KUMC Research Institute How to Create a Clinical

KUMC Research Institute How to Create a Clinical Trial Budget Clinical Research Administration http: //www 2. kumc. edu/researchinstitute/ October 23, 2008 Presented by Kelly Daniels, CCRP

How to create a clinical trial budget § Difficulty and/or complexity of the study § Study preparation requirements § Patient numbers § Length of study § Inclusion/exclusion criteria for subject recruitment § Staffing

How to create a clinical trial budget Investigator Initiated Protocol: § Data management expenses § Study-related personnel costs § Equipment/supply expenses § Diagnostic fees and services § Publication costs (preparation of manuscript, travel, etc. )

How to create a clinical trial budget Start up Costs: § Protocol review by Investigator/study coordinator § Determine potential number of eligible subjects § Site selection visit § Site initiation visit § Off-site meetings (Investigator’s meeting)

How to create a clinical trial budget Start up Costs: § Detailed budget development § Regulatory Document preparation § IRB submission, copies and amendments § Advertising and patient recruitment § Pharmacy Protocol review/set-up costs

How to create a clinical trial budget Per subject costs: § Initial enrollment costs § Subject screening (medical history, physical exam, informed consent, lab work, x-rays, etc) § Screen failures (how many will study allow? )

How to create a clinical trial budget § Physical exams and medical assessments § Office visits § Lab work, radiology, cardiology and other medical procedures (professional fees) § Pharmacy dispensing and drug administration § Room charges and hospital bed § Determine standard of care items (as needed)

How to create a clinical trial budget § Medical supplies § Film duplication § Study drug storage facilities (locked cabinet/refrigerator) § Telephone contact § Patient instruction

How to create a clinical trial budget Administrative costs: § Data collection/management/analysis § Site visit preparation/Study monitoring/Study queries § Office supplies § Shipping/dry ice § Off site storage § Telephone charges

How to create a clinical trial budget Other costs: § Investigator fee § Study Coordinator fee § Subject stipend § General Clinical Research Center services

How to create a clinical trial budget Budget Preparation: § Line item detailed per visit budget. . BUDGETS3 BUDGET HELP FOLDERCPT bud-format by visit template-whours (ver. 8. 1). xls § Budget by frequency. . BUDGETS3 BUDGET HELP FOLDERCPTcode-bud-format freq template. xls § PI initiated budget. . BUDGETS3 BUDGET HELP FOLDERCPTcode-bud-format PI Initiated. xls

How to create a clinical trial budget Budget Negotiation: § Do not automatically accept a sponsor budget. § Do not finalize a budget until you are confident all study costs have been identified. § Do not agree to milestone payments. § Do not be afraid to ask for more money!

How CRA can help negotiate the budget Budget Negotiation: § Review consent form/schedule of events/protocol § Compare to sponsor’s budget template § Review the contract language related to the budget and payment.

How CRA can help negotiate the budget Budget Negotiation: § Negotiate fixed costs (i. e. IRB fees, pharmacy fees, administrative fees, etc. ) separately from per patients costs. § Request initial “up-front” payment to cover initial costs (protocol review, budget creation, pre-study visits, etc). § Add monies within the budget to cover time/effort of PI and study coordinator to cover work during preparation/study conduct/closure of the study.

Budget Contacts § Kelly Daniels Research and Program Officer ext 1484 § Program Administrators: § Jason Winbolt ext 5709 § Heidi Warren (off site) hwarren@kumc. edu