Clinical Research Support

CODI Access and Use

This document describes the process by which investigators can apply for access to data from consented patients in the CODI database.

Overview

The Consortium Oncology Data Integration (CODI) project (IR #5586, protocol 1833) is an FHCRC/UW Consortium clinical research database. It consists of coded variables obtained from EMR systems and manual data abstraction and is designed to meet the following objectives:

  • Aid development and conduct of clinical research on solid tumor cancers by allowing data aggregation on patient populations given a specified regimen or procedure or who recur under such circumstances.
  • Facilitate recruitment, screening, feasibility, and follow-up for research studies concerned with detection, treatment, and prevention of solid tumor cancers.
  • Allow centralized tracking of research subjects enrolled in Consortium studies and reporting on accruals and progress of ongoing studies as currently mandated by government regulations.
  • Enhance care and follow-up of patients with solid tumor cancers.

Patients included in the CODI database are approached for consent 1) to allow their PHI to be used in IRB-approved research projects and 2) for future contact. Flags in the database ensure that only patients who consent to such uses are included in appropriate query result sets. Use of data on patients is restricted to physicians and researchers within the Cancer Consortium and IRB-approved protocols being done in collaboration with Consortium members.

CODI Database Principal Investigators

Barry Storer, PhD
1100 Fairview Ave N., D5-360
Seattle, WA 98109-1024
206-667-6151
bstorer@fhcrc.org

Mac Cheever, MD
825 Eastlake Avenue E., G4-810
Seattle, WA 98109
206-667-4141
mcheever@seattlecca.org

Data Use

Clinical Use of Data

There are no limits to data access for clinical care. Physicians, fellows, nurses, and clinical staff have unrestricted access to data in CODI for all cancer patients. Please refer to the original IRB-approved CODI application and associated documents for details relating to secure data transmission and data access procedures for authorized users.

Administrative use of Data

This mode of data use covers administrative and reporting management for persons who have no reason or need to view patient PHI or medical information. In general, such individuals simply need to provide high-level demographic data or summary statistics to meet institutional, state, and/or federal reporting requirements. Data available to administrative users are anonymized patient records that have been lumped into aggregate classes, i.e., groups in which there is no one-to-one correspondence between the number of records in the data file and the number of patients represented (e.g., number of breast cancer surgeries in a given year). If these are data/statistics that will be needed on a regular basis, a canned query will be written and those administrators making the requests will have access to only those query results and no other data in CODI.

Research Use of Data

Physicians and researchers within the Cancer Consortium and their staffs may access data in CODI for research purposes if approved by the Database Oversight Committee (DOC) and as specified in their IRB-approved protocols (see below). A signed copy of the IRB-approved protocol cover page must be provided to the database administrator prior to data access. The database administrator will then set up restricted access for that researcher and his or her staff using the IRB protocol number. All database usage associated with that number will be tracked in the audit trail.

Reviews Preparatory to Research

Per NIH, researchers may review data in CODI for reviews preparatory to research without IRB review. These reviews allow investigators to determine, for example, whether the database contains a sufficient number or type of patient or data records to conduct the research under consideration. An audit trail of use associated with reviews preparatory to research is maintained in the database.

Procedure for Data Access

The Data Oversight Committee (DOC) controls research access to cancer patient data in CODI and monitors its research use. The purpose of the DOC is to ensure that valid and productive scientific use is made of data stored in CODI and that data are used in a manner agreed upon by all stakeholders. The Committee consists of 4-5 members, with representation from several disciplines (e.g., surgery, medical oncology, imaging). The Committee is chaired by the PI of the CODI study. The DOC meets on an as-needed basis to review research requests for data access.

Requests Exempt from DOC Review

  • Clinical queries
  • QA/QC queries
  • Data queries preparatory to research
  • Data queries for a PI related to data analysis for an IRB-approved clinical trial

Requests Requiring DOC Review

  • Queries on data from a clinical trial for any researcher other than the PI
  • Any other data queries or research that would require IRB approval

Any requests that do not meet one of the above criteria must be submitted to the DOC for review. After evaluation, the DOC will decide whether such requests will require its review in the future. Researchers should obtain DOC approval before submitting their research proposals to the IRB.

The process for submitting proposals to the DOC is as follows:

1. The research PI must submit a proposal to the DOC Chair, which should include:

  • PI name, Address, Phone, Fax, Email, Co-investigators, Funding source
  • Project Title
  • Abstract
  • Proposal (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods, Literature Cited, NIH biosketch of the PI). If research requires that patients be contacted, targeted study population and how contact will be made must be specified. CODI variables being requested must also be listed. In the case of junior scientists, a letter of support is required from the individual in whose lab the work will take place.

2. The proposal will be circulated to all DOC members for review and evaluated according to the following criteria:

Does the proposal use CODI data in an appropriate manner?

  • Is the question of considerable scientific and/or medical interest?
  • Is the study design appropriate to address the question?
  • Can data in CODI answer the question(s) being asked?
  • How difficult will it be to obtain the data?
  • Will there be additional costs to support this project?

Do the researcher and his/her research team have appropriate qualifications and experience to conduct the study?

3. Comments and suggested changes to the proposal will be summarized. A report will then be forwarded to the proposal PI with a request for changes, if necessary.

4. After making requested changes, the PI will submit a final version of the proposal with a completed IRB application to the DOC chair. If no further changes are required, a certification letter signed by the DOC Chair/PI of the CODI study will be provided and the entire packet submitted directly to the IRB.

5. After submission to the IRB, the proposal PI will be sent a CODI Data Use Agreement (DUA). While the proposal is undergoing review by the IRB, the proposal PI should gain appropriate institutional signatures on the DUA. No data will be released to the PI until the CODI data administrator receives the signed IRB cover page and signed DUA.

6. Every effort will be made to complete this entire process within four weeks' time.

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