University of Colorado Hospital

Clinical Trials Office (CTO)

COMIRB Attachment W 2- UCH CTO Utilization Form

COMIRB #: / ENTER PENDING IF NOT AVAILABLE
PROTOCOL #:
G CODE: / ENTER PENDING IF NOT AVAILABLE
SPEEDTYPE: / ENTER PENDING IF NOT AVAILABLE
SPONSOR:

PROTOCOL TITLE:

Summary of Study Personnel

1.1* Principal Investigator: *Enter First Name, MI, Last Name Degree:

Page 1 of 4

COMIRB Attachment W for UCH Clinical Trials Office (CTO) Utilization Form

F-111, Revision 003, Effective Date 03/01/2012

Department: *Enter PI department information here

Phone #: *PI contact numberPager #: *PI pager number

1.2 *Information for Study Coordinator:

Study Coordinator/Contact Name:*Enter First Name, Last Name Degree:

Page 1 of 4

COMIRB Attachment W for UCH Clinical Trials Office (CTO) Utilization Form

F-111, Revision 003, Effective Date 03/01/2012

Phone #:*Contact phone # Pager #:*Pager #

1.3 *Information for Regulatory Contact:

Regulatory Coordinator/Contact Name:*Enter First Name, Last Name Degree:

Page 1 of 4

COMIRB Attachment W for UCH Clinical Trials Office (CTO) Utilization Form

F-111, Revision 003, Effective Date 03/01/2012

Phone #:*Contact phone #

1.4 *Information for Budget Specialist:

Budget Specialist/Contact Name:*Enter First Name, Last Name Degree:

Page 1 of 4

COMIRB Attachment W for UCH Clinical Trials Office (CTO) Utilization Form

F-111, Revision 003, Effective Date 03/01/2012

Phone #:*Contact phone #

1.5 *Information for Billing Contact:

Billing Contact/Contact Name:*Enter First Name, Last Name Degree:

Page 1 of 4

COMIRB Attachment W for UCH Clinical Trials Office (CTO) Utilization Form

F-111, Revision 003, Effective Date 03/01/2012

Phone #:*Contact phone # Campus Box:*Box #

2. Study Design

(To check box, double click on box and change default value to checked)

All CTO studies must comply with the UCH CTRC Study Monitoring Policy.

2.1Study Phase: Phase I / Phase II / Phase III / Phase IV / Not applicable / Not known

2.2Is this a Multi-Center study?Yes NoIf yes, list # Centers

2.3Is there an IND?Yes NoIf yes, list IND number

2.4 Is there an IDE?Yes NoIf yes, list IDE number

2.5 What is the expected duration of study?

2.6 Will a DSMB be responsible for the ongoing review of adverse events and serious adverse events?

Yes No

A. If yes, please attach a copy of the DSMB charter.

B. If no, please describe the data, safety and monitoring plan for this study in this section.

3.Summary of Requested CTO Services

Check and complete only items that apply to your study

3.1Screening Visits

3.1.1 Total expected number of subjects you will screen for enrollment:

3.1.2 Approximate length of screening visits in the CTO facility (hrs):

3.1.3 Total number of subjects you will enroll in the study:

3.1.4Total number of subjects you will enroll in Year 1:

3.2Inpatient Admissions(subjects requiring overnight stay)

3.2.1Total number of subjects to be admitted to the CTO facility per year:

3.2.2Total number of inpatient admissions per subject:

3.2.3 Length of each inpatient admission to CTO facility (please check):

1day2 days3 days 4 days5 days other

3.2.4 What study visits will the subjects be seen in the inpatient CTO facility:

3.2.5 Provide additional details pertaining to IP visits:

3.3Outpatient Visits

3.3.1 Total number of subjects you will see in the CTO facility per year:

3.3.2 Total number of outpatients visits per subject (do not include screening visits):

3.3.3 Approximate length of outpatient clinic visits in the CTO facility (hrs):

3.3.4What study visits will the subjects be seen in the outpatient CTO facility:

3.3.5 Provide additional details pertaining to the OP visits:

3.3.6 Will you need to utilize IP / 12E for afterhours PK draws for patients transferring from the cancer center after 7pm on the weekdays or anytime during the weekends?

Yes No If yes, total # of PK draws needed?

4. Overview of Protocol Specific Requirements

(To check box, double click on box and change default value to checked)

4.1 Nurse Practitioner

Contact Elizabeth Allyn, MS, FNP-BC at: : 720-848-6247

ScreeningIP Visits OP Visits

History and Physical

Consult

Exercise Testing

ECG Interpretation

4.2 Inpatient and Outpatient Nursing

ContactDr. Joni Donahoo, ANP-BC/GNP, DNP at: : 720-848-7929

ScreeningIP Visits OP Visits

Phlebotomy

RMR

IVGTT

Drug InfusionsIf yes, oral or IV?

Drug Injections

ChemotherapyIf yes, how many chemo drugs?

Pharmacokinetics Blood DrawsIf yes, how many time points?

Urine Pregnancy If yes, who will supply the kits?

Electrocardiograms (ECG’s)If yes, single or triplicate?

CTRC machine or sponsors?

4.3 Core Laboratory

Contact Kayla Carstens, MT(ASCP) at: : 720-848-6877

Laboratory Processing of Samples

Laboratory Storage of Samples

Laboratory Assays

4.4 Exercise Balance Lab

Contact Jere Hamilton, BA at : 720-848-6375

Dexa Scan

4.5Core Echocardiography Laboratory

Contact James Thorpe, at: : 720-848-6686

EchocardiographIf yes, reference protocol page #

Echo Read by CTO Cardiologist

4.6 Nutrition Core Services:

Contact: Dr. Janine Higgins at:; 720-777-2955

4.6.1 Does your protocol require any of the following Nutrition services?

Check ALL that apply-

Regular CTO menu-based meals/ snacks (must complete section A)

Standardized or Nutrient -controlled meals (must complete sectionA and B)

Other. Please specify:

No nutrition services needed (skip this section)

A. If you are requesting ANY foods or beverages, please answer the following:

Are any outpatient meals to be served? / Yes / No / If yes, which meals?
Are any inpatient meals to be served (AIP)? / Yes / No / If yes, which meals?
Are any meals time- sensitive? / Yes / No / Please specify meals and times
Are these meals restricted for caffeine? / Yes / No
Do leftover foods/ drink need to be weighed back? / Yes / No

B. If you are requesting for standardized meals, please answer the following

Which of the following will be controlled in the diet:
Calories- Amount / Carbohydrates- amount / ratio
Fat -- Amount / ratio / Sugar -- Amount / ratio
Protein – Amount / ratio / Other : specify-

4.7 Miscellaneous Questions required for approval:

4.7.1 Will patients be seen in the clinic for all study visits pertaining to the protocol? YesNo If no, please list which study visits we will see patients in the CTO clinic and reference the page number of the protocol that describes these visits.

4.7.2 Who is responsible for dispending the drug?

4.7.3Will there be visits with long PK days?YesNo

4.7.4 What supplies will be provided by the sponsor?

Thank you for completing this form.

For further CTO Submission Guidelines please visit our website:

Page 1 of 4

COMIRB Attachment W for UCH Clinical Trials Office (CTO) Utilization Form

F-111, Revision 003, Effective Date 03/01/2012