Protocol Development and Monitoring

Purpose:

Protocol development consultation, scientific and safety peer review, and study administrative monitoring are the responsibility of the Office of Protocol Development and Monitoring. This office collaborates with the CTSC in providing infrastructure for HCCC clinical investigators.

Services provided include:

  1. Protocol development consultation and education.
  2. Coordination of biostatistical consultation with the Biostatistics Core.
  3. Development of data and safety monitoring plans
  4. Accrual monitoring.
  5. Bi-annual and quarterly data and safety audits.
  6. Administrative support of the PRMC and DSMC.
  7. Communication with regulatory offices for oversight of clinical research.
  8. Clinical trial data management and reporting.

Contacts:

Administrative Office: 11510 PFP

Cena Jones-Bitterman, MPP, CIP
Clinical Trials Research Manager
319-353-7846
cena-jones@uiowa.edu

Angela Childs
Clinical Trials Protocol Management Assistant
319-353-7252
angela-childs@uiowa.edu

Marilyn Rosenquist, MS
Clinical Research Safety Officer
319-353-7899
marilyn-rosenquist@uiowa.edu

Brian Smith, PhD
Biostatistician
319-384-5026
brian-j-smith@uiowa.edu

Gideon Zamba, PhD
Biostatistician
319-384-5020
gideon-zamba@uiowa.edu