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The Gynecologic Oncology Group (GOG) is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of Gynecologic malignancies. Approximately 45 individual clinical trials are active at any one time within GOG for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, and cervix. The GOG has recently joined with the National Surgical Adjuvant Breast and Bowel Project and the Radiation Therapy Oncology Group to form NRG Oncology. The GOG developed a Web-based data entry system utilizing Cardiff TELEForms, JavaScript, ASP and ASP.NET/C#. The eCRFs are designed in TELEForms and displayed via secured session SSL Web browsing session to the user in PDF format. The questions residing on the PDF forms are CDE compliant questions and the underlying logic is based upon the valid/permissible values contained within the CDE database. The years of experience using the CDE browser positioned GOG to easily adapt to the use of CDEs within the GOG’s instance of RAVE and carry through this knowledge to the NRG. During the transition to RAVE the IT staff worked closely with the NCI, CTEP and CTSU staff to develop a methods for the LPOs to capture NCI eCRF standard within their local terms and derive those values to the NCI standard fields or the reverse. This enables the data reported back to CTEP to be provided in caDSR values while at the same time allow the LPOs to continue leveraging existing processes. |
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