Pharma Tips

Protocol Data submission To QA in Clinical Research

By: Pharma Tips | Views: 2424 | Date: 07-Dec-2013

Associated with each protocol are various data and compliance evaluation forms. These protocol-specific data need to be submitted to the study group for evaluation at designated time intervals. Usually these data are obtained and prepared by either the clinical research associates (CRAs) or the physics staff. Typical data to be submitted include (physics staff responsibilities are in bold type):

Protocol Data submission To QA in Clinical Research

QA in Clinical Research

Protocol data submission To QA
Associated with each protocol are various data and compliance evaluation forms. These protocol-specific data need to be submitted to the study group for evaluation at designated time intervals. Usually these data are obtained and prepared by either the clinical research associates (CRAs) or the physics staff. Typical data to be submitted include (physics staff responsibilities are in bold type):

1. Demographic data [Health Insurance Portability and Accountability Act
    (HIPPA) compliant]
2. Initial evaluation, history, and physical data
3. Diagnostic pathology report
4. Pathology slides
5. Diagnostic imaging studies [computed tomography, magnetic resonance         imaging, positron emission tomograpy (CT, MRI, PET), gallium, etc.]
6. Preliminary dosimetry information:
    a. Radiation therapy prescription
    b. Patient setup data [simulation, digitally reconstructed radiographs (DRRs), portal images, etc.]
    c. Dose distributions and monitor unit calculations—point doses, isodoses, dose-volume histograms (DVHs)
7. Final dosimetry information:
    a. Daily treatment record
    b. Dosimetry data if any changes from preliminary submission
    c. Dose distributions, calculations, and measurements—point doses, isodoses, DVHs for composite treatment (including any boosts), TLD or diode readings
    d. Patient setup data (simulation, DRRs, portal images, etc.) for any fields not initially submitted
8. Hormone summary
9. Initial and long term follow-up form
10. Autopsy report

Timely submission of the protocol data to the quality assurance center of the cooperative group requires coordination between the institutional CRA and the physics staff. This task deserves the attention and expertise of the medical physicist. The accuracy and completeness of these forms are essential to the success of the cooperative group process. Some protocols require pre-treatment review.  Imaging studies and the treatment plan must be reviewed before the patient receives the first fraction. Some cooperative groups require rapid review of submitted data for some protocols. Typically, the rapid review requires the submission of data within 24 to 72 hours of the start of the radiotherapy. These pre-treatment and rapid reviews require even more diligence on the part of the participating institution’s staff. Most clinical cooperative groups are already set up to receive at least the textual data electronically. Some advanced technology protocols require radiation therapy planning, dosimetry, and verification data to be transmitted electronically to the QA center. The ATC supported by the NCI is developing electronic data archive, retrieval, and review infrastructures that are facilitating the conduct of certain clinical trials. These systems are designed with advanced medical informatic technology, which will allow clinical investigators  to receive, share, and analyze voluminous multi-modality clinical data
anytime and anywhere
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