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CONFIDENTIALClinical Study Protocol Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB3111 with Obinutuzumab in Subjects with Cell Lymphoid MalignanciesProtocol

How to fill out a phase 1b study

How to fill out a phase 1b study

1. Review protocol and study documentation.
2. Ensure all required forms are completed accurately.
3. Collect and organize patient data.
4. Follow study guidelines for sample collection and processing.
5. Record any adverse events or side effects experienced by patients.
6. Submit study results to regulatory authorities.

Who needs a phase 1b study?

1. Companies developing new drugs or medical treatments.
2. Researchers conducting clinical trials.
3. Regulatory authorities overseeing drug approval processes.

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What is a phase 1b study?

A phase 1b study is a clinical trial that follows phase 1a trials, focusing on evaluating the safety and efficacy of a new drug or treatment in a larger group of participants, often those who have a specific disease or condition.

Who is required to file a phase 1b study?

Sponsors of clinical trials, typically pharmaceutical companies or research institutions, are required to file a phase 1b study with regulatory agencies to assess the development of new treatments.

How to fill out a phase 1b study?

To fill out a phase 1b study, sponsors need to complete a regulatory submission form that includes study design, objectives, participant eligibility, safety monitoring plans, and informed consent protocols.

What is the purpose of a phase 1b study?

The purpose of a phase 1b study is to further evaluate the safety, dosage, and preliminary efficacy of a drug or treatment after initial testing in a smaller phase 1a trial, usually involving a specific cohort.

What information must be reported on a phase 1b study?

Information to be reported includes study methodology, participant demographics, adverse events, efficacy results, pharmacokinetics, and any interim findings relevant to the study.