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IRB Approved Document Release Date: 10/18/20177639Clinical Study Protocol:PD Abiraterone acetate Clinical Study Protocol Study Title:OPEN LABEL PHARMACODYNAMIC STUDY OF ABIRATERONE ACETATE IN THE
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Start by opening the COU-AA-301 protocol protocol form
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Read all the instructions and guidelines provided on the form
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Begin by filling out the personal information section, including your name, contact details, and any other required information
04
Move on to the study details section, where you will need to provide information about the research study, including the study title, ID, and objective
05
Fill out the eligibility criteria section, which may include specific requirements for participants
06
Proceed with the study design section, where you will need to outline the research methodology and any additional information required
07
Complete the intervention section, if applicable, by providing details about the treatment or intervention being studied
08
Fill out the outcome measures section, including the primary and secondary outcome measures that will be assessed
09
Provide information about the statistical analysis plan, including the sample size calculation, data analysis methods, and any statistical tests to be used
10
Finish by reviewing all the filled information for accuracy and completeness before submitting the protocol form

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Researchers and scientists conducting clinical trials or research studies are typically the ones who need to fill out the COU-AA-301 protocol form. This form helps in documenting and organizing the necessary information about the study, including the study design, objectives, eligibility criteria, intervention details, and outcome measures. It serves as a blueprint for the research study and ensures that all necessary information is properly documented and communicated to other stakeholders, such as ethics committees, regulatory bodies, and sponsors.
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