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					CCSG Site Visits: Are You Ever Ready?

Cancer Center Administrators’ Forum March 2008
Presented by:

Lauren E. Hackett, MPA Executive Director for Administration of the NYU Cancer Institute Lynda Jacobsen, MPA Director of Administration, UCSF Helen Diller Family Comprehensive Cancer Center

Where is Anita Harrison? MUSC’s first P30 CCSG due May 2008

Cancer Center Administrator “Sisyphus”

Our Collected Experience
 A. Harrison: - 15 CCSG site visits as a reviewer for NCI - Assoc. Director of Administrator at Washington University for 1st P30 in ’01  L. Hackett: - 2 Successful CCSG reviews - 17 years academic medical center administration (10 w/ Cancer Centers) - New Reviewer for NCI

AGENDA: 1. Advice #1: Don’t Wait: Plan Your Planning 2. Advice #2: Administrative Review

3. Advice #3: Core Facilities
4. Advice #4: Unwritten Expectations

Advice #1: Don’t Wait: Plan Your Planning
 Ideally: Don’t wait until the day after the CCSG submission to begin planning your site visit.  NCI will contact you before the written submission to begin identifying site visit dates and persons who would have conflicts of interest in reviewing your application - You will be asked to provide 5 possible dates over a 2 month period, and the dates should include Tues, Wed or Thurs dates (site visits are not held on Mon or Fri)

Advice #1: Don’t Wait: Plan Your Planning
 Consider the following well in advance: - Identify suitable space for site visit - Notify and block travel 2 months prior with Center and institutional leaders - Set dates for dress rehearsals, include EAB - Begin/finalize NIH biosketches for all membership - Begin review of meeting/retreat documentation - Set template for shared resource posters

- Identify and formalize contract with presentation coach (if you plan to use one)

 Poster printing and graphic design - (@ $60 per poster for printing) - Use a graphic designer to work with your Core Directors  Site visit notebook for each reviewer - Agenda, color copies of slides, small poster prints, etc  Meals/snack for all participants; feed membership during rehearsals  Transportation for site team to/from hotel and for tours to shared resources (if needed)

 Additional audiovisual (may be extra costs) - every 2-3 reviewers access to table top microphone - 2 podiums for speakers/leadership - access to power for laptops for site visitors
 Additional honoraria/travel for EAB members if they attend dress rehearsals  Presentation Coach – anywhere from $50 -100/hr

 Size of site visit team depends on size of Center; average site team is in the 20-25 person range  Room needs to be spacious enough to allow each reviewer plenty of “elbow” room (open binder and lap top, place for plate/drink)  Other designated seating areas needed for: - Senior Leadership - Other Center leaders/staff and institutional guests - Designated area for NCI staff (2-4 people) - Designated area for documentation (meeting minutes) - Adjacent room for Cancer Center staff coordination

Space: Set Up
 Most common complaint at site visits: TEMPERATURE Alert the facility manager about the site visit and know who to call to adjust temperature quickly. Test out ability to modulate temperature during dress rehearsal.  Seating - U shape is best layout for site visitors; prepare name tents for site visitors (and NCI staff) - Provide the most comfortable chairs for site visitors and NCI staff (they will be sitting all day!)  Remind everyone to turn off pagers, phones, etc.

The Opera
 Dress rehearsals – number depends on the experience of the institution/leadership; 2 is a bare minimum, 3-5 the norm Note: Dress rehearsals include rehearsing the room  To script or not to script - Advantage: easier to control time; ensures that the main points are made - Disadvantage: risk of putting reviewers to sleep - Cohesive Center: Consistency in message, language, programs, cores

 Slides should have a common template but don’t force it; if a presenter has an exciting scientific slide to show that does not work well in the template—turn the background off; avoid crowding slides; limit animation

Words of Wisdom from 15 Reviews
 Consider the gender balance of your site visit presentations; review team will likely be gender balanced and it is noticed when all presentations are made by men; note there is no NCI guidelines/policy on this – see unwritten expectations slide  Do all Senior Leadership have role in site visit?

 Coach presenters to not be defensive when questioned; if presenter fails to answer a question, Director needs to follow up on the question in his/her closing remarks
 Know your review team: Research your site visitors and share with leadership; help anticipate questions  Always a Plan B for presentations

Advice #2: Administrative Review
 Following Director’s first presentation, Administrator typically ―pulled out‖ for discussion with Administrative Reviewer (~one hour)  Typical data requests at this meeting driven from discussions the evening prior
     status of pending grants updated or missing biosketches updated or missing budget information clinical trial number discrepancies, etc. Clarifications on the Center’s budget: total Center budget for most recent FY and all sources of support (pie charts helpful in conveying this info)

Advice #2: Administrative Review
 A. Harrison typically looks for how Administration supports Center’s research efforts (similar to that of any shared resource)  How does staff administration participate in Center’s decision making, planning and evaluation processes?

 Does the administration have adequate IT systems in place to provide efficient and effective services? Demonstration of IT systems may be requested  How does administration foster development of research and research collaborations?

Advice #2: Administrative Review
 Materials on hand: - Strategic Plans - Policies: compliance, internal controls, finance, purchasing, space, membership, personnel - Handbooks for faculty, staff - Welcome to Cancer Center package - Business Plan templates - Recruitment templates

 Remember: entire day is a review of the strength of Administration

Advice #3: Core Facilities - Poster Session
 Poster data/info should match write up or be clearly labeled as updated - Core Director clearly articulates differences between write up and the poster - Be especially careful with clinical trial accrual numbers; reviewer red flag when numbers don’t match; carefully label reporting period and whether the numbers reflect therapeutic, non-therapeutic, or interventional  Present exciting science that was produced with the shared resource (largest portion of the poster)

Advice #3: Core Facilities - Poster Session
 Usage logs at the poster - Administration should review these logs prior to the site visit to ensure data is consistent and matches writeup/poster  Rehearse the Core Directors too! - Oftentimes Cores that are part of a larger University service are not as connected to the organization of the Cancer Center; make sure they are knowledgeable about the research programs and what exciting cancer research is ongoing  Outreach and Comprehensive work

Advice #3: Core Facilities - Tours
 Use experienced staff as escorts for tours: community outreach staff invaluable

 Tours to animal-related shared resources almost guaranteed
 Tours to Clinical Trials Office guaranteed - Reviewers typically ―quiz‖ staff to test whether unit that was described on paper is ―real‖ - Demonstration of IT system(s) supporting the clinical trials unit - How long does it take to open a study at the Center? - If clinical coordination of trials is ―decentralized‖, are their shared SOPs, standards, communications, any dual reporting authority

Advice #4: Unwritten Expectations
 The most difficult aspect in preparing for a CCSG site visit is not presenting the information as outlined by the written CCSG guidelines but the attempt to anticipate the unwritten expectations that each reviewer brings to the table. Unwritten expectations are based on: - Personal (good and bad) experiences one has had in their own Center - Comparisons to other Centers - CCSG guideline changes they think should be made or know that will be made in the future - Not having read the CCSG guidelines carefully and basing review on guidelines for other types of awards (SPORES, PPGs, other NIH Center grants)

Advice #4: Common Unwritten Expectations
 Research Strategic Plans - Page 15 of CCSG guidelines says ―Center does not have to provide a formal written strategic plan‖ - Nearly always someone wants to know if you have one and then, if they can see it

- Best to be upfront: - If you do not have one and are asked to outline plan, this should be a clue that site reviewers are not “hearing” what your future scientific directions are - Prompt for Director to address future directions or how and why the Center has taken the directions it has during final comments

Advice #4: Common Unwritten Expectations
 Clinical Trials Organization -- centralized vs. decentralized for clinical research coordination services - Guidelines say, ―resource must provide central management and oversight functions for coordinating, facilitating and reporting on trials‖ - Later on, the guidelines say, ―resource allows oversight and quality control for the Center’s entire clinical trials effort but does not include tasks involved in the actual direct conduct of individual trials.”

Advice #4: Unwritten Expectations - Clinical Trials
 Clarity: CTO is a repository of all trial information for the Center. You may have clinical trial study coordinators enrolling pts, scheduling study visits, entering data on CRFs, etc who are employed by other departments  There is a litany of effective organizational models for clinical trial services; remember: CCSG reviewers come to the table with strong opinions on what does and does not work based on their own experiences

 Many believe that 100% centralized clinical trial services is the best model

Advice #4: Unwritten Expectations - Clinical Trials

 If clinical trial accruals are not ―outstanding‖ (e.g., therapeutic accrual approximately 15% equivalent of your newly diagnosed patients), risk criticism for not having a completely centralized trial structure  Many discussions/debates regarding structure are had during site visits

 We need more clarification by the NCI Cancer Centers Branch on this topic!!

Cancer Center Sr. Leadership - Day After the P30 Grant is Submitted

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