Evaluation of a Protocol Budget

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Data <strong>Protocol</strong> • CRFs ∗ Development • Per Visit ∗ # Forms ∗ # Pages • Quality • Submission Site • Staff ∗ Completion ∗ QC & QA ∗ Entry ∗ PI sign-<strong>of</strong>f? • Equipment ∗ PC ∗ Fax IPPCR 12/15/09 Slide # 21
• Clinical Monitoring ∗ Adherence to protocol ∗ Adherence to regulatory & GCP • Safety ∗ SAE reporting • Data ∗ Source documentation ∗ Endpoints • Time commitment IPPCR 12/15/09 Slide # 23
Page 1 and 2: Evaluation of a Protocol Budget Mar
Page 3 and 4: Sample Protocol Phase 3, open label
Page 5 and 6: Requirements Protocol • Eligibili
Page 7 and 8: Subjects Protocol • Enrollment
Page 9 and 10: Protocol Screening • Clinical Eva
Page 11 and 12: Location • Single / Multi-site
Page 13 and 14: Protocol • Tests: # and type •
Page 15: Protocol • Treatment & Evaluation
Page 19 and 20: Personnel • Experience • Commit
Page 21 and 22: Equipment and Supplies • Clinical
Page 23 and 24: • Other Sites • Monitoring •
Page 25 and 26: IPPCR 12/15/09 Slide # 36
Page 27 and 28: Establishing a Budget continued…
Page 29 and 30: Establishing a Budget continued…
Page 31 and 32: Protocol Schedule HIV doc HX Con Me
Page 33 and 34: HIV RNA-rt HIV RNA Sc 0 Protocol Sc
Page 35 and 36: Year 1 - Routine Labs IPPCR 12/15/0
Page 37 and 38: Cost Coversheet IPPCR 12/15/09 Slid
Page 39: Contact Margaret Matula e-mail: mma

Evaluation of a Protocol Budget

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