Attachment W2 for UCH Clinical Trials Office (CTO) Utilization form
Submit all required documents in electronic format to Diane Branham ([email protected]) and cc Susan Switz ([email protected] ) for approval. COMIRB Number
Protocol Title:
PI: Phone PRA ( Study Phone Coordinator) : Regulatory Phone Contact: Billing Contact: Phone
Sponsoring Entity: ______
I. STUDY DESIGN
A. Study Phase: Phase I Phase II Phase III Phase IV Not applicable Not known
B. Is this a Multi-Center study? Yes No If yes, list # Centers
C. Is there an IND? Yes No If yes, list IND number
D. Is there an IDE? Yes No If yes, list IDE number
E. Duration of Study: What is the expected duration of this study?
F. Study Participants: How many subjects will be screened for enrollment? How many total subjects will be enrolled in the study? How many subjects will be enrolled in Year 1?
G. Will a DSMB be responsible for the ongoing review of adverse events and serious adverse events? Yes No
1. If yes, please attach a copy of the DSMB charter.
2. If no, please describe the data, safety and monitoring plan for this study in this section.
II. ONE YEAR PROJECTED UTILIZATION OF CTO FACILITY
A. SCREENING VISITS
1. Total number of subjects you will screen in the CTO facility? 2. Approximate Length of screening visits in CTO facility (hrs)?
B. OUTPATIENT VISITS
Attachment W for UCH Clinical Trials Office (CTO) Utilization Form CF-111, Effective Date 6-8-2011 1. Total number of subjects you will see in the CTO facility per year? 2. Total number of outpatient visits per subject (do not include screening visits)? 3. Approximate Length of outpatient clinic visits in the CTO facility (hrs)? Provide additional details pertaining to OP visits if necessary: 4. Total number of after hour blood draws?
C. INPATIENT ADMISSIONS (Subjects requiring an overnight stay)
1. Total number of subjects to be admitted to CTO facility per year? 2. Total number of inpatient admissions per subject? 3. Length of each inpatient admission to CTO facility (please check) 1 day 2 days 3 days 4 days 5 days other
III. RESEARCH NURSING SERVICES requested (please check)
Screening OP Visits IP Visits History and Physical ( by PA or NP) Phlebotomy After Hours Blood Draws Exercise Testing Chemotherapy Drug Infusions Pharmacokinetics sampling Biopsy Echocardiography Dexa Scans Electrocardiograms(ECG’s) Laboratory Processing of Samples Laboratory Storage of Samples Laboratory Assays (comprehensive list found in CTO instructions)
Other Services Needed:
IV. BIONUTRITION SERVICES Contact Janine Higgins, PhD, at UCHSC 720-848-6674
A. Does your CTO protocol require specialized research meals? Yes No If yes, please answer the following: 1. Are any meals to be served on the unit? Yes No If yes, which visits?
2. Are any meals to be consumed off the unit? Yes No If yes, when?
3. Are meals to be controlled for specific nutrients? Yes No If yes, list nutrients:
B. Would you like to assess subjects’ dietary intake as part of your protocol? Yes No
Attachment W for UCH Clinical Trials Office (CTO) Utilization Form CF-111, Effective Date 6-8-2011 If yes, please answer the following: 1. What specific dietary parameters would you like to assess? (e.g. kcal, protein, etc.)
2. At what time points would you like diet assessed?
1. How will the dietary data be used / reported?
A. POLICY AGREEMENT
By signing and dating this contract you are stating that you agree to comply to ALL policies associated with conducting Clinical Trials at University of Colorado Hospital. 1. If patients wait on coordinators or PIs that are running late, the study will be charged for this time. 2. I agree that ALL services on the CTO Charge Master will be billed if they are used. The HRRC Business Plan is not a contract, it is a guide. In order to have enough money in the budget we suggest you plan for extra funds for items that are invoiced. 3. I agree to email AND call the CTRC Program Assistant, Susan Switz, regarding ANY disputed charges prior to sending the invoice back to the finance department. 4. I agree to pay CTO bills within thirty days of receipt. If I do not comply with this, I accept that the CTO department will have to temporarily close the protocol until outstanding bills are paid. 5. Write offs will not be approved until the chart is pulled and documentation supports the write off. 6. “Proof of activity” on the CTO Price List must be confirmed and approved with in 48 hours of Susan scanning and emailing them to the Billing Coordinator. 7. Bills are not to be disputed after Billing Coordinator has approved them to be charged. 8. Patients are not to be scheduled with out the grant number issued by the HRRC office.
X______date______Physician Investigator
X______date______Regulatory Coordinator
X______date______Billing Coordinator
X______date______Study Coordinators / Professional Research Assistant
X______date______CCTSI Clinical Nursing Director
Attachment W for UCH Clinical Trials Office (CTO) Utilization Form CF-111, Effective Date 6-8-2011