Clinical Trials Contracts Request Forms - UC Davis Health 2025

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Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment. Phase II trials test if one type of cancer responds to the new treatment. Phase III trials test if a new treatment is better than a standard treatment.
Generally, the sponsor is responsible for ensuring that an up-to-date IB is made available to the investigator(s) and the investigators are responsible for providing the up-to-date IB to the responsible IRBs/IECs.
Data Management in Clinical Trials CRAs are responsible for data collection and documentation as well as are often responsible for managing trial-related supplies and other research-related support tasks.
Obtaining information about living individuals by intervening or interacting with them for research purposes; Obtaining identifiable private information about living individuals for research purposes; Obtaining the voluntary informed consent of individuals to be subjects in research; and Studying, interpreting,
Yes, investigators are responsible for obtaining and documenting the informed consent of research subjects or their legally authorized representatives, unless the IRB approves a waiver of informed consent, or a waiver of documentation of informed consent, respectively (45 CFR 46.116, 45 CFR 46.117).
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It is usually prepared by the sponsor of the study, and it is intended to provide essential information to the investigators involved in the study.
In general, you do not pay extra out-of-pocket costs for treatments studied in a trial. Most often, the clinical trials sponsor pays for all research-related costs and any special testing.
We use the CTA to define study-specific details, such as the number of subjects to be enrolled, ownership of the study data and/or samples, any intellectual property rights, publication rights and other matters pertaining to the study.

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