CREATING BUDGETS - THE BASICS

AGENDA

• REVIEW OF STUDY PROTOCOL AND DESIGN

• REVIEW OF STUDY SCHEMA

• DEVELOPMENT OF STUDY BUDGET

• BUDGET NEGOTIATION

• BUDGET MANAGEMENT

• REIMBURSEMENT

Review of Study Protocol and Design Protocol Review

Department Review

IRB Review

Develop and Negotiate

Budget Contract

Review and Negotiation

Finalize: Budget

Contract IRB

STUDY SCHEMA • STUDY-REQUIRED

LABORATORY TESTS

• STUDY-REQUIRED PROCEDURES

• STUDY DRUG ADMINISTRATION AND SCHEDULE; RESEARCH PHARMACY

• STUDY-SPECIFIC ELEMENTS AFFECTING MANPOWER

• LOCATION WHERE RESEARCH WILL OCCUR

• REVIEW PROTOCOL FOR ITEMS NOT IN SCHEMA

BUDGET DEVELOPMENT and

NEGOTIATION

BUDGET : n 1. Total amount of money allocated for a certain purpose. 2. The estimated cost of living, operating, etc. -vt 1. To put on a budget.

WHAT IS A BUDGET?

ANALYZE THE PROTOCOL

• LABORATORY TESTS • PROCEDURES • STUDY DRUG • PHARMACY NEEDS • RESEARCH NURSING • DATA MANAGEMENT • ADMINISTRATIVE EFFORT • PRINCIPAL INVESTIGATOR • SUPPLIES • DATA STORAGE

STUDY BUDGET

PROCEDURES LABS

STUDY DRUG PHARMACY

MANPOWER

OTHER COSTS

IDENTIFY STUDY COSTS

Key Personnel

Lab Costs Procedure Costs

Indirect Costs

Pharmacy Costs

Miscellaneous Costs

IDENTIFY KEY PERSONNEL COSTS

• PRINCIPAL INVESTIGATOR (P.I.) • STUDY COORDINATOR • DATA MANAGER • PHARMACIST • ADMINISTRATIVE

– CLERICAL – FINANCIAL – NURSE MANAGER – REGULATORY

PRINCIPAL INVESTIGATOR • EVALUATE EFFORT • INVOLVEMENT

–PER PATIENT –PER VISIT –PER TREATMENT CYCLE

• CONSIDER –EXTENDED TIME FOR RESEARCH –TELECONFERENCES –CRFs –MONITOR VISITS

ESTIMATING HOURS FOR STUDY COORDINATION

STUDY INITIATION ----------------> ARCHIVING

• STUDY INITIATION PROCESSES: ON-SITE VISIT, INSERVICE OF STAFF, AREAs

• SCREENING/RECRUITMENT • PATIENT CARE: ENROLLMENT, PATIENT EDUCATION, TREATMENT, FOLLOW UP,

TOXICITY REPORTING, QOL, DIARIES

• ADMINISTRATIVE: IRB, FDA, SPECIAL AREAS, MONITORS

• TELEPHONE, FAX, COMPUTER TIME REQUIRED • HOSPITAL ROUNDS, STUDY VISITS • CRF COMPLETION, QUERY RESOLUTION • BILLING COMPLIANCE

ESTIMATING HOURS FOR DATA MANAGEMENT

STUDY INITIATION ----------------> ARCHIVING

• STUDY INITIATION PROCESSES • PATIENT CARE DOCUMENTATION: ENROLLMENT, PATIENT EDUCATION, TREATMENT, FOLLOW UP,

TOXICITY REPORTING, QOL, DIARIES • ADMINISTRATIVE: IRB, FDA, SPECIAL AREAS,

MONITORS • TELEPHONE, FAX, COPIER, COMPUTER TIME REQUIRED • RADIOGRAPHIC REVIEWS

RADIOLOGY, CARDIOLOGY, ETC. • CRF COMPLETION, QUERY RESOLUTION • STUDY ARCHIVAL

PHARMACY COSTS BRING in RESEARCH PHARMACIST: • REVIEW and DISCUSSION of PROTOCOL • DRUG ACCOUNTABILITY and STORAGE • DRUG PREPARATION: MIXING, LABELING • DRUG DISPENSING (INCLUDING PATIENT ED.) DELIVERY to HOSPITAL or CLINIC • KNOWLEDGE of DRUG TOXICITIES/INTERACTIONS • DRUG ORDERING, TRACKING EXPIRATION DATES • DRUG RETURNS or DESTRUCTION at END of STUDY • ADMINISTRATIVE: IRB, FDA, MONITORS, STAFF

LABORATORY AND PROCEDURE COSTS

• IDENTIFY LOCAL POLICIES and GUIDELINES --- LOCAL REVIEW

--- LABS, PROCEDURES billed by Providers

• COSTS are TIME-SENSITIVE --- BUDGET for INCREASES

• ANCILLARY AREAS

--- CONTACT DIRECTLY --- SPECIAL FEES --- RESEARCH ONLY SERVICES

PATIENT STIPENDS

• DETERMINED BY PROTOCOL REQUIREMENTS

– INVASIVE PROCEDURES

–TIME CONSUMING PROCEDURES

–EXTRA OFFICE VISITS

–TRAVEL TIME, PARKING

–PHARMACEUTICAL COMPANY or IRB INPUT

MISCELLANEOUS COSTS

• INDIRECT COSTS • LOCAL IRB, CENTRAL IRB, SPECIAL RESEARCH AREAS • SCREENING and RECRUITMENT, ADVERTISEMENT • STORAGE (DRUG, SAMPLES, DATA) • MEDICAL RECORDS • MACHINE USE (COPIER, FAX, COMPUTERS, FREEZERS) • SOCIAL SERVICES • SUPPLIES (OFFICE, MEDICAL) • ELECTRONIC DATA CAPTURE • SHIPMENTS (OVERNIGHT COURIERS)

REMINDERS • MAKE SURE THE PROTOCOL IS FINAL • DATE THE BUDGET; LINK TO PROTOCOL VERSION and DATE • MARK BUDGET “VERSIONS” • ALLOW FOR ANNUAL INCREMENTAL INCREASES • ENSURE SCREEN FAILURES ADDRESSED • CANCELLATION FEES • STUDY MONITOR VISITS/ON-CALL PAY • INTERNAL START-UP MEETINGS • PROTOCOL AMENDMENTS; IF ↑ COSTS, CONTACT SPONSOR

to NEGOTIATE AMENDED CONTRACT BUDGET • POST STUDY (QUERIES, NOTIFYING PATIENTS, FDA, ETC.)

ASK THE SPONSOR • WILL A CENTRAL LAB BE USED?

--- WILL SAMPLING SUPPLIES, SHIPPING/HANDLING MATERIALS, PRE-PAID AIRBILL BE PROVIDED?

• WILL THERE BE ANY OTHER CENTRAL REVIEWS? --- RADIOLOGY, NUCLEAR MEDICINE, CARDIOLOGY, ETC.? • REQUEST APPLICABLE STUDY MANUALS • TIMING OF MONITORING VISITS, STUDY PAYMENTS • STUDY PAYMENTS VIA INVOICE

--- CONSIDER AN INVOICE or ADMINISTRATIVE FEE • DIRECT PAYMENT TO IRBs

BUDGET PREPARATION

• METHOD –ELECTRONIC SYSTEM –EXCEL SPREADSHEET –WORD PROCESSOR *OBSOLETE –PEN/PAPER *OBSOLETE

• TYPES –SUMMARIZED –DETAILED –EXAMPLE FOLLOWS

REVIEW THE BUDGET

• WITH P.I. AND KEY PERSONNEL (CLINICAL and FINANCIAL)

• P.I./COORD DESIGNATES ITEMS THAT ARE STANDARD CARE (BILLED TO & REIMBURSED by THIRD PARTY PAYORS)

• WHEN IN DOUBT ABOUT THIRD PARTY BILLING, CHECK WITH LOCAL AREAS - COMPLIANCE OFFICE, PATIENT BILLING OFFICES, ETC.

FINALIZE THE BUDGET • REVIEW ANY CHANGES WITH STAFF (PI, KEY PERSONNEL)

• REQUEST A NON-REFUNDABLE ADMINISTRATIVE START-UP FEE –Separate from per patient budget or IRB fees

• OBTAIN APPROPRIATE INTERNAL APPROVALS

• SUBMIT TO SPONSOR FOR APPROVAL

• NEGOTIATE, NEGOTIATE, NEGOTIATE

• DATE BUDGET AND MARK WHEN “FINAL”

NON-REFUNDABLE ADMINSTRATIVE START-UP FEE

CONSIDER THE FOLLOWING IN FEE ESTIMATION:

• CONFIDENTIALITY AGREEMENT PROCESS • SPONSOR FEASIBILITY / SITE QUALIFICATION • ATTENDANCE AT INVESTIGATOR MEETING • INTERNAL REVIEWS • INITIAL IRB SUBMISSION ACTIVITIES • REGULATORY DOCUMENT MANAGEMENT

– COMPILATION, SUBMISSION TO SPONSOR, SET-UP FILES – BUDGET DEVELOPMENT / NEGOTIATION

• INITIATION / START-UP MEETINGS

PAYMENT SCHEDULE

• NEGOTIATE ACCORDING TO THE FLOW OF THE PROTOCOL AND ESTIMATED FINANCIAL NEEDS

• % PER ENROLLED PATIENT

• % PER COMPLETED TREATMENT CYCLE

• % PER “COMPLETED” PATIENT (CHECK DEFINITION IN THE PROTOCOL and/or CONTRACT)

• AMOUNT PER CRF / VISIT ON A MONTHLY OR QUARTERLY BASIS

BUDGET MANAGEMENT

• SET UP STUDY ACCOUNT NUMBER

• IF THERE ARE MULTIPLE SOURCES OF SUPPORT FOR ONE STUDY, CONSIDER SEPARATE ACCOUNTS FOR EACH SOURCE OF SUPPORT

• STUDY EXPENSES CHARGED TO THE ACCOUNT NUMBER(S)

REIMBURSEMENT • KNOW WHAT THE CLINICAL TRIAL CONTRACT SAYS

• TRACK/DOCUMENT: PATIENT SCREENING, PATIENT VISITS,

MONITORING / CRF COLLECTION PER PATIENT

• PRO-ACTIVELY INVOICE THE SPONSOR UTILIZING – DATA FROM ELECTRONIC MANAGEMENT SYSTEM – SPREADSHEET DOCUMENTATION – SPONSOR FORM

• OBTAIN SPONSOR APPROVAL FOR ONE-TIME or UNEXPECTED COSTS AND INVOICE AS THEY OCCUR

• DOCUMENT WHEN IT IS THE FINAL INVOICE

POST-STUDY BUDGET EVALUATION

• WAS THERE A BALANCE IN LABOR VS. REIMBURSEMENT?

• WHAT HIDDEN COSTS WERE COVERED or NOT COVERED?

• WERE MONITORING VISITS TOO LABOR INTENSIVE?

• WAS THE PAYMENT SCHEDULE EQUITABLE?

• IS THERE ROOM FOR IMPROVEMENT REGARDING COST OF DOING THE TRIAL AND THE BOTTOM LINE?

• IF YOU HAD TO DO IT OVER AGAIN, COULD YOU DO IT FOR THE SAME AMOUNT (AND NOT REQUIRE SUPPLEMENTAL RESOURCES TO COVER YOUR COSTS?)

BILLING COMPLIANCE

REMINDER:

IF THE SPONSOR IS PAYING FOR A SERVICE, DON’T BILL THIRD PARTY PAYORS!