Regulatory Science Symposium: Clinical Trial Startup Session 2: Pre-Award Activities: Contract and Budget/Managing Logistics: Study Drug, Specimen, Space (2016)

1. Presentation Title: Pre-Award Activities Contract: Budgeting for Clinical Trials
   1. Presented by Melissa L. Archer
2. Learning Goals
   1. Compliance with Medicare Secondary Payer Act
   2. Federal Anti-Kickback Laws – Budget Development
   3. Medicare Coverage Analysis
   4. Essential Terms in Clinical Trial Agreements
3. Driving Legal Concerns
   1. At USC, trials must be compliant of Medicare Secondary Payor Act (“MSP”)
      1. Expenses such as what will not be covered by private insurance and Medicare must be covered by the sponsor
   2. Federal Anti-Kickback Laws/Stark Laws
      • Fair market value
      • No discounts! The data needs to look clean.
      • No endorsements for free supply of medications
      • Safe Harbors: Everything must be outlined and written in a contract
      • Sunshine Act--- it is the responsibility of the sponsors to gather, organize, and interpret this information; objective- transparency
4. Budgeting and Contracting
   1. Budgeting Tools: Standardized Fees
      1. Fixed Start-Up Fees
      2. Fixed IRB Fees
      3. Research (CPT) Fees
      4. Research (Non-CPT) Fees
   2. Elements of a Sponsored Research Agreement
      1. Confidential Information
      2. Patent Privacy and Use of Protected Health Information
      3. Study Data
      4. Publication
      5. Protection of Inventions
      6. Identification
      7. Subject Injury Reimbursement
      8. Budget and Payment Schedule
5. Final Take-Aways
1. Research must be fully costed
2. Agreement should cover all essential elements
3. Early PI participation is important for a quick start of study
4. Understand confidentiality obligations

1. Presentation Title: Managing Study Set-Up Logistics: Study Drug, Specimen, Space
   1. Presented by Diana Palma BS, CCRP and Regina Olivas, RN, BSN, MSW
2. Logistical Considerations
   1. Storage of Research Charts
   2. Feasibility of the Study
   3. Required Training specific to the protocol
   4. Who is the sponsor?
   5. Data Entry Systems--- which system can used for which function? (ex. A particular system may store data only while another stores patient info etc.)
   6. Organizing Research Charts
   7. Is there a study drug involved?
   8.  IRB Approval
3. Feasibility
   1. Determined by PI and research team
   2. Bring up protocol, location, staff, or technical concerns early on
   3. Anticipated study enrollment expectations reviewed by all study staff
   4. Reaching out to Ancillary Services: Radiology, pharmacy, lab
      1. To ensure that protocol procedures fall within institutional scope of practice
4. Staff In-services/Education         
   1. Tailor presentations to audiences ie. Clerical staff vs. clinical nurses and physicians
   2. Performed by PI, CRC
   3. Additional services should be performed with study protocol amendments and inform all staff
5. Study Drug Management
   1. Involve the Investigational Drug (ID) Pharmacy
      1. ID Pharmacy can help with regulatory compliance integrity of blinding, preventing of errors involving drug study, dispensing the drug in timely fashion etc.
6. Specimen Storage & Handling
   1. Following topics are presented by Regina Olivas, RN, BSN, MSW
   2. Collaborate with lab and pathology
   3. Where will your specimens be stored and how to be handled?
   4. Need for refrigerators and freezers
   5. Assess equipment ie. Centrifuges and training on how to use equipment
   6. No Space may result in Off-site locations
   7. Make sure that shipping specimens are shipped in a timely manner and consider weather conditions of journey and final destination
7. Space Considerations
   1. Research files should be in lockable file cabinets
   2. Access to study staff workstation, research supply, and study drug
8. Monitor Site Visits
   1. May be a few individuals or a whole team
   2. Need a private work space for routine visits
9. Record Storage: Ongoing Studies
   1. Central location with the documentation
   2. All research charts should be accessible in case of audit
   3. Creating Standard Operating Procedure (SOP)
10. Record Storage: Closed Studies
    1. Check with institutional policies before moving or discarding research records
    2. ex. Cancer studies are ongoing -> research concerning cancer should be maintained
11. Conclusion

Accompanying text created by Annie Ly | Undergraduate Research Associate and Provost's First Generation Research Fellow | lyannie@usc.edu