Regulatory Affairs/Quality Assurance

The Regulatory Affairs/Quality Assurance Unit is responsible for conducting routine internal monitoring visits on research studies conducted at Johns Hopkins All Children's Hospital, to ensure that each study is conducted in accordance with the IRB-approved study protocol, established policies and procedures of Johns Hopkins All Children's Hospital and Johns Hopkins University School of Medicine, and all applicable state and federal laws and regulations.

Key services provided are:

  • Development and training of standard operating procedures related to clinical and translational research Processes
  • Internal monitoring of clinical research activities and quality assurance assistance via:
    • Development of risk-based study monitoring plans;
    • Review of investigator site files/trial master files;
    • Assessment of informed consent processes and participant eligibility;
    • Verification of select source data;
    • Review of investigational product accountability;
    • Evaluation of unanticipated event and/or Serious Adverse Event (SAE) reporting;
    • Review of compliance with Good Clinical Practice (GCP) guidelines for research;
    • FDA / sponsor clinical-investigator-audit preparation and management;
    • Review of overall study compliance with Standard Operating Procedures for clinical and translational research
  • Development of research education and training curriculum in topics such as:
    • Good Clinical Practice (GCP) guidelines for research;
    • Human research subject protection program requirements;
    • Current laws, regulations, policies, procedures, and ethical standards for clinical and translational research;
    • “RA/QA Rounds” highlighting common research compliance issues publicized on the FDA’s website and identifying elements of Johns Hopkins All Children's Hospital CTRO Standard Operating Procedures that address these issues.

Contact Us

Arika Manapat, MS
Research Internal Monitor
[email protected]