Structure case study

This document describes the definitions for protocol registration data elements submitted to for interventional studies (clinical trials) and observational studies. These definitions are mostly adapted from 42 CFR Part 11 . Data element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials . Note : The term "clinical study" is used to refer to both interventional and observational studies. The term "participant" is used to refer to human subjects.
*   Required * §   Required if Study Start Date is on or after January 18, 2017 [*]   Conditionally required

1. Study Identification

  • Unique Protocol Identification Number *
    Definition: Any unique identifier assigned to the protocol by the sponsor.
    Limit: 30 characters.
    Brief Title *
    Definition: A short title of the clinical study written in language intended for the lay public. The title should include, where possible, information on the participants, condition being evaluated, and intervention(s) studied.
    Limit: 300 characters.
    Acronym [*]
    Definition: An acronym or abbreviation used publicly to identify the clinical study, if any.
    Limit: 14 characters.
    Official Title * §
    Definition: The title of the clinical study, corresponding to the title of the protocol.
    Limit: 600 characters.
    Secondary IDs [*]
    Definition: An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Number or the NCT number that is assigned to the clinical study. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries. If the clinical study is funded in whole or in part by a . Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID.
    Limit: 30 characters. If there is a Secondary ID, then the following information must be provided:

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    With AWS cloud services’ many features and AWS Professional Services, IGG successfully achieved the “nearly unattainable goal” of establishing an active-active disaster recovery center which enables real-time synchronization and backup of core operations at two separate locations. Founded in 2005, IGG is a world leading mobile game developer and publisher who provide games and game-related services worldwide. Currently, AWS products are integrated into every business line of IGG; these products include Amazon EC2, Amazon S3, Elastic Load Balancing, Auto Scaling, Amazon CloudWatch, Amazon Route 53, Amazon DynamoDB, Amazon VPC, etc. 

    There is a hope to change the current situation, though. According to Debra Pryor and Nancy Nelson Knupfer (1997), “If we become aware of the stereotypes and teach critical viewing skills to our children, perhaps we will become informed viewers instead of manipulated consumers”. Moreover, the commercials evolve along with the development of a society and are the answer to many social and political changes, such as emancipation of women, growing role of individualism, globalization and revaluation of patterns and social roles.  More and more advertising specialists produce non-stereotypical commercials. However, the attempts to break down the stereotypes threaten to reject the message; they affect security and well-established knowledge about the world. Hence, a society has to achieve an adequate level of social readiness, so that messages breaking gender stereotypes could be effective.

    Structure case study

    structure case study

    There is a hope to change the current situation, though. According to Debra Pryor and Nancy Nelson Knupfer (1997), “If we become aware of the stereotypes and teach critical viewing skills to our children, perhaps we will become informed viewers instead of manipulated consumers”. Moreover, the commercials evolve along with the development of a society and are the answer to many social and political changes, such as emancipation of women, growing role of individualism, globalization and revaluation of patterns and social roles.  More and more advertising specialists produce non-stereotypical commercials. However, the attempts to break down the stereotypes threaten to reject the message; they affect security and well-established knowledge about the world. Hence, a society has to achieve an adequate level of social readiness, so that messages breaking gender stereotypes could be effective.

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