APPLICATION PROCEDURES

Pre-Award

PreventionCenter staffs are available to offer information on intervention design and assist investigators in the preparation of grant application budgets. This service is limited to that aspect of the prospective study intervention involving PreventionCenter facility or service use. Each facility manager determines the breadth and length of assistance and may inform the study investigator that extensive or certain support may incur consultant service charges. Special consideration for the waiver of customary cost may be given to fellows and affiliate investigators who are making application for pilot studies.

PC staff understands that grant applications often have a tight deadline and the investigator needs ample time to prepare a proposal that will secure the highest possible score for award consideration. The complexity of some protocols requires that a number of factors are considered for PC service provisions. Given these two conditions, the PC should be contacted at the earliest opportunity if this resource will be important to intervention activities.

Initiation

  1. Contact the Administrative Manager of the PreventionCenter about the possibility of using PC resources in a project’s intervention activities. Disclosing the type of study and intervention proposed (feeding study, physical activity study, or clinical research) is important to this discussion.
  2. Often times a focused intervention will have activities and/or measures to be conducted by more than one resource. (E.g. a feeding study may require a blood draw at one or more timepoints, which involves two PC resource facilities.) Make certain that all potential resource activities are disclosed so that all parties necessary to any scheduled meetings may be invited.
  3. The Administrative Manager will provide the names and contact information of the facility managers who should be involved in further discussions about the study application. A meeting will be proposed so the study investigator and/or contact should have meeting dates and times in mind for this event when they contact the PC.
  4. We recommend that study staff share grant application document(s) with the PC so that staff members are fully prepared for any meeting discussions and can offer suggestions for services or intervention design specific to the protocol to help strengthen the grant application.
  5. Schedule a meeting with the identified resource manager(s) whose services or facilities will be integral to the proposed study protocol. To assure this meeting will bear fruit, it is advisable that you have determined all the proposed protocol activities and measures to be taken.

Activity

  1. The time invested by PC staff in pre-award meetings is generally at no cost to client studies. However, these services may incur costs depending on the frequency, length of meetings and depth of informationrequested.

Application Procedures- 1 -7/2011 v.1

  1. Staff will assist with resource specific research, forms development and offer any document templates which may be relevant to protocol design. Any such activity will be tracked for time invested and description of effort for study reference.
  2. The most important element of pre-award assistance is often the cost* estimate for requested resource services. This figure will often be the cost on which much of the proposed study budget will be built; however the quoted costs are only in effect for 12 months from the date of delivery. To facilitate an accurate quote the study must provide as much detail as possible regarding:
  3. Anticipated enrollment number
  4. Anticipated intervention participant number
  5. Number of intervention timepoints
  6. Which PC resources to be used for the intervention (Research Clinic (RC), Human Nutrition Lab (HNL), Exercise Research Center (ERC))
  7. Whether Prevention Center request will be for services (PC staff conduct intervention measures) or facilities use (study staff use PC resource facilities to conduct on-site intervention measures) or a combination
  8. Procedures to be conducted at each timepoint
  9. Supplies to be purchased for the conduct of procedures and measures
  10. If blood draws – ml measure for each draw and type of draw (phlebotomy, serial in-line, etc.)
  11. If specimen processing –type of specimen to be collected and number of aliquots for each ppt/timepoint
  12. Whether PC produced labels will be required for specimen and forms and number for each tube, aliquot and document per ppt/timepoint

Post-Award

On occasion PreventionCenter staff is not notified of an investigator’s intent to use services until after a grant or contract has been awarded. We will try to work within a study’s budget constraints to provide optimal services, provided service delivery does not place the PC in a deficit position.

Initiation

Initiation of PC services or facility use will be the same as steps 1 through 5 under Pre-Award. It is expected that a study already awarded will have the study design already fully developed and the intervention plan mapped with flow and measures determined.

  1. In addition to knowing which PC services (or use) are desired in the conduct of intervention activities, it is important to know a timeline for recruitment, enrollment and intervention implementation.
  2. Contact the PC administrative manager to schedule ajoint meeting with PC resource managers whose resource services are important to the intervention activities.
  3. Forward copies of research design and requested services to the appropriate managers in anticipation of the scheduled meeting.

Activity

  1. The exploratory meeting (usually 1 to 2 hours) is at no cost to the client study. Subsequent activities involving PC staff to determine service delivery may incur costs depending on level of PC involvement.
  2. Any consulting toward or actual development activities performed by PC staff (e.g. forms design, intervention flow, specimen collection and boxing for assays, etc.) will be tracked and included in start up costs.
  3. All components in 8 above under Pre-Award are required to determine cost estimate for Post-Award studies.
  4. At the delivery of the quote for services a final meeting should be scheduled to discuss feasibility of conducting intervention activities in the PC at the quoted costs. Client should be prepared to address which elements of the intervention measures can be conducted by study staff to reduce costs. (Facility room use costs may apply.)
  5. At the acceptance of the PC cost estimate the client must make application for the use of PC services and/or facility use. (This activity can be started prior to finalizing of cost estimate.) The application must be submitted (electronic copies) with the following documents:
  6. PreventionCenter application – must be signed by the study PI. The use of ExerciseResearchCenter or Research Clinic services also requires the signature of the study attending physician (whether or not procedures require physician participation). A signed hard copy must be delivered if an electronic signature is not available to append to the electronic copy document.
  7. If study staff will be using PC facilities to conduct measures, the names, titles, role and contact information for those staff must be included in the application.
  8. Depending on the tasks and the type of measures to be conducted the study will be required to provide copies of required certifications for certain performance activities.
  9. All questions on the application must be fully answered; cut and paste from another document is okay (do not reference an attached document with see attached as a response).
  10. Consent form(s) – a finalized copy of each IRB-approved consent form (must be updated for PC files with each modification)[Note, if the PC Oversight Committee notices that consent form language does not correctly state procedures or risks associated with PC activities, it may require the study to revise the consent form. Therefore we recommend that studies ask PC staff for model language to describe PC activities and risk before they submit their IRB applications.]
  11. Protocol – The study protocol with the specific aims, study design and aspects of intervention involving PC service or facility use highlighted.
  12. Copy of IRB approval cover page (participant appointments cannot be scheduled or study activities begun until this document is on file in the PC).
  13. Application and all supporting materials are sent to the PC Oversight Committee for review and determination of PC appropriateness for services. The review process usually takes 2 to 4 weeks.
  14. After Oversight Committee approval of the study application a fee agreement consistent with the cost estimate will be drafted for signature as the final step in the application process.
  15. A signed fee agreement and assigned budget number (or purchase order number) are required before services can be delivered. Up to an additional 4 weeks may be required before the PC is ready to receive study volunteers.
  16. Consortium or External applications may require additional documentation or extended application review time for approval of PC services or use.

*Rates and costs for PreventionCenter services and use are based on the status of the application, affiliation of the study PI and funding steward. The table below shows the three tiers of resource billing associated with a study application.

SCCA Category / Status Description
Internal / Rates for studies with a FHCRC full faculty member as Principal Investigator of the applicant study. Affiliate or associate members who are PI may qualify for this rate if FHCRC faculty serves as co-investigator and budget funds are administered through FHCRC grants and contracts office.
Fellows and junior investigators that have limited resources for pilot studies may qualify for this rate. FHCRC faculty must be listed as a co-investigator or lend mentor support to their application.
Consortium / PIs of Affiliate member organizations (UW, SCCA, Children’s Medical Center, Swedish, etc.) are eligible for this rate with consortium membership. FHCRC affiliate and associate faculty are afforded this rate if grant funds are administered through an affiliate organization and a full faculty member serves as co-investigator.
External / External applicants without an affiliate relationship to FHCRC are sometimes accepted depending on staffing and facility capacity. Rates for service to such organizations are at twice the internal rate.

Application Procedures- 1 -7/2011 v.1