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The Sue and Ralph Stern Center for Cancer Clinical Trials and Research

Clinical Protocol and Data Management (CPDM) functions are carried out within the CFCCC’s Stern Center for Cancer Clinical Trials & Research, which houses the Clinical Research Office (CRO) and the Regulatory Affairs Office (RAO). Both offices provide a centralized mechanism to support CFCCC clinical research and aim to enhance the ability of CFCCC members to conduct clinical cancer research within all NCI, federal and state regulatory requirements. These Offices facilitate and support the conduct of interventional and treatment clinical trials. RAO and CRO services are provided for the entire lifecycle of a research study, which includes development and implementation support, as well as quality control functions. In addition to assistance specifically related to the planning and conduct of study protocols, RAO and CRO work closely with the Clinical Informatics Department of UC Irvine Medical Center to manage the CFCCC clinical trials management system, OnCore, which houses protocol-specific data necessary for planning, reporting, and internal oversight, as well as tracking of activities, workloads and other key metrics.

The CRO provides central management and oversight assistance for coordinating and facilitating the study management needs for cancer clinical trials for the CFCCC. Clinical research coordinators (CRCs) are assigned to multiple specific disease-oriented teams (DOTs) to aid in the organization and operations of the clinical research enterprise and to provide workflow consistency to the Investigators conducting the trials. The CRO established three separate teams who each handle several disease sites.

CRCs assist Investigators by coordinating and executing clinical trial activities, which include:

  1. Screening and assisting with the consenting of research subjects
  2. Educating subjects regarding the trial
  3. Registering subjects to clinical trials
  4. Collecting and recording study-related data
  5. Completing case report forms
  6. Coordinating specimens and samples
  7. Coordinating and overseeing monitoring visits
  8. Monitoring and reporting serious adverse events
  9. Facilitating subject follow up

The RAO provides central management and oversight assistance for coordinating the regulatory needs of cancer clinical trials. The office is separated into two components, committee coordination and regulatory submissions.

The committee coordinators manage the following administrative activities, which include:

  1. Intake and pre review of all submissions;
  2. Querying the Investigator for additional information, if necessary;
  3. Writing minutes for all committee and DOT meetings;
  4. Writing formal correspondence of stipulations to Investigators;
  5. Managing and coordinating all DOT, PRMC, and DSMB meetings;
  6. Creating OnCore data entry upon receipt of initial protocol submission.
  7. Managing clinical trial registration with Clinical Trial Reporting Program and clinicaltrials.gov;

 The regulatory coordinators manage the following regulatory activities, which include:

  1. Conducting pre-qualification site initiation visits;
  2. Preparing and submitting all regulatory committee applications (DOT, PRMC, DSMB, and IRB)
  3. Preparing and submitting ancillary committee applications as needed (e.g. conflict of interest, radiation safety, biosafety, etc.)
  4. Creating consent forms;
  5. Creating and maintaining regulatory binders;
  6. Tracking and processing external safety reports; and
  7. Updating OnCore as new studies obtain approval and activate, etc.

Organization of the CPDM function:

 OC

 Further Information-

Clinical Research Office Manager: Janis DeJohn
Phone: 714-456-6056

Regulatory Affairs Manager: Cynthia Mann
Phone: 714-456-6472

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