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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 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 DXA questionnaire

Schedule the study DXA at 801-8187

After scheduling the DXA, fax the request with the date and time of the DXA scan to: 205-801-8194 “Attention DXA Technologists

A request form should be completed for each study on each patient and faxed to the appropriate office.

Please call DXA Technologists at 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 DXA SCAN REQUEST

Study DXA Request

Study Title:______________________

Study Acct#_______________________

IRB Approval # _____________________________________

Study Visit #:____________________

Scan to be performed________________

Study Site #:_____________________

Patient #: ____________________

Name of Person requesting DXA: _________________________________________________

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 fill out and fax to 205.801.8194 attn: DXA Technologists, prior to the patient coming in for a DXA Scan.

Please schedule the actual DXA at 801-8187.

DEXA/QCT Study Protocol Worksheet

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 DXA scans will be performed throughout the course of the study (estimated)?

How often will DXA 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 DXA scans are requested (peripheral/central, right/left hip, bilateral hips, wrist, spine, total body)

Do scans need to be analyzed each time or for the first screening scan?

Should the DXA scan be provided to your sponsor on paper or on a disk?:
PAPER COPY or DISK (circle one)

Should a physician read the scan? YES NO

Are there other specific instructions regarding DXA scans?

Does a Lateral Vertebral Assessment or an Instant Vertebral Assessment need to be performed? (If yes, circle one)
If Yes – which? – Lateral Vertebral Assessment or Instant Vertebral Assessment

Are the DXA scans sent or picked up? Please provide specific instructions?

Where are the scans sent or who picks the scans up?

What in-service training is necessary for the DXA technician?

Please schedule a meeting with DXA Technologists 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