • Reviewing, negotiating, and finalizing clinical trial agreements, master service agreements, and professional services agreements.
  • Oversight of Federal research grants, state research grants, private foundation grants
  • Budget development and negotiations
  • Medicare Coverage Analyses (MCA) and Medicare submissions

 

Regulatory

 

  • Preparation, submission, and maintenance of regulatory documents required by the Piedmont Healthcare Institutional Review Board (PHC IRB), Food and Drug Administration (FDA), study sponsor, and related local and federal agencies.
  • Informed consent and submission development to review committees.
  • Tracking and maintaining regulatory documentation in electronic & non-electronic formats.
     

Institutional Review Board

  • Ethical review of all activities involving human subjects and research within the Piedmont entity.
  • Ensure the protection of the rights and welfare of participants in human subjects research.
  • Function as a privacy board to approve waivers or alterations of HIPAA Authorization.
  • Provide initial and continuing review for and modifications to human subjects research protocols for clinical trial, research projects, and grants conducted at Piedmont Healthcare.
  • Maintain system documentation of projects occurring within the Piedmont entity but not overseen by the PHCIRB.
     

Post-award

  • Research project account set-up Sponsor invoicing.
  • Clinical trial billing research project account reconciliation, reporting, and close-out.
  • Expenditure review cash management.
  • Effort reporting distributions.
  • Cost sharing.
     

Quality Assurance

  • Routine review, assessment, monitoring, and evaluation of data collected in the course of a research project to ensure data are accurate, complete and verifiable from source documents.
  • Review of regulatory documentation to ensure compliance with Code of Federal Regulations and other applicable regulatory requirements.
  • Review of project procedures to ensure compliance with the approved protocol/amendment(s).
  • Thorough documentation of review findings.