PREVENTION CENTER APPLICATION

It is required that applicants meet with the appropriate Prevention Center Managers to discuss specifics of your service request prior to completion and submission of this application. Please email this application, along with an electronic version of the protocol to .

Questions regarding this application, and one paper copy of the completed application, should be addressed to

Jo Ann Henderson, (206) 667-2471.

PreventionCenter Administrative Manager

FredHutchinsonCancerResearchCenter

1100 Fairview Avenue North, ME-B143

Seattle, WA 98109-1024.

PRINCIPAL INVESTIGATOR INFORMATION

Investigator is a: FHCRC Internal Applicant Consortium Member Applicant
Non-Consortium Applicant
Please note that external users will incur applicable FHCRC Facilities and Administration costs.

STUDY INFORMATION

Research Project Title
IR # / FHCRC Project ID
Division / Department
Principal Investigator / Mailbox / Phone
Contact / Mailbox / Phone
Principal Investigator Signature and Assurance
By signature (required) the study investigator certifies the accuracy, completeness and legitimacy of all statements contained in this application for use of the FHCRCPreventionCenter. By extension, the Principal Investigator agrees to accept responsibility for the conduct of intervention staff in execution of the study protocol and will provide information and documentation as required.
Signature Date
Attending MD (WA state Licensed) Signature and Assurance (if not study PI) [Note: this is not required for studies carried out by PreventionCenter staff.]
By signature (required) the study MD certifies review of this application for use of the FHCRCPreventionCenter and agrees to supervise and accept responsibility for the medical conduct and protection of human subjects in execution of the protocol by study staff.
Signature Date

STUDY SUMMARY

  1. Study Summary (provide background and rationale for study activities – or append IRB application)
  1. Study Objectives (specific aims of study outcomes – or append IRB application)
  1. Inclusive years of the study
  2. Indicate whether facility use is for:

Pilot Study Clinical Trial or Intervention Study Observational Study

  1. In sequence, list a brief description of procedures that will be followed in this activity/protocol

RESEARCH PARTICIPANT PROFILE

Enrollment
AgeRange / Number Males / Number Females
Adults Age 18-64
Age 65+
Minors Age 12 and under
Age 13-17
  1. Will procedures performed by PreventionCenter staff be performed on subjects identified as minors in your research study?

Yes No

  1. The PreventionCenter is available to research studies performing procedures on normally healthy participants. Are subjects on which intervention procedures will be performed classified as healthy? Yes No

If no, please explain:

  1. Are procedures to be performed on study participants identified as medical treatment?

Yes No

If yes, please explain:

RESEARCH PROCEDURES

  1. Is FHCRC listed as a performance site in your grant application? Yes No

If yes, please make certain to complete and attach an IRB Authorization Agreement to this application. [Note: see instructions for sentence to include in consent forms.]

RESEARCH CLINIC

FACILITY RESOURCE REQUEST

Research Clinic
Exam Room
Blood Draw Room
Medical Dispensary
Interview Room
Classroom
Auxiliary Lab / Number of Rooms (if applicable)
Approximate Use Start Date
Approximate Use End Date

RESEARCH CLINIC

SERVICE REQUEST

Please meet with Clinic Manager before completing this section. Prepare to provide details and fully describe clinical procedures required by the protocol which will be performed in the PreventionCenter.

Procedure and description / Performed by / Procedure and description / Performed by
Vital Signs / PC Staff Study Staff / Anthropometrics / PC Staff Study Staff
Blood Draws (venipuncture) / PC Staff Study Staff / Blood Processing / PC Staff Study Staff
Plasma/Serum Storage / PC Staff Study Staff / Urine Collections / PC Staff Study Staff
Urine Processing / PC Staff Study Staff / Urine Storage / PC Staff Study Staff
Other biospecimen collection (including biopsies) / PC Staff Study Staff / Other processing/storage / PC Staff Study Staff
Medication administration (includes local anesthetic for biopsies) / PC Staff Study Staff / Any other anticipated clinical needs / PC Staff Study Staff

If you are requesting use of the Clinic please obtain the signature of thePrevention Center Clinic Manager

Signature Date

HUMAN NUTRITION LAB

FACILITY RESOURCE OR SERVICE REQUEST

Please meet with Human Nutrition Lab Manager before completing this section. Prepare to provide details and fully describe those procedures required by the protocol which will be performed in the PreventionCenter.

Human Nutrition Laboratory
Research Kitchen
Dining Room
Cooking Demonstration Station
Days and Times of Use
Frequency of Use (times per wk/mo) / Use is for:
One time use
less than 6 months
6 to 12 months
13-24 months
greater than 24 months
Approximate Use Start Date
Approximate Use End Date

If you are requesting use of the Human Nutrition Lab please obtain the signature of the HNL Manager

Signature Date

EXERCISE FACILITY

FACILITY RESOURCE OR SERVICE REQUEST

Please meet with Exercise Facility Manager before completing this section. Prepare to provide details and fully describe testing and training procedures in study protocol. Staff utilizing the Exercise Facility must be credentialed as an ACSM Certified Personal Trainer, ACSM Health/Fitness Instructor, or American Council on Exercise Certified Personal Trainer. For exercise testing, the Exercise Facility Manager must receive a copy of each participant’s complete medical history and emergency contact information at least 24 hours prior to their scheduled appointment.

ExerciseResearchCenter(check all that apply and fill in blanks; use separate sheet if necessary)
Treadmill Testing
Max
Submax
Recumbent Bikes
Treadmill
Elliptical Trainers
Strength Training Equipment
sessions per week
hours per week/session
# participants
Multi-purpose room / Days and Times of Use
Frequency of Use (times per wk/mo)
Use is for:
One time use
less than 6 months
6 to 12 months
13-24 months
greater than 24 months
Approximate Use Start Date
Approximate Use End Date

If you are requesting use of the Exercise Facility please obtain the signature of the Exercise Facility Manager

Signature Date

SUMMARY OF REQUESTED PC UTILIZATION

Inclusive Utilization: list number of procedures to be performed annually by PreventionCenter staff for all years of the study (include additional page, if necessary)

Year 1 / Year 2 / Year 3 / Year 4 / Year 5 / Total
Total Number of Visits
Ambulatory Clinic
Feeding Studies Facility
Exercise Facility

STUDY PERSONNEL

Provide information about any staff who will be conducting procedures on study participants in the PreventionCenter facilities (include additional page, if necessary).

Name, title, employee ID / Role / Department/Division / Phone / email / Mailstop

STUDY PERSONNEL

For any staff who will be conducting procedures on study participants in the PreventionCenter facilities the following documentation is required. Please attach documentation.

MD Monitoring Exercise testing: ACLS

Exercise Specialists: ACSM ACE

Human Nutrition Lab: Food Handler’s Permit

Clinic: RN Blood born pathogens

PA WA State DOH Healthcare Assistant

All staff: CPR-AED HIPPA

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ADMINSTRATION OF DRUGS, INVESTIGATIONAL NEW DRUGS, AND BIOLOGICS

Will procedures performed by PreventionCenter staff be administered to participants who are in a treatment intervention?

Yes No

Will procedures performed by PreventionCenter staff require the administration

of therapeutic drugs or biologics?

Yes No

Will an investigational drug or biologic be used in the study?

Yes No

Will the pharmaceuticals be stored in and dispensed from the Prevention Center Dispensary?

Yes No

Please list the names and relevant information about those drugs, under what conditions those drugs would be administered, and the administration regimen, or attach the relevant section from your IRB application.

Indicate the approval status of the test article/drug:

Approved for the intended application

Approved but not for theintended application

If IND not required, please explain:

If IND is required, IND #

Phase I Phase II Phase III

Who holds the IND for this drug?

A copy of the FDA-IND letter is required. Please attach the letter to this application nor send a copy to the PreventionCenter office prior to application review by the Oversight Committee

Has the Food and Drug Administration withheld or restricted use of this test article/drug?

Yes No

Please note: The Prevention Center will perform as a storage facility but does not provide management and tracking of study medications. PreventionCenter pharmaceutical storage is not temperature regulated.

CHECKLIST

The following documents are required as part of the application submission for use of any PreventionCenter facility. Please check whether those items are attached to this application, pending, or whether they are currently on file as part of a prior application request. If previously submitted, please identify the study, funding agency, grant number and IR # under which they were previously approved. ______

______

AttachedPendingSubmitted N/A

Staff contact and employee ID

Certification of staff clinical training/education

Current IRB Review Approval

IRB Authorization Agreement (consortium apps only)

Protocol Summary

Consent Forms

Assent Forms (minors age 7-13)

FDA-IND Letter

OFFICE USE

Date Submitted for OC Review

Yes No

Reviewed

Returned for Completion

Approved

Date Approved

Comments:

______

Oversight Committee ChairDatePreventionCenter DirectorDate

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