BONE QCT Study

Protocol Instructions To assist us in providing better service for your protocol please prepare a package with the following documents. Please bring this package with you when you schedule your appointment with the DXA/QCT technician. 1. Study Protocol 2. Informed Consent and copy of the IRB approval form 3. Copies of Necessary forms 4. Quality Assurance schedule if necessary 5. Copy of completed QCT questionnaire Schedule the research BONE QCT scan at (205) 731-9380,option #1. Specify that the Bone QCT exam should be done on the GE Light Speed CT Scanner on the 3rd floor TKC. After scheduling with Radiology Scheduling, fax the request with the date and time of the bone QCT to (205) 801-8194: “Attention DXA techs”. A request form should be completed for each study on each patient and faxed to the appropriate office. Please call DXA Technologists at (205) 801-8864 or 801-8745 with questions and to schedule a meeting about your protocol. The Clinical Trial Billing form in this packet should also be completed.

RESEARCH QCT SCAN REQUEST Study Title:______________________ Study Acct#_______________________ IRB Approval # ______________________________________ Study Visit #:____________________ Scan to be performed________________ Study Site #:_____________________ Patient #: ____________________ Name of Person requesting QCT: __________________________ Phone: ______________________ Pager:________________________ Referring Physician: ______________________________ Name of Patient: _________________________ DOB: ____________________ MRN: _____________________________ If no MRN, please complete the following: Patient’s SSN: _____________________Sex: ___________________ Address: _________________________________________ __________________________________________ Home Phone: _____________________ Work Phone: ______________________ Emergency Contact’s Name: ____________________ Phone: _______________ Research Staff Instructions: Date of Scan:________________________ Time of Scan:_______________________ If you have any questions, please contact DXA Technologists at 801-8864 or 801-8745 Please schedule the actual Bone QCT study at 731-9380, option 1 for CT scan. Scans should be completed on the GE Light Speed Scanner- 3rd floor TKC

QCT Research Protocol Worksheet Scans should be completed on the GE Light Speed Scanner- 3rd floor TKC Name of Protocol: Protocol Account Number: IRB Approval #: Sponsor: Duration of Study: Contact Information: Name: Title: Phone: Pager: Address: Fax: Has human use approval been obtained for this protocol? Yes No Please provide a copy of the IRB Approval and the Informed Consent document to the DXA technologist. How often does quality assurance testing need to be completed? Please provide a specific schedule if it is required. How often does the quality assurance information need to be transmitted to the sponsor? List specifics of quality assurance testing: Who should be notified of software/hardware changes? How many QCT scans will be performed throughout the course of the study (estimated)? How often will QCT scans be completed on each research subject? Please list screening-monthly or visit #; Pt. ID#, and which study is to be done on each visit. What QCT scans are requested (spine, hips) Should a physician read the scan? YES NO (circle one) Should the QCT scan be provided to you on paper or on a disk?: PAPER COPY or DISK (circle one) Are there any other specific instructions regarding QCT scans? Are the QCT scans sent or picked up? (provide specifics) Where are the scans sent or who picks the scans up? (Provide specifics) What in-service training is necessary for the technician? Please schedule a meeting with the DXA techs at 801-8864 or 801-8745 to discuss the study needs. Has the billing been set up for this protocol? Please list any special instructions. Please fill out the Clinical Trial Billing form UAB Clinical Trial Billing Notice. Contact Carolyn McDowell in the Office of Research Compliance at 934-9564 with questions.

Additional Comments: Please fill out and fax a copy of Study DXA request before each patient comes in for a scan. Fax to: 205-801-8194 ATTN: DXA Technologists