Clin. Trials & Protocol Dev.
This section of a SWOG protocol contains eligibility criteria.
What is Section 5?
This section of the SWOG website gives access to many useful reports, tools, information, and links to things like Pre-Rave Data Submission, STS and iMedidata Rave.
What is the CRA Workbench?
The Patient Reports/Data Quality link, found here at SWOG.org, will allow CRAs to access the Expectation and IPR statistics as well as other reports for their institution.
What is the CRA Workbench?
Headed by Laura Gonzales, the purpose of this team is to verify accuracy of submitted data, compliance with protocol & regulatory requirements and to provide educational support.
Who is the SWOG Audit Team?
After 2 years of no contact despite making three attempts, including phone calls and registered letters, a patient is considered this.
What is Lost to Follow-up?
This section of a SWOG protocol contains detailed data submission guidelines.
What is Section 14?
I don’t understand what this form is asking. I don’t know what unit I should report this in. Is my Pt eligible? Why won’t this query go away? Who ya gonna call???
Who is the Data Coordinator at the SDMC?
This static report is run at the beginning of each month and details overdue data as well as upcoming due data for patients followed at an institution.
What is the Monthly Expectation Report?
The SWOG Audit Team is composed of a QA representative and 1 or more of a physician, a nurse, and/or this key SWOG role to round out the team.
What is a CRA?
SWOG Policy #30 explains that when a SWOG Investigator becomes inactive at a site this must be done to the patient.
What is transferred?
These studies are designed to determine the maximum tolerated dose (MTD) of a new therapy.
What are Phase I studies?
We've got queries yes we do! To view queries for your site, go to the SWOG CRA WB and click Queries under Patient Reports/Data Quality. Other reports include this.
What is Expectations, IPR, Ineligible or Patients in Follow-up?
Data from Rave is applied to the SWOG database and updates the reports at this frequency.
What is over night?
Protocol modifications not reviewed within 90 days, delays in annual approval, failure to review long term follow-up protocols and Internal SAEs not reported are all examples of these.
What are IRB deficiencies?
The time frame for reporting these can range from 24 hours to 10 days.
What are Serious Adverse Events (SAEs)?
A quick reference guide to a protocol’s requirements can be found in this section of a SWOG protocol.
What is Section 9?
You’re ready to close a study with your IRB as all of your patients have completed FUP. Look under Study Reports on the CRA WB for this report?
What is Studies with no required follow-up?
This report provides institutions with statistics used to monitor compliance in regard to data submission and patient follow-up.
What is the Institution Performance Review (IPR) Report?
The categories for the Case Review process are Informed Consent, Treatment, Disease Endpoint, Toxicity Assessment, General data quality and this key factor to all clinical trials.
What is eligibility?
Expectations for Specimen submission are resolved only after this is done in the STS.
What is shipping a specimen? (also acceptable, using Notify that Specimen Cannot be Submitted)
This federal government agency supports ~80% of the funding for SWOG trials.
What is the National Cancer Institute (NCI)?
This is how you submit redacted source documents for all Rave studies. (free of Pt identifiers and special characters)
What is upload them?
Institutions are considered out of compliance if this percentage of registrations in the last 13 months is missing any baseline data (Initial Forms Set)
What is 10%?
"Acceptable - see you in 3 years", "Acceptable - Follow up required" and "Unacceptable" are the three ratings given at the end of these.
What are audits?
This US city has been the home to the SWOG Data Operations Center for over four decades.
What is Seattle?