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Operationalizing Compliance Requirements in Clinical Trials

Operationalizing Compliance Requirements in Clinical Trials. University of Colorado Denver | Anschutz Medical Campus. Presented at NCURA Wednesday April 6 , 2011. Hot Topics. Regulatory (IRB) Role Clinical Trial Agreement (legal and business issues/terms) Budget Negotiation

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Operationalizing Compliance Requirements in Clinical Trials

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  1. Operationalizing Compliance Requirements in Clinical Trials University of Colorado Denver | Anschutz Medical Campus Presented at NCURA Wednesday April 6, 2011

  2. Hot Topics • Regulatory (IRB) Role • Clinical Trial Agreement (legal and business issues/terms) • Budget Negotiation • PI/Clinician Perspective • Conduct of Protocol • Other considerations

  3. Clinical Trial Summary • Career Induced Attention Deficit Disorder-CIADD • Progressive neuropsychological disorder • Pervasive at Academic Research Institutions • Pater piling/hoarding • Inability to stay on task and complete projects • Incomplete e-mail syntax, headaches, tremors, spontaneous verbal/emotional outbursts

  4. Clinical Trial Summary • Progressing and unremitting • >80% patients are completely debilitated within 5 years • Current treatment-gabapentin and haloperidol • Modest improvement to symptoms • Slows disease progression in ~ 50% of patients

  5. IM Pharma, Inc. • IMP-1138 • Acts on the CNS • Safe, well-tolerated in preclinical and Phase I/IIa clinical studies • Drug regimen: • Double-blind, randomized, placebo-controlled 12-month trial • Open-label IMP-1138 for next 12 months • Standard care counseling • Monthly clinic visits

  6. InstitutionalReview Board • Research vs. Standard of Care • Vulnerable Populations • FDA vs. DHHS Regulations • Consent form • Readability • Consent Traps • Biobanking

  7. Clinical Trial Agreement • Publications • Intellectual Property • Subject Injury Language • 3rd Party Payor Language

  8. Clinical Trial Agreement • Indemnification • Sponsor vs. Investigator-Initiated • Law/Venue • Contract Research Organization (CRO)

  9. Budget Negotiation • Payment schedule • Final payment terms • Upfront payment/Startup fees • IRB Payment • Screen Failure Payment • Invoiceable Items

  10. Clinician Perspective • Clinician/PI conflicted role • Oversight of the patient’s care • Moving science forward • Funding • Consent Process • Navigating IRB/Sponsor requests • Time Commitment • Investigator Meetings • Trusted Coordinator/PRA • Consent form (exculpatory language)

  11. Clinical-Conduct of Protocol • Enrollment Requirements • Start, deadline, numbers • CRF Review/Monitor review • Frequency and duration • eCRF • CRC and DM Time • Billing compliance

  12. Other Considerations • Master Agreement-how much does it help? • Template informed consent Language-bridge the gap to ensure CTA and ICF match? • Statement of Fees • Long-term relationship between pharma and university: a two-way street?

  13. Thank you University of Colorado Denver

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