CREATING BUDGETS - THE BASICS

Transcription

1 CREATING BUDGETS - THE BASICS

2 AGENDA REVIEW OF STUDY PROTOCOL AND DESIGN REVIEW OF STUDY SCHEMA DEVELOPMENT OF STUDY BUDGET BUDGET NEGOTIATION BUDGET MANAGEMENT REIMBURSEMENT

3 Review of Study Protocol and Design Protocol Review Department Review IRB Review Develop and Negotiate Budget Contract Review and Negotiation Finalize: Budget Contract IRB

4 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

5 BUDGET DEVELOPMENT and NEGOTIATION

6 WHAT IS A BUDGET? 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.

7 ANALYZE THE PROTOCOL LABORATORY TESTS PROCEDURES STUDY DRUG PHARMACY NEEDS RESEARCH NURSING DATA MANAGEMENT ADMINISTRATIVE EFFORT PRINCIPAL INVESTIGATOR SUPPLIES DATA STORAGE PROCEDURES MANPOWER LABS STUDY BUDGET STUDY DRUG PHARMACY OTHER COSTS

8 IDENTIFY STUDY COSTS Key Personnel Lab Costs Procedure Costs Pharmacy Costs Indirect Costs Miscellaneous Costs

9 IDENTIFY KEY PERSONNEL COSTS PRINCIPAL INVESTIGATOR (P.I.) STUDY COORDINATOR DATA MANAGER PHARMACIST ADMINISTRATIVE CLERICAL FINANCIAL NURSE MANAGER REGULATORY

10 PRINCIPAL INVESTIGATOR EVALUATE EFFORT INVOLVEMENT PER PATIENT PER VISIT PER TREATMENT CYCLE CONSIDER EXTENDED TIME FOR RESEARCH TELECONFERENCES CRFs MONITOR VISITS

11 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

12 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

13 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

14 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

15 PATIENT STIPENDS DETERMINED BY PROTOCOL REQUIREMENTS INVASIVE PROCEDURES TIME CONSUMING PROCEDURES EXTRA OFFICE VISITS TRAVEL TIME, PARKING PHARMACEUTICAL COMPANY or IRB INPUT

16 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)

17 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.)

18 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

19 BUDGET PREPARATION METHOD ELECTRONIC SYSTEM EXCEL SPREADSHEET WORD PROCESSOR *OBSOLETE PEN/PAPER *OBSOLETE TYPES SUMMARIZED DETAILED EXAMPLE FOLLOWS

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22 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.

23 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

24 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

25 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

26 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)

27 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

28 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?)

29 BILLING COMPLIANCE REMINDER: IF THE SPONSOR IS PAYING FOR A SERVICE, DON T BILL THIRD PARTY PAYORS!