Web1.Final redacted protocol. CLINICAL PROTOCOL (FINAL) A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous ... Most protocols used a two-stage manufacturing process like that used in LN-144 production, and most trials also used a nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen prior to infusion of … WebNCT02029443 Redacted Clinical Protocol for Journal Use Page 2 . A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects with Chronic Lymphocytic Leukemia .
Redactions in protocols for drug trials: what industry sponsors ...
WebNCT01236391 Redacted Clinical Protocol for Journal Use 7 4.1. PCI-32765 DOSAGE PCI-32765 560 mg (4 × 140-mg capsules) is intended to be administered orally once daily with 8 WebNov 9, 2024 · Guidance on Protocol and SAP Redaction Practices: Information to Redact Information listed to the right is generally considered to be exempt from disclosure under the Freedom of Information Act (FOIA). This information should be redacted from the protocol document and, if separate, the statistical analysis plan. The list is saia offices
Inquiry Protocol on Redaction of Documents - IICSA
WebJan 21, 2024 · Redacted: Redaction is the process of blanking out confidential or sensitive information from a document before disclosure or publication. As electronic filing of court … WebREDACTED. Protocol: Clindamycin Obesity – NICHD-2012-CLN01 Version 1.0 IND 115,396 21OCT2012 _____ Protocol Synopsis _____ xi Table 1. Study Event Table . Study Event/Day Screening/ Study Day 0 Study Day 1 (any dose after the 1st dose of IV clindamycin; oral PK with 4th dose or later) Study Day 2–14 End of Therapy ... Web1) Redacted final protocol 2) Redacted final statistical analysis plan and statistical amendment memo Merck’s policy on posting of redacted study protocols on journal websites is described saia pick up phone number