Evaluation of a Protocol Budget

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Sample <strong>Protocol</strong> Trial 1 Women w/ prior SD NVP exposure for PMTCT N = 240 Trial 2 Women with no prior NVP exposure N = 400 Randomize 1:1 Arm 1A • NVP QD x14D then BID • TDF QD • FTC QD Arm 1B • LVP/RTV BID • TDF QD • FTC QD IPPCR 12/15/09 Slide # B
Requirements <strong>Protocol</strong> • Eligibility • Schedule • Investigator’s Brochure • Lab Manual • Contract Terms Site • Personnel • Equipment • Toxicity Management • Research vs. SOC IPPCR 12/15/09 Slide # 3
Page 1 and 2: Evaluation of a Protocol Budget Mar
Page 3: Sample Protocol Phase 3, open label
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 and 16: Protocol • Treatment & Evaluation
Page 17 and 18: • Clinical Monitoring ∗ Adheren
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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