Multi dose 28 day calendar
[DOCX File]Protocol Signature Page
https://info.5y1.org/multi-dose-28-day-calendar_1_178d5d.html
For studies in which multi-dose vials are utilized, provide additional information regarding stability and expiration time after initial use (e.g., the seal is broken). Side Effects Complete and updated adverse event information is available in the Investigational Drug Brochure (IB) and/or product package insert.
[DOCX File]Tool Summary Sheet: Clinical Monitoring Plan Template
https://info.5y1.org/multi-dose-28-day-calendar_1_d36331.html
The CRA will be available at the end of each monitoring visit day to discuss findings and answer questions from the study staff. The Site PI and Primary Site Contact are also expected to be available for a wrap-up meeting at the conclusion of the visit, as schedules allow. ... and it is a multi-center trial, CROMS can be delegated to maintain ...
[DOC File]A double blind, randomized, controlled, dose escalation ...
https://info.5y1.org/multi-dose-28-day-calendar_1_3ebf25.html
(N=5 in each arm) Cohort Day 0 Day 14 Day 28 Day 42 Day 84 Day 98 1/5 Dose (10 (g) Average 12 312 462 18066 7371 32648 Std Dev 8 191 236 8406 6304 24046 Geo …
[DOC File]TEMPLATE INSTRUCTIONS
https://info.5y1.org/multi-dose-28-day-calendar_1_15ca15.html
Subjects will receive Agent X ___ mg/m2 on Days 1-3 of each (28 day) cycle. Agent X will be administered IV over 2 hours. Example: Subjects will receive Agent Y ___ mg/m2 by IV on Day 1 of each 21-day cycle. Prior to each treatment, pre-hydrate with at least 1000 ml normal saline and use diuretics per institutional guidelines. Example:
[DOCX File]Protocol Signature Page
https://info.5y1.org/multi-dose-28-day-calendar_1_5a627d.html
Describe the regimen (drug, dose, route, and schedule) and state any special precautions or warnings relevant for investigational study drug administration (e.g., incompatibility of the drug with commonly used intravenous solutions, necessity of administering drug with food, how to round a dose of oral drug to available tablet/capsule strengths, premedications etc.), and describe in detail any ...
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