orientation for new clinical research...
TRANSCRIPT
Orientation for New Clinical Research PERSONNEL
Module 4
• Presented by
• NC TraCS Institute• UNC Office of Clinical Trials
• UNC Network for Research Professionals
Overall Agenda for Orientation• Module 1:
Introduction to Clinical Research, Education, and IRB• Module 2:
Informed Consent, Documentation, GCP and Study start-up
• Module 3: Contracting, Billing Coverage Analysis, ClinicalTrials.gov, Essential Documents
• Module 4: Recruitment, Budgets and Accounting, Preparing NIH Grant Budgets, and IDS / Device Policy
• Module 5: COI, From CDA to Close Out
RECRUITMENT SERVICESCarol Breland, MPH, RRT, AE-CResearch Recruitment DirectorNC TraCS
NC TraCS Recruitment Services GoalsAccelerate Subject Recruitment across UNC!
Improve UNC research studies internet presenceo Provide a free engaging education website geared to the general
public to list studies https://jointheconquest.org/index.php/en/.• A simple research volunteer registration process• A easy to read studies listing geared to the general public• An online location for volunteers and UNC researchers to interface• Uses social media tools- Facebook, Twitter, etc.
Disseminate research recruitment tools and methodso Recruitment planning consultationso Tool kit for recruitment campaignso Researcher networkingo E-recruitment methodologieso Best practices workshops and presentations
https://tracs.unc.edu/index.php/services/recruitment-services
Is this your study recruitment plan?
Barriers to Study Recruitment• A recent poll was conducted by Zogby Analytics for Research
America • One question asked was “Fewer than 10% of Americans participate in
clinical trials. Why don’t people take part in research studies?”• Answers:
• Not aware/lack of information = 53%• Lack of trust = 53%• Too risky = 51%• Adverse health outcomes = 44%• Little or no monetary compensation = 35%• Privacy Issues = 27%• Too much time = 27%• Not sure = 11%
Recruitment Plan Considerations
Recruitment Tactics
Internal Resources External Outreach
Recruitment Strategies
Population Identification Population Availability
Protocol Feasibility
Facilitators BarriersVS
vs
vs
Recruitment Strategies
Identify your target population
Define your goals and timelines
Recruitment TacticsBefore you develop your promotional campaign materials, ask yourself:What message do you want to convey to potential volunteers about the study?
To promote your study, remember that each study requires a customized approach!
• Send an email, letter, postcard or call patients from approved registries or chart review
• Create posters, pamphlets, mailings (flyers, letters, post cards)
• Request a consult from the Carolina Data Warehouse for potentials from the EMR
• Develop a friendly and informative phone screen/script
• Build a study-specific website using Wordpress or consider StudyPages/other vendor
• Create a social networking outreach campaign- Facebook, Twitter, Instagram
• Attend Community events (fairs, flea markets, senior center health events)
• Develop a UNC mass email
• Consider mass media advertising - TV, radio, print
• List on ResearchMatch.org
• List on JointheConquest.org
Recruitment Tactics - continuedTactics that don’t require IRB approval:
• List your IRB approved study in Join the Conquest • Develop a system for identification of potential
subjects in your clinic• Attend conferences • Conduct informational lunch ‘n learns on the
condition you are studying• Arrange for presentations at departmental meetings
Recruitment Tactics – Dear Doctor Letters• Dear Doctor Letters – snail mail, fax or email to local providers
Our UNC IRB requires review of doctor to doctor letters as part of your recruitment plan. These types of communications are not seen by patients but inform providers about your study.
Note! Although our UNC IRB requires approval for doctor to doctor letters, FDA regulations are less stringent. UNC IRB will be revising their SOPs over the coming months and will take into consideration the FDA guidance.Learn more at:http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm
Reminder ! UNC IRB SOP 26.2 - “…prohibited are finder’s or referral fees to colleagues who may identify or refer eligible subjects to a research study (e.g., a general practitioner sending patients to a specialist conducting a study.)
Recruitment Planning TipsA recruitment plan should be developed as soon development begins on the protocol or as soon as you receive it, whether investigator-initiated, industry-sponsored, NIH or other sponsor.1. Start with a protocol review with a focus on recruitment
– inclusion/exclusion criteria, study procedures and timelines
2. Develop a subject profile and identify barriers and benefits to participation
3. Use i2b2 to estimate available population cohort counts
4. List your recruitment strategies – identify your population and goals
5. For each strategy, list your tactics – where, when, how you will contact potentials
6. Create a promotional campaign with timeline
7. Evaluate your plan for risks and develop contingencies
8. Develop a practical budget and estimate resource needs
9. Start slow, make adjustments and then increase your speed
10. Review your plan at least monthly or more often as needed
IRB approval of recruitment promotional materials is required!
What’s New in Recruitment Services?Now live! Join the Conquest upgrades:
• New template with homepage enhancements• Search studies without logging in (still need to
join to Contact the Researcher) • Search by special populations• Volunteer appreciation events
Coming soon!• Improved study listing form• Recruitment metrics • Provider access portal• Volunteer interest profile• Study search wizard
Where Can I Learn More About Recruitment Services?
Visit NC TraCS Recruitment Services Website
http://tracs.unc.edu/index.php/plan-research/research-recruitment
Drop by the Recruitment Services Pop Ups! 1-4 PM CTRC Rm # 1042Dates coming up: May 10, June 14, July 12
Call or email NC TraCS at [email protected] 919 966-6022
Contact Carol [email protected] 966-6274
RECRUITMENT THROUGH THE CDW-H: IRB REQUIREMENTSCarol Breland, MPH, RRT, AE-CResearch Recruitment DirectorNC TraCS
Carolina Data Warehouse (CDW-H)• What is the CDW-H:
• The CDW is a central data repository containing clinical, research and administrative data sourced from the UNC Health Care system.
• UNC Healthcare extended to Rex, Chatham, Pardee, etc. so with Epic introduced at these outlying hospitals, patient data flows into CDW
• What is included in the CDW:• All legacy Webcis data and now all Epic data• Includes medical, financial and other hospital data • For new hospitals now in UNC Healthcare (i.e., Rex
Hospital), this means their patient data is also in the CDW, if they are using Epic.
CDW and Research Recruitment• The CDW serves as a gatekeeper to providing research
teams with EMR data on patients who meet eligibility for recruitment.
• If recruiting through CDW, recognize that patient info provided could be for patients at many locations
• May want to narrow recruitment search to those in specific zip codes to avoid getting patients outside main UNC campus area (if so desired)
• If you want to recruit from other hospitals, consider whether there are other gatekeepers at outlying facilities who may need to be aware of your recruitment approach
Recruitment Etiquette• Old-fashioned courtesy is paramount!• Review carefully the list of potential participants provided
by CDW-H and exclude any that are not eligible• Engage any known providers in recruitment early in the
process- (Do you have patients that meet these criteria?) • Request a PCP contact from participants and send a letter
or email to alert them of trial participation • Affiliate hospitals and clinics new to the UNC research
mission require additional time to absorb recruitment methods developed for main campus- be patient!
• Promote trial opportunities as a benefit of being part of the UNCHCS provider network.
Indicating Use of CDW in IRB Application
• A.9 Identifiers: Mark all identifiers you will receive from CDW (names, telephone #s, dates or date of birth, zip code, email, medical record number). Must match CDW request form.
• B.1 Methods of Recruiting: Indicate use of a telephone script or recruitment letter to reach out to potential participants. IRB will require you submit the documents for approval.
• B.2.1 Request a Limited Waiver of HIPAA to identify potentially qualified subjects in order to contact them to elicit their interest in study.
• B.3.4 Where are you studying subjects: Indicate Healthcare setting and check places that apply (UNC medical center, Rex Hospital, Chatham Hospital, etc.) and specify where in the facility subjects will be studied (e.g., CTRC, ACC, Peds Clinic).
• C.1 Data Sources: Indicate use of UNC Health Care System Medical records, then check electronic medical records using CDW-H.
Recruitment LettersSuggested language:• Your records in the UNC Health Care System indicate you
may be eligible to participate in our research study entitled “Xxxxxxxxxx”. We are contacting people who have either an xxxx (lab value) or xxxx (specific inclusion criteria) …….
• We are contacting people who are in the xx to xx age range who have been seen by the UNC Health Care System in the past year in order to tell them about a research program that we are doing.
• We are contacting you because you were seen by UNC Health Care or one of our affiliate hospitals or clinics in the past year……
Telephone/Email ScriptsBegin with something similar to the recruitment letters:• Hello, my name is __________. I am a (student/faculty
member/staff member) from the University of North Carolina at Chapel Hill conducting a research study entitled XXXXXXXXX. This study will test xxxxx in xxxxx patients. Your records in the UNC Health Care System indicate you may be eligible to participate in our research study OR based on your medical history, you may be eligible to participate in our study.
• If participant asks “How did you get my name/contact information?”• Answer: We received approval to access medical records of patients
in the UNC Health Care System who meet our research study criteria. Based on your medical history, you appear eligible to participate in this study.
• If participant states, “but I am not a UNC Health Care patient, I go to Rex Hospital (or other hospital/clinic)”. • Answer: UNC Health Care System now includes several affiliate
hospitals and clinics, including Rex (or other).
What to say… and not to say• Language used in recruitment materials should only reference
or describe medical records coming from the UNC Health Care System and Affiliate Hospitals / Clinics.
• Subjects do NOT actually sign up for the Carolina Data Warehouse for Health. The names of potential research participants are in the CDW by virtue of them having been seen by the UNC Health Care System (includes affiliate Hospitals and Clinics) in the last few years.
• One should NEVER say “We are contacting you because you signed up with the Carolina Data Warehouse for Health” as this is incorrect.
• Recruitment letters / telephone scripts should NOT make a reference or describe that patient data or records were provided by the Carolina Data Warehouse for Health.
Contact for more information• Carol Breland, MPH, RRT, Research Recruitment
Director, NC TraCS [email protected]
• Marie Rape, RN, BSN, Associate Director of Regulatory, NC TraCS [email protected]
• Cat Collins, IRB Analyst ([email protected])
BUDGETING AND ACCOUNTING OF RESEARCH FUNDS Jillyan CunnupAdministrator, Division of Endocrinology
The Financial Struggle
Process of Building a Budget
Review most recent protocol
and study activity listings
(Protocol Feasibility)
Review Contract and
current budget (if provided)
Identify procedures
required and determine cost
List all other fees, direct and
indirect
Budget Development
• Clinical Trial Agreement • Start up and Advance payment
• When and How much?• Payment Cycle
• How often will they pay?• Withholding %
• How much are they going to hold back?• Length of Storage
• 10-20-30 years?• Final Payment
• Timing of Payment?
Billing Compliance and IRB Review Fees Invoiced by the Office of Clinical Trials
Industry-Funded Studies using a Central IRB
Industry-Funded Studies using UNC’s IRB
Initial IRB Review Fee N/A $3,000
Initial Preparation Fee $1,000 Included in above
IRB Renewal Fee N/A $750
IRB Fees (not subject to F&A) IRB fees invoiced by the Office of Clinical Trials.
IRB review fees shall be incurred upon IRB review, even if a study contract has not yet been executed. The IRB review fees are assessments for a portion of the real costs associated with protocol review and related study requirements by the IRB. The actual costs of the review process are still incurred if subjects are never enrolled, if the study terminates before milestones are met, if expenditures exceed revenue, or if a contract is never finalized. The invoice is therefore due and payable upon receipt. The investigator and/or department will be responsible for all costs not covered by the sponsor, specifically including the IRB (and BCA) review fees
Billing Compliance Fees• Billing Compliance (for conduct of BCA) fee (not subject to F&A)
BCA fees invoiced by the Office of Clinical Trials
• A fee of $2,000 will be charged to the sponsor as a Billing Compliance Fee to cover the cost of conducting a BCA, and should be included in budgets submitted to the sponsor as of March 1, 2014. This fee is incurred upon conduct of the BCA, even if a study contract has not yet been executed.
• The purpose of the BCA is to determine deemed and qualifying status as well as which routine care costs may be billed to Medicare or other insurers and which costs must be paid by the sponsor. The Billing Coverage Analysis is required to be performed prior to the initiation of the clinical trial to ensure proper billing of services and financial feasibility.
External Budget• Direct Costs
• Labs• EKG• CT Scans
• Effort Costs• Informed Consent- Creation of CF as well as consenting subject• Physical Exams, Vitals and History
• Coordinator and PI Time• Drug Dispensing • Review of Labs
• Coordinator and PI Time• Scheduling of Patients
• How long does it take to transport that patient for a CT Scan etc?• Recruitment• Monitor Visits
Effort Based CostsEffort Based Procedures
• Informed Consent• Physical Exams • Vitals and History• Drug Dispensing
PI and CRC Time• Review of Labs, Scheduling of patients, recruitment of
patients monitor visits etc.
F&A• Ensure correct University F&A rate is being applied
Invoiced Items• Start Up Fee• Advertising• Document Storage• Rent• Screen Fails• Adverse Events• FDA/Sponsor Audits• IRB/BCA Fee
• IRB Renewal• IDS• Dry Ice• Protocol Amendment
Facilities and Administration Rate
Activity On-Campus Off-Campus(10-mile radius)
Off-Campus (Remote)
Organized Research 52% 28.00% 26.00%
Instruction 50% 28.00% 26.00%
Other Sponsored Activities 36.% 28.00% 26.00%
Clinical Trials (Federal)** 52.00% 28.00% 26.00%
Clinical Trials (Non-Federal)*** 28.00% 28.00% 26.00%
Successful Negotiation
•What is negotiation?• Negotiation is the process of two parties or individuals reaching an agreement and actively participating in making decisions
•Successful Negotiation?• Succeeding means that you work with the other party to reach a
solution to the issue you are all happy with it does not mean viewing negotiation as a battle to be won!
Federally Funded BudgetsRFA-Request for Application
• All Federal Funded applications are linked to a RFA which details the requirements for the application.
SF424• Common packet used for NIH submissions will include budget, bio
sketches, research plans, science of grant etc. Salary Cap/Cost Share
• The current NIH Salary Cap is 185,100 anyone being paid from the grant making over that amount must have a cost shared effort.
• Cost Sharing is the portion of the project that is contributed by the University for example if you have a salary of 200,000 and are going to spend 10% of your efforts (20,000) you are only allowed to charge the grant for 10% of 185,100 (18,510) the difference must be charged to a University account and paid for by the University. Using this example you would need approval to cost share $1,490
Modular Budget Vs. Detailed BudgetModular Budget
• Used only in certain types of NIH applications provides a less detailed budget with a maximum of 25,000 per module (250,000 per project)
• Does NOT list out salary and fringe benefit rates though the salary cap does still apply
Detailed Budgets• Effort must be shown in Calendar months not % of effort
• (10% effort =1.20 calendar months) • Fringe Benefits • Senior/Key Personnel• Equipment• Travel• Publication • Other costs related to project• Maximum depends on the information in the RFA
Accounting of Research Funds• The tracking of research funds can make or break a
research project. This is often done by various people in the department but is crucial to success
Visits Payment Expenses
Visit Tracking• Industry Sponsored Trials
• Log of completed, skipped or incomplete visits• Track when data entry is completed per visit• Keep a log of each visit completed by the subject and
make note if certain parts of the visit were not completed or if a visit was skipped.
• Federal Funded• Tracking subject visits is equally important on a federal
funded studies. Depending on how the study is set you up may have already received a set amount based on the number of patients. If you fail to recruit or skip a visit you could end up paying back money at the end of the grant.
Patient Data Invoicing- Why and How?• Why should we invoice?
• To ensure ACCURATE payment of completed work. • To ensure TIMELY payment of completed work• To ensure QUALITY reconciliation can occur
• How do we invoice?• Send invoice to the sponsor with visit data• Send invoice to managers with visit data
Payment and Expenses• Checks
• Ensure checks are sent in a timely manner based upon contract• Always verify that the amount of money received matched the
amount of work completed.
• Expenses• Track procedure, patient payments, salary, supplies as well as
other study related costs.
Financial Compliance
Effort Certification and Reporting Technology • Effort is the portion of time spent on a given professional activity and expressed
as a percentage of the total 100% professional activity for which an individual is employed by UNC.
• Important points:• The government recognized that it is a “reasonable estimate”• Total effort must equal 100%• Effort is not based on a standard (e.g 40-hour) work week, instead based on
whatever was worked• 100% effort considers all professional activities related to the individual UNC
appointment. • Effort does not include outside activities (external consulting etc)
• Certifying Effort• Effort is certified on a regular basis via ecrt.unc.edu• All employees paid from sponsored activities are required to certify the effort
spent• Effort is calculated based on the information in the payroll system• The investigational item or service itself, unless otherwise covered outside the
clinical trial
Closing of Account• All money received?
• Make sure all visits, invoiced items,• Always verify that the amount of money received matched the amount
of work completed as well as the amount on the contract.
• Expenses• Verify IRB, IDS and other University expense have been paid. Often
with UNC bills are delayed and it is your responsibility to check this before closing a study.
• Residual Funds• If you have money leftover you will be allowed to transfer the funds
into a residual. Residual accounts are managed at the Department/Division level. You will need to be aware of what the policy is on spending and accountability. Federal funded grants will require written communication and approval from the NIH for carryover or no-cost extensions.
Preparing & Executing NIH Grant Budgets for Clinical Research Studies
Cassandra J. Barnhart, MPHManager of Research Administration
UNC Ophthalmology
Objectives
• Learn the differences in budget preparation between NIH vs. Industry sponsored trials
• Identifying resources and tools to assist in preparing your budget
• Identifying reasonable / hidden costs to your department (the NIH won’t pay for WHAT?!)
Federal vs. Industry: What’s the Difference?
Industry• Primary goal is FDA
approval to market a new drug or device (or a new indication)
• More common disease indications (for example, Type II diabetes)
Federal• Primary goal is to answer
“best practice” medical questions (comparing current therapies). Ratio benefits / risks
• More likely to conduct research on less common indications (for example, Type I diabetes)
Federal vs. Industry: What’s the Difference?
• Overhead
Activity UNC Facility
Non-UNCFacility (10-mile radius)
Non-UNCFacility
(Remote)
Organized Research 55.50% 28.00% 26.00%
Instruction 50.00% 28.00% 26.00%
Other Sponsored Activities 36.00% 28.00% 26.00%
Clinical Trials (Federal)* 55.50% 28.00% 26.00%
Clinical Trials (Non-Federal)** 28.00% 28.00% 26.00%
Federal vs. Industry: Salaries
Industry Sponsors
• No salary cap• Generally no direct salary
support (paid on a per-visit basis)
• Estimated hourly wage
Federal Funding
• NIH salary cap of $187,000• FTE for research staff
allowed (within reason)• Estimated “Calendar
Months (CM)”
Getting Started: Where to Begin?
• Funding Opportunity Announcement (FOA) on Grants.gov.• Search for grant opportunities
• Newest• Category• Agency• Eligibility
• Learn Grants (Grants 101) – recommended if you’re new to grants
• Download application packet (or use Cayuse)
Getting Started: Where to Begin?
• Cayuse 424• UNC’s grants processing system• Able to create a new proposal with FOA number found on
Grants.gov• Automatically loads required forms (less headache)
Getting Started: Where to Begin?
• Two types of NIH budgets
» Modular• $25,000 increments (up to $250,000/year in direct costs)• No detailed budget required* (only Personnel Justification)*OSR still requires a detailed budget
» Non-Modular• Typically available up to $500,000/year without prior approval
(dependent on award mechanism)• Detailed budget required for each year requested
Getting Started – Items to Consider
• Salary & Fringe» Principal Investigator
• Current salary cap is $187,000 (Per NIH - ask for full amount, but know that this is the max that will get funded – usually updated annually)
• If clinical faculty, must use Supplemental Rate (28.172% plus medical insurance stipend of $7,752.04)
• If basic researcher, use general rate of 23.093% plus medical insurance stipend of $5,659 (ask HR if unsure)
» Coordinator• Fringe benefit rate is 23.093% plus medical insurance stipend of $5,659
» Grad Student Research Assistant• Fringe benefit rate is 8.99% plus medical insurance stipend of $4,310• Tuition must also be covered, prorated to effort
» Okay to increase by 3-5% annuallyUpdated fringe benefit rates can be found at:
http://research.unc.edu/offices/sponsored-research/resources/data_res_osr_infosheet/
NIH Cost Principles (NIH Grants Policy Section 7.2)
• Is it Reasonable and Necessary?» A cost may be considered reasonable if the nature of the goods or
services acquired or applied and the associated dollar amount reflect the action that a prudent person would have taken under the circumstances prevailing when the decision to incur the cost was made.
• Is it Allocable?» A cost is allocable to a grant if it is incurred solely in order to
advance work under the grant; it benefits both the grant and other work of the institution, including other grant-supported projects; or it is necessary to the overall operation of the organization and is deemed to be assignable, at least in part, to the grant.
NIH Cost Principles (NIH Grants Policy Section 7.2)
• Is it Consistent?» Costs may be charged as either direct costs or F&A costs,
depending on their identifiable benefit to a particular project or program, but all costs must be treated consistently for all work of the organization under similar circumstances, regardless of the source of funding.
Examples of Allowable Direct Costs (NIH Grants Policy Section 7.9)
• Advertising and PR» Recruitment, program outreach
• Animals» Cost to purchase and maintain
• Child Care Costs » For research participants
• Consortium (Subcontract) Agreements» If subcontracting with another site to conduct study
• Study Drugs» Purchase costs
• Equipment» Specifically purchased for the study ($5,000 or more)
Examples of Allowable Direct Costs (NIH Grants Policy Section 7.9)
• Incentives» Research participant stipends
• Materials and Supplies» Specific to conduct of the study» May include computers
• Meals» For research participants (e.g. CTRC studies)» Okay if not already included in stipend
• Professional Services (Consultants)» Example is a Biostatistician not on salary at UNC» Flat rate, no fringe benefits
• Publication and Printing» Journal submissions of study results, etc.
Examples of Allowable Direct Costs (NIH Grants Policy Section 7.9)
• Research Patient Care» Anything with a CPT code» Not to exceed Medicare Allowable (NOT the research fee)» Labs» Exams
• Travel» Meetings specific to study or presentation of results at research
conference» Includes transportation, lodging, and per diem amounts
NIH Internal Budget Forms (Initial Period)
NIH Internal Budget Forms (Initial Period)
NIH Internal Budget Forms (Initial Period)
NIH Internal Budget Forms (Initial Period)
Indirect Costs
• Current Rate is 55.5% (unless otherwise indicated in grant announcement) of most allowable direct costs
• Includes: salary & fringe, materials & supplies, consultant fees, travel, publication costs, patient stipends, consortium costs up to $25,000 per entity
• Does NOT include: equipment, patient care costs, tuition, each consortium cost IN EXCESS OF $25,000 (total proposed period)» If any of these apply, specify Modified Total Direct Costs on
grant application
Example NIH Internal Budget
Grant Budget Worksheet Example5,659.00
PI non-MD1st yr full salary % fringe % increase/yr medical
90,000 0.2309 0.030 5,6592nd yr full salary 95,400 5,8293rd yr full salary 98,262 6,004
Y1 % salary Y2 % salary Y3 % salary0.800 0.800 0.800
initial budget 2nd yr 3rd yrsalary 72,000.00 76,320.00 78,609.60fringe+medical 21,154.16 22,287.59 22,956.22Total 93,154 98,608 101,566
PI MD1st yr full salary % fringe % increase/yr medical
168,273 0.2817 0.030 7,7522nd yr full salary 173,321 7,9853rd yr full salary 178,521 8,224
Y1 % salary Y2 % salary Y3 % salary0.200 0.200 0.200
initial budget 2nd yr 3rd yrsalary 33,654.60 34,664.20 35,704.20fringe+medical 11,031.57 11,362.51 11,703.41Total 44,686 46,027 47,408
Example NIH Internal Budget
MD w/Salary Cap 1st yr full salary % fringe % increase/yr medical185,100 0.2817 0.030 7,752
2nd yr full salary 185,100 7,9853rd yr full salary 185,100 8,224
Y1 % salary Y2 % salary Y3 % salary0.100 0.100 0.100
initial budget 2nd yr 3rd yrsalary 18,510.00 18,510.00 18,510.00fringe+medical 5,989.84 6,013.09 6,037.05Total 24,500 24,523 24,547
PostDoc 1st yr full salary % fringe % increase/yr medical55,000 0.0899 0.030 4,310
2nd yr full salary 56,650 4,4393rd yr full salary 58,350 4,572
Y1 % salary Y2 % salary Y3 % salary0.500 0.500 0.500
initial budget 2nd yr 3rd yrsalary 27,500.00 28,325.00 29,175.00fringe+medical 4,627.25 4,766.07 4,909.07Total 32,127 33,091 34,084
Coordinator 1 1st yr full salary % fringe % increase/yr medical61,763 0.2309 0.03 5,659
2nd yr full salary 63,616 5,8293rd yr full salary 65,524 6,004
1st yr % salary 2nd yr % salary 3rd yr % salary0.25 0.25 0.25
initial budget 2nd yr 3rd yrsalary 15,441 15,904 16,381fringe+medical 4,980 5,130 5,284Total 20,421 21,034 21,665
Personnel total 214,889 223,282 229,269 0 0
Example NIH Internal Budget
Equipment 13,659
BP/Heart Rate Monitors 10,860
Lenses 37,180 37,180
Publication Costs 1,500 3,000
Patient Stipend 10,000 10,000
Project Management 7,750 5,250
Recorders 2,300
Other direct costs 68,090 53,930 3,000
Travel 4000 3000
Total Direct costs 296,638 281,212 235,269
TOTAL Direct 813,119.34
F&A base 282,979 281,212 235,269 0 0
Total F&Abase 799,460
% for F&A
0.56
F&A 157,053 156,073 130,574 0 0
Total F&A 443,700.49
Total costs 453,691 437,285 365,844 - -
Total F&A 443,700.49
Total costs 1,256,819.83
Note: this excel spread sheet was made without the ROUNDUP function,
therefore final values differ slightly from those in the NIH application
Hidden Costs (The NIH won’t pay for What?!)
• Salary in excess of salary cap» Example: if a salary is $200,000 and the PI has 10% effort:
10% of base salary = $20,000Minus 10% of salary cap = $18,700• Department cost share = $1,300
• IDS Pharmacy Costs» Per the Chief Grants Management Officer, this is an
“institutional” expense, and not allowable
Important Resources to Remember
• OSR Toolkit: Developing a Budget» http://research.unc.edu/offices/sponsored-
research/resources/research-toolkits/developing-submitting-proposals/data_res_osr_proposalbudget/
• OSR Information Sheet (updated fringe benefits, etc.):» http://research.unc.edu/offices/sponsored-
research/resources/data_res_osr_infosheet/• NIH Grants Policy Statement Section 7.2: Cost Principles:
» http://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.2_the_cost_principles.htm
• NIH Grants Policy Statement Section 7.9: Allowability of Costs/Activities:» http://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.9_
allowability_of_costs_activities.htm
INVESTIGATIONAL DRUG SERVICE (IDS)Sue Pope, PharmacistManager, UNC IDS
IDS Operational Overview • IDS staff
– 3 Pharmacist and 4 Technician FTEs• Studies managed
– Over 330 total studies managed annually• IDS hours of operation
– 0730 to 1600 Monday through Friday – IDS closed on major hospital and university holidays
• Locations– 3rd floor Memorial Hospital - Prepares medications for
protocols that contain IV products– Ground floor Neurosciences Hospital- Prepares
medications for protocols that only contain oral, non-chemotherapy medications
– 3rd floor North Carolina Cancer Hospital
IDS StaffLEADERSHIP• John Valgus, RPh
Manager, IDSEmail: [email protected]: 347-1047Office: 984-974-8238
• Lindsey Amerine, PharmD, MSAssistant Director, Oncology, IDSPager: 919-216-6597
PHARMACISTS• Linda Manor, RPh -
[email protected]• William Zhao, PharmD, PhD
[email protected]• Elaine Vu, PharmD
[email protected]• Lynda Haberer, Rph, PhD (per diem)• [email protected]
IN AN EMERGENCY:• Outside of normal business
hours – IDS maintains an on-call pager
• In an emergency, an IDS clinical pharmacist can be reached by dialing 919-216-9727. They will provide assistance with:
• Individual drug or research questions
• The breaking of a treatment blind
• Provide support for inpatient or IV room staff who may be unfamiliar with a particular research protocol
Investigational Drug Service
Memorial Hospital, 3rd Floor• 984-974-6359 (fax for orders)• Prepares medications for protocols that
contain IV products
Neurosciences Hospital, Ground Floor• 984-974-3471 (fax for orders)• Prepares medications for protocols that only
contain oral, non-chemotherapy medications
Do I need to use IDS for my research protocol?• For research protocols within the Hospital system, the
clinical and distributional services of IDS are required• IDS Pharmacy required to be involved with all
investigational studies that use an agent/drug – Joint Commission Medication Management standards
• An agent/drug (including supplements) will be considered investigational, if following two criteria met:1. Administration of agent is part of protocol which requires IRB
approval2. A subject is required to sign an Informed Consent Form before
receiving the agent• Study locations other than main Hospital (e.g. Southern
Village, Carrboro Dialysis, UNC School of Dentistry, EPA, etc)
How and when do I initiate a request for IDS services?• Request for IDS services should be initiated simultaneously with Contract negotiation (OCT) and request for IRB approval
• IDS needs notification 6 to 8 weeks prior to 1st
study subject enrollment• Use Clinical Research Management System (CRMS) to submit protocol materials to IDS
• Or, email a completed IDS Request for Services (RFS) form, an Intensity Worksheet, and copy of protocol to the IDS manager.
What do the services of the IDS cost?• Complexity of protocol determines extent of IDS services used and cost.
• Protocol Intensity Worksheet uses a fee for service pricing structure to determine budget for study. –Score the protocol with a point based system to
determine the level of service–4 levels of service - the level determines the start up
and monthly fee. –One time start up fee, non-refundable, charged as soon
as notebook is ready for dispensing.• Once drug is received and on shelf in IDS, begin billing monthly fee.
• IDS ceases to bill when the drug has been removed from the pharmacy and a final pharmacy close out visit has been conducted.
• Need protocol intensity worksheet before IDS can process memo for IRB.
New IDS Billing Procedures • Billing will now use the Vestigo Software system• Billing will be monthly• Bills will come from Support@McCreadiegroup • Bills will be sent via email to the PI or any contact that is
given to the IDS manager• Payments will be remitted to General Accounting• If your study is open any portion of the month you will be
billed for that month.• Notify study closings by the 25th of the month to avoid
further billing.
What types of products can be compounded by IDS?
• IDS can participate in treatment and placebo blinding for solid oral dosage forms
• More complex compounding (liquid formulations, suppositories, troches, patches, etc) are outsourced to a local compounding pharmacy–Compounding fees of the local pharmacy apply in addition to standard IDS fees
How are research protocols handled outside of normal business hours?
• Approximately 95% of research protocols are handled during normal business hours (M-F, 0730 to 1600)
• However, if a research protocol will require after hour dispensation, an assigned pharmacist can coordinate this with Hospital inpatient Pharmacy or IV room
• IDS pharmacist will coordinate delivery and storage of materials to the IV room/Inpatient Pharmacy as well as provide necessary in-services to the staff
Scheduling a Monitoring Visit
• In an effort to accommodate all sponsors, monitoring visits and site initiation visits must be coordinated in advance. Contact your assigned pharmacist or call IDS• Call 984-974-0469 or 984-974-3777 to schedule a
monitoring visit• 2 monitoring visits allowed per day per IDS work
area• Scheduled typically a month or more in advance• “Remote” monitoring visits are typically not
supported by IDS
How are Investigational Medications Dispensed? IDS can begin preparing an investigational medication foryour patient ONLY when:
1. Completed protocol orders are faxed to 3W IDS or NS IDS Pharmacy
2. Orders must be signed by provider listed on 1572 and IRB application (original signature, not a copy)
3. Coordinator must give IDS verbal confirmation that patient is available for treatment (if pertinent to protocol)
4. Coordinators must present an original signed prescription order when picking up an investigational medication in the IDS pharmacy.
Paper vs. Epic Orders• All CTM that is dispensed on an outpatient basis will be
paper orders i.e. CTM is going home with subject• CTM that is administered in the clinic or in CTRC by clinic
nurses will be on EPIC so it can be recorded on the MAR• All infusions are entered on EPIC and should have a build
in the pump library under Study (name of drug)• Epic builds with start with the word STUDY and then the
name of the protocol for ease of finding the build. • Epic orders should not be entered in advance of subject’s
treatment day unless CTM can be prepared ahead.
To whom and where can Clinical Trial Materials (CTM) be sent?
• After contacting IDS (984-974-0469) to make them aware of the incoming shipment as well as total volume of expected shipment, CTMs can be directed to the following address:
Investigational Drug Services3rd Floor, Room N3122
101 Manning DriveChapel Hill, NC 27514Phone: 984-974-0469Fax: 984-974-6359
UNC INVESTIGATIONAL DEVICE POLICYMarie Rape, RN, BSN, CCRCAssociate Director, TraCS Regulatory Service
OverviewThe University of North Carolina Health Care System must ensure compliance with regard to utilization of investigational devices.
• There is a policy that governs:http://intranet.unchealthcare.org/policies/unc-hcs-policies-pdf-new-format/ADMIN0207.pdf
• Administrative Procedures• Device Receipt• Device Storage• Device Use/Dispensing• Device Return
Administrative ProceduresPrior to use of an investigational device, the following has to occur:
• IRB approval• Final sponsor budget- will sponsor provide device free of cost or
must UNC Hospitals purchase? (contact Hospital Purchasing)
• Contract must be fully executed (UNC Office of Clinical Trials)
• Must enter trial in CRMS and complete Billing Coverage Analysis (to obtain codes and charges from Integrated Billing Office)• See Research Central for IDE Billing Process guidance document• https://irbis.research.unc.edu/crms/researchcentral/
• Notify UNC HCS Reimbursement of pending trial. They will coordinate with Medicare Fiscal Intermediary.
Receipt, Storage, Use/Dispensing, Return
• Device Receipt-• What Does Protocol say?• Request Sponsor to notify of shipment• Comply with Sponsor documentation requirements
• Device Storage-• Secure, segregated, clearly identified as investigational
• Device Use/Dispensing-• Record use/dispensing information
• Device Return-• Read clinical trial agreement to see if contract terms govern• Record information• Work with UNC Hospital Purchasing to return unused devices.