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NIDCR Protocol Template - Webtools
Provide a brief sample size calculation or description of sample size calculation. Include methods and assumptions such as loss to follow-up, as appropriate. 13.0 Regulatory Requirements. 13.1 Informed Consent . Describe how informed consent will be obtained and who will obtain it.

Appendix A – Tables
Exceptions to the Maximum Allowable Variations – 1 package may exceed the MAV for every 12 packages in the sample. **If sample size is 11 or less, the initial tare sample size and the total tare sample size is 2 samples. (Amended 2001) Table 2-2. Sampling Plans for Category B. For Use In USDA-Inspected Meat and Poultry Plants Only 1 2 3 4

U.S. Food and Drug Administration
Therefore, analytical sensitivity of the test with n-sample pools should be evaluated. FDA believes an n=5 is a reasonable starting point for validation of pooling for a high-sensitivity test in ...

[DOCX File]Clinical Interventional Study Protocol Template
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Describe sample size calculation and effect size with respect to power. Specify the t ... indicate whether (and why) there is a sample size goal for each stratum. Identify what factors (if any) will be used to stratify the randomization. ... the NIA, the OHRP, the FDA, or other government agencies as part of their duties to ensure that research ...

[DOCX File]Clinical Intervention Study Protocol Template
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Jul 17, 2015 · ups/arms including sample size (including a table, if appropriate) Study location (e.g., in-patient or out-patient, clinic, community) Approximate . duration of . enrollment period and follow. up (specify individual participant vs. entire trial) Description of intervention and administration

[DOC File]NIDCR Protocol Template
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Jan 21, 2019 · Provide a sample size justification or description of a sample size calculation. Include methods and assumptions such as expected effect size, loss to follow-up, as appropriate. 8 Data Confidentiality and storage. Describe who will collect and have access to the data/specimen repository/completed surveys/focus group results.

U.S. Food and Drug Administration
Ideally, the specimens should be sequentially collected in a blinded fashion, and therefore, the total sample size of your study will depend on the prevalence of SARS-CoV-2 in your study population.

[DOC File]Sample Size Re-estimation - Biopharmnet
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Conceptually, the treatment effect size used in sample size calculation is not simply an expectation of the magnitude of effect. While the assumed effect size should be feasible based upon what is known about a treatment, this is a value that also should reflect …

[DOCX File]Clinical Intervention Study Protocol Template
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Justify any aspects of the study that are not FDA-approved (e.g., different dosing schedule, new combination of drugs, new drug formulation). ... and document your methods for sample size calculation. Include a sensitivity analysis reflecting the impact of potential differences between the estimate and the realized value of the intraclass ...

[DOCX File]FDA Form 3514 - Duke Clinical & Translational Science ...
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Explanation of sample size that provides a sound statistical basis for the determination of sample size (N). Proposed plan for how you will analyze data (e.g., identify independent and dependent variables, provide interpretation criteria and your definition of positive, negative, or equivocal results).

Sample size calculation fda