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Protocol Administrative Letter March 25, 2020, Protocol 201301106 A Phase II Trial of Neoadjuvant PD 0332991, a CyclinDependent Kinase (CDK) 4/6 inhibitor, in Combination with in Women with Clinical
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Go to the website www.spirit-statement.org and navigate to the 'Protocol Amendments' section.
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Anyone involved in clinical research and in need of making amendments to the protocol, including researchers, study coordinators, and clinical trial sponsors.
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www.spirit-statement.org/protocol-amendments/protocol amendments/guidance for clinical provides guidance on how to make amendments to clinical study protocols.
Researchers conducting clinical studies are required to file www.spirit-statement.org/protocol-amendments/protocol amendments/guidance for clinical.
To fill out www.spirit-statement.org/protocol-amendments/protocol amendments/guidance for clinical, researchers must follow the instructions provided on the website.
The purpose of www.spirit-statement.org/protocol-amendments/protocol amendments/guidance for clinical is to ensure that any amendments made to clinical study protocols are properly documented and implemented.
The information that must be reported on www.spirit-statement.org/protocol-amendments/protocol amendments/guidance for clinical includes details of the proposed amendments, rationale for the amendments, and any potential impacts on the study.
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