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A Pilot Trial for a Inferiority Trial of ClinicianCollected Versus PatientCollected Cervical Papanicolaou Smears. NCT01214330 August 23, 2011OI 40A022Attachment 21 Jan 2009A Pilot Trial for a Inferiority

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How to fill out sample size reassessment in

01

Determine the current sample size being used for the study.

02

Review the study design and research objectives to understand the need for sample size reassessment.

03

Calculate the statistical power required for the study.

04

Evaluate potential sources of bias and variability in the data.

05

Use statistical software or calculators to determine the optimal sample size needed based on the updated information.

06

Document the rationale for the sample size reassessment and any adjustments made.

07

Communicate the findings and recommendations to relevant stakeholders.

Who needs sample size reassessment in?

01

Researchers conducting clinical trials

02

Academic researchers designing studies

03

Policy makers making data-driven decisions

04

Companies conducting market research

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What is sample size reassessment in?

Sample size reassessment refers to the process of evaluating and potentially adjusting the sample size for a study or trial based on interim data or changing study conditions.

Who is required to file sample size reassessment in?

Researchers and sponsors of clinical trials or studies that involve statistical analyses are required to file sample size reassessment when significant changes in circumstances arise.

How to fill out sample size reassessment in?

To fill out a sample size reassessment, one must provide details on the original sample size, the reasons for reassessment, any interim results that may influence the sample size, and the proposed new sample size.

What is the purpose of sample size reassessment in?

The purpose of sample size reassessment is to ensure that a study has sufficient power to detect a statistically significant effect while minimizing resources and ensuring ethical considerations.

What information must be reported on sample size reassessment in?

The report on sample size reassessment must include the original sample size, the rationale for reassessing, any statistical analysis conducted, and the new proposed sample size along with justifications.

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