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Working Memory Training combined with Transcranial Magnetic Stimulation in Smokers. NCT03337113 Document date 4/4/2018IRB v. 2015.08.17IRB # 1705003/Irene# 1054787BUTLER HOSPITAL INSTITUTIONAL REVIEW

How to fill out a single-arm multicenter study

How to fill out a single-arm multicenter study

1. Identify the objectives and research questions of the study.
2. Define the inclusion and exclusion criteria for participants.
3. Obtain approval from the relevant ethics committee or institutional review board.
4. Recruit study sites and collaborators at multiple centers.
5. Develop a standardized protocol for data collection and management.
6. Train study staff on the protocol and procedures.
7. Enroll participants at the different study centers.
8. Collect and analyze the data according to the study protocol.
9. Interpret the results and draw conclusions based on the findings.
10. Prepare a manuscript for publication in a peer-reviewed journal.

Who needs a single-arm multicenter study?

1. Researchers and scientists conducting clinical trials or observational studies.
2. Pharmaceutical companies developing new drugs or medical devices.
3. Healthcare providers looking to evaluate the effectiveness of a new treatment or intervention.
4. Regulatory agencies assessing the safety and efficacy of medical products.
5. Funding organizations interested in supporting research projects with potential public health impact.

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What is a single-arm multicenter study?

A single-arm multicenter study is a type of clinical trial where all participants receive the same experimental treatment. The study is conducted at multiple sites or centers.

Who is required to file a single-arm multicenter study?

The principal investigator or sponsor of the study is required to file a single-arm multicenter study.

How to fill out a single-arm multicenter study?

To fill out a single-arm multicenter study, the investigator needs to provide detailed information about the study design, participant eligibility criteria, treatment protocol, data collection methods, and monitoring procedures.

What is the purpose of a single-arm multicenter study?

The purpose of a single-arm multicenter study is to evaluate the safety and efficacy of a new treatment or intervention in a larger and more diverse patient population than would be possible at a single site.

What information must be reported on a single-arm multicenter study?

Information that must be reported on a single-arm multicenter study includes study objectives, methodology, participant demographics, treatment regimen, adverse events, and study results.