CCSG Site Visits: Are You Ever Ready

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CCSG Site Visits Are You Ever Ready?

• Cancer Center Administrators Forum
• March 2008
• Presented by
• Lauren E. Hackett, MPAExecutive Director for
  Administration of the NYU Cancer Institute
• Anita L. Harrison, MPAAssociate Director of
  Administration, Hollings Cancer Center, Medical
  University of South Carolina

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Where is Anita Harrison? MUSCs first P30 CCSG
due May 2008
May 25th
Shared Resources
Biosketches
Programs
Essential Characteristics
Budget
PRMS
Cancer Center Administrator Sisyphus
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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

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Today

• AGENDA
• Advice 1 Dont Wait Plan Your Planning
• Advice 2 Administrative Review
• Advice 3 Core Facilities
• Advice 4 Unwritten Expectations

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Advice 1 Dont Wait Plan Your Planning

• Ideally Dont 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)

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Advice 1 Dont 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)

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Expenses

• Poster printing and graphic design
• www.makesigns.com (_at_ 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)

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Expenses

• 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

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Space

• 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
  andlap 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

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Space Set Up

• Most common complaint at site visits
  TEMPERATUREAlert 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.

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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 dont
  force it if a presenter has an exciting
  scientific slide to show that does not work well
  in the templateturn the background off avoid
  crowding slides limit animation

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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

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Advice 2 Administrative Review

• Following Directors 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 Centers budget total
  Center budget for most recent FY and all sources
  of support (pie charts helpful in conveying this
  info)

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Advice 2 Administrative Review

• A. Harrison typically looks for how
  Administration supports Centers research efforts
  (similar to that of any shared resource)
• How does staff administration participate in
  Centers 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?

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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

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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 dont
  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)

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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 write-up/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

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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

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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)

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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

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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 Centers
  entire clinical trials effort but does not
  include tasks involved in the actual direct
  conduct of individual trials.

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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

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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!!

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