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Protocol Number: TROV052Official Title: A Phase 1b/2 Study of Onvansertib (PCM075) in Combination with Either Low does or Decidable in Subjects with Acute Myeloid Leukemia (AML) NCT Number: NCT03303339Document

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How to fill out an open-label multicenter phase

01

Obtain approval from the appropriate regulatory bodies to conduct the trial at multiple centers.

02

Recruit participating centers with experience in conducting clinical trials.

03

Train study coordinators at each center on the protocol and data collection procedures.

04

Assign a primary investigator to oversee the study at each center.

05

Develop a standardized protocol for all participating centers to follow.

06

Monitor and track patient enrollment and data collection at each center.

07

Analyze the collected data and report findings from the multicenter study.

Who needs an open-label multicenter phase?

01

Pharmaceutical companies looking to test the efficacy and safety of a new drug on a larger scale.

02

Researchers wanting to study the impact of a treatment across different populations or geographic regions.

03

Patients with rare diseases who may benefit from access to experimental treatments available at multiple centers.

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What is an open-label multicenter phase?

An open-label multicenter phase is a type of clinical trial where both the researchers and participants are aware of the treatment being administered.

Who is required to file an open-label multicenter phase?

Researchers or organizations conducting the clinical trial are required to file an open-label multicenter phase.

How to fill out an open-label multicenter phase?

To fill out an open-label multicenter phase, researchers need to accurately document the treatment being administered, outcomes observed, and follow the regulatory guidelines.

What is the purpose of an open-label multicenter phase?

The purpose of an open-label multicenter phase is to gather data on the safety and efficacy of a treatment in a diverse patient population across multiple centers.

What information must be reported on an open-label multicenter phase?

Information such as the study protocol, treatment administration details, adverse events, and outcomes must be reported on an open-label multicenter phase.

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