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, approved IRB cover, and copy of approved consent form(s) to .
Questions regarding this application, and one signed paper copy of the completed application, should be addressed to
Jo Ann Henderson, (206) 667-2471.
Prevention Center Administrative Manager
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North, ME-B143
Seattle, WA 98109-1024
PRINCIPAL INVESTIGATOR INFORMATION
Investigator is a: FHCRC Internal Applicant Consortium Member ApplicantNon-Consortium Applicant
Please note that external users will incur applicable FHCRC Facilities and Administration costs.
STUDY INFORMATION
Research Project TitleIR # / 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 signature is required for studies usingPrevention CenterExercise Research Center or Research Clinic services whether performed by study or Prevention Center staff except where Director serves as study Co-Investigator.]
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
- Study Summary (provide background and rationale for study activities)
- Study Objectives (specific aims of study outcomes)
- Inclusive years of the study
- Indicate whether facility use is for:
Pilot Study Clinical Trial or Intervention Study Observational Study
- In sequence, list a brief description of procedures that will be followed in this activity/protocol
RESEARCH PARTICIPANT PROFILE
EnrollmentAgeRange / Number Males / Number Females
Adults Age 18-64
Age 65+
Minors Age 12 and under
Age 13-17
- Will procedures performed by PreventionCenter staff be performed on subjects identified as minors in your research study?
Yes No
- 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:
- Are procedures to be performed on study participants identified as medical treatment?
Yes No
If yes, please explain:
RESEARCH PROCEDURES
- 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 ClinicExam 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 byVital 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 facility use only:Approximate Use Start Date / Approximate Use End Date
Research Kitchen (e.g. dry/freezer storage)
Dining Room
Cooking Demonstration Station / Days and Times of Use (e.g. M-F, M-W-F; 8-10am, mornings)
Days: Times:
Frequency of Use (times per wk/mo)
Human Nutrition Laboratory staff and facility use:
Controlled Feeding study:
HNL provides all meals and beverages with predetermined nutrient contents or monitors ad lib intake for a specified number of days for each participant.
Approximate Use Start Date / Approximate Use End Date
Number of participants: / Number of study days per participant:
Number of different diets/feeding periods:
Meals to be provided:
Breakfast AM snack
Lunch PM snack
Dinner HS snack
Other (please describe) / Will any meals be eaten on site in the HNL dining room? No Yes
If yes, number of meals per week per participant:
Food pick-up/food delivery: Number of times per week per participant:
Controlled Meal study:
HNL provides some meals and beverages with a specific nutrient content or monitors ad lib intake for a specific number of visits for each participant.
Approximate Use Start Date / Approximate Use End Date
Number of participants: / Number of visits per participant:
Number of different diets/feeding periods:
Meals to be provided:
Breakfast AM snack
Lunch PM snack
Dinner HS snack
Other(please describe) / Will any meals be eaten on site in the HNL dining room? No Yes
Please give an estimate of frequency/meal intervals/total number of visits per participant: (e.g.1 meal every 2 weeks for a total of 3 visits)
Nutrient specific beverage or food item:
HNL provides a beverage or food item with a specific nutrient content or food for a specific number of visits for each participant
Number of participants:Number of visits per participant:
Brief description of study beverage or food item: / Please give an estimate of frequency/study intervals/total number of visits per participant: (e.g.1 study beverage every 2 weeks for a total of 3 visits)
Snack:
HNL provides a snack of unspecified nutrient content to study participants after specific study visits. Snack content to be determined later but may include either hot or cold beverage and a choice of homemade baked item.
Number of participants: Number of visits per participant:
Additional HNL services to be provided include:
Complete study diet design (includes diet calculations, menu development, recipe testing, and production design)
Diet production design (menu, recipes and diet calculations completed by client, HNL to develop production and
service/delivery procedures and documentation)
Meal service
Study participant management/monitoring
Nutrition education / food record documentation
Other(please describe)
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 to conduct study measures 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 study 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
Vo2
Non-Vo2
Indirect Calorimetry
Spirometry
Exercise Testing (1-RM, 6-min walk, etc.)
Recumbent Bikes
Treadmill
Elliptical Trainers
Strength Training Equipment
Chest Press Leg Press
Row/Rear Delt. Leg Curl Lat Pulldown
Leg Extension
Multi-purpose room / Days and Times of Use(e.g. M-F, M-W-F; 8-10am)
Days:
Times:
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 / TotalExercise Facility
Research Clinic
Human Nutrition Lab
Total Visits
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 / MailstopSTUDY 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
Radiation Risk Statement
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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