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CLINICALTRIALS.GOV NU RECORD REVIEW
PROTOCOL RECORD OWNERREVIEWERNCT#
DATE RELEASEDCOMMENTS Date Registration
q Update status
q Results
(add Results checklist)REPLY DATEGENERAL REVIEW Items pact/ACT
q
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How to fill out protocol registration and results
How to fill out protocol registration and results
01
Begin by providing all necessary information about the study, including the title, research team members, and contact information.
02
Clearly outline the study objectives, methodology, and anticipated outcomes.
03
Include detailed information about the study design, including sample size, inclusion/exclusion criteria, and data collection methods.
04
Specify any ethical considerations, such as informed consent procedures and data protection measures.
05
Register the protocol with the appropriate regulatory bodies and ensure that all required information is provided.
06
Once the study is completed, fill out the results section with detailed findings, including any statistical analyses and conclusions.
Who needs protocol registration and results?
01
Researchers conducting clinical trials or other types of studies that involve human participants.
02
Institutions and organizations involved in research funding or oversight.
03
Regulatory bodies responsible for reviewing and approving research protocols.
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What is protocol registration and results?
Protocol registration and results refer to the process of registering a research protocol before conducting a study and reporting the results after the study is completed.
Who is required to file protocol registration and results?
Researchers and organizations conducting clinical trials are required to file protocol registration and results.
How to fill out protocol registration and results?
Protocol registration and results can be filled out through online portals provided by regulatory agencies or journals.
What is the purpose of protocol registration and results?
The purpose of protocol registration and results is to increase transparency in research, prevent selective reporting of results, and reduce publication bias.
What information must be reported on protocol registration and results?
Information such as study objectives, methods, sample size, outcome measures, statistical analysis plan, and results must be reported on protocol registration and results.
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