The FHCRC Prevention Center Clinic Has Space Available to Provide As a Clinical Site Where

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 [email protected].

Questions regarding this application, and one signed paper copy of the completed application, should be addressed to: Tara Ohrazda, 206-667-4639 Prevention Center Administrator 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 Applicant Non-Consortium Applicant

Please note that 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 FHCRC Prevention Center. 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 using Prevention Center Exercise 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 FHCRC Prevention Center 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

Prevention Center · 1100 Fairview Ave. No., Seattle, WA · 206-667-5416 · [email protected]

0b1deecdca346e1b00dd664204277f0a.docx page 1 of 10 STUDY SUMMARY

1. Study Summary (provide background and rationale for study activities)

2. Study Objectives (specific aims of study outcomes)

3. Inclusive years of the study

4. Indicate whether facility use is for: Pilot Study Clinical Trial or Intervention Study Observational Study

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

RESEARCH PARTICIPANT PROFILE

Enrollment

Age Range Number Males Number Females

Adults Age 18-64 Age 65+

Minors Age 12 and under Age 13-17

6. Will procedures performed by Prevention Center staff be performed on subjects identified as minors in your research study? Yes No

7. The Prevention Center 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:

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

Yes No If yes, please explain:

0b1deecdca346e1b00dd664204277f0a.docx page 2 of 10 0b1deecdca346e1b00dd664204277f0a.docx page 3 of 10 RESEARCH PROCEDURES

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

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 Prevention Center. Procedure and description Performed by Procedure and description Performed by Vital Signs PC Staff Anthropometrics PC Staff Study Staff Study Staff

Blood Draws (venipuncture) PC Staff Blood Processing PC Staff Study Staff Study Staff

Plasma/Serum Storage PC Staff Urine Collections PC Staff Study Staff Study Staff

Urine Processing PC Staff Urine Storage PC Staff Study Staff Study Staff

Other biospecimen collection (including PC Staff Other processing/storage PC Staff biopsies) Study Staff Study Staff

Medication administration (includes local PC Staff Any other anticipated clinical PC Staff anesthetic for biopsies) Study Staff needs Study Staff

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

Signature Date

0b1deecdca346e1b00dd664204277f0a.docx page 4 of 10 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 Prevention Center.

Human Nutrition Laboratory facility use only:

Approximate Use Start Date Approximate Use End Date Research Kitchen (e.g. dry/freezer storage) Days and Times of Use (e.g. M-F, M-W-F; 8-10am, mornings) Dining Room Days: Times: Frequency of Use (times per wk/mo) Cooking Demonstration Station

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: Will any meals be eaten on site in the HNL dining room? Meals to be provided: No Yes Breakfast AM snack If yes, number of meals per week per participant: Lunch PM snack Food pick-up/food delivery: Number of times per week per Dinner HS snack participant:

Other (please describe) 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: Will any meals be eaten on site in the HNL dining room? Meals to be provided: No Yes Breakfast AM snack Please give an estimate of frequency/meal intervals/total number of visits per participant: (e.g.1 meal every 2 Lunch PM snack weeks for a total of 3 visits) Dinner HS snack Other (please describe) 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:

0b1deecdca346e1b00dd664204277f0a.docx page 5 of 10 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.

Exercise Research Center (check all that apply and fill in Days and Times of Use (e.g. M-F, M-W-F; 8-10am) blanks; use separate sheet if necessary) Days: Treadmill Testing Times: Max (On site MD study staff required for ECG interpretation) Frequency of Use (times per wk/mo) Submax (Off site MD study staff required for ECG interpretation) Use is for: Vo2 One time use Non-Vo2 less than 6 months Indirect Calorimetry 6 to 12 months Spirometry 13-24 months Exercise Testing (1-RM, 6-min walk, etc.) greater than 24 months Recumbent Bikes Approximate Use Start Date Treadmill Elliptical Trainers Approximate Use End Date Strength Training Equipment Chest Press Leg Press Row/Rear Delt. Leg Curl Lat Pulldown Leg Extension

Multi-purpose room

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

0b1deecdca346e1b00dd664204277f0a.docx page 6 of 10 Signature Date

SUMMARY OF REQUESTED PC UTILIZATION

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

Year 1 Year 2 Year 3 Year 4 Year 5 Total Exercise 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 Prevention Center facilities (include additional page, if necessary).

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

STUDY PERSONNEL For any staff that will be conducting procedures on study participants in the Prevention Center 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

0b1deecdca346e1b00dd664204277f0a.docx page 7 of 10 0b1deecdca346e1b00dd664204277f0a.docx page 8 of 10 ADMINSTRATION OF DRUGS, INVESTIGATIONAL NEW DRUGS, AND BIOLOGICS

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

Yes No

Will procedures performed by Prevention Center 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 the intended 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.

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. Prevention Center pharmaceutical storage is not temperature regulated.

0b1deecdca346e1b00dd664204277f0a.docx page 9 of 10 CHECKLIST

The following documents are required as part of the application submission for use of any Prevention Center facility. Please check whether each item is attached, 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. ______

Attached Pending Submitted 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:

______Prevention Center Director Date

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