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This document outlines the regulatory process and required preliminary documentation for clinical research studies at VCU, detailing responsibilities for various stakeholders including CRC, RAS, and
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How to fill out VCU Center for Clinical and Translational Research Regulatory Process Preliminary Documentation

01
Gather all relevant project information including research objectives and methodology.
02
Obtain necessary approvals from your institution's review board or ethics committee.
03
Complete the Preliminary Documentation form provided by VCU's Center for Clinical and Translational Research (CCTR).
04
Include detailed information about the study design, participant recruitment strategies, and data collection methods.
05
Clearly outline any risks to participants and how they will be mitigated.
06
Provide information on how the results of the research will be disseminated.
07
Review the completed documentation for accuracy and completeness.
08
Submit the Preliminary Documentation to the CCTR for review and approval.

Who needs VCU Center for Clinical and Translational Research Regulatory Process Preliminary Documentation?

01
Researchers conducting clinical or translational research at Virginia Commonwealth University (VCU).
02
Graduate students and faculty involved in studies requiring regulatory oversight.
03
Anyone seeking to access CCTR resources and facilities for their research projects.
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VCU Center for Clinical and Translational Research Regulatory Process Preliminary Documentation is a set of guidelines and forms that researchers must complete before initiating clinical trials. It outlines the regulatory requirements and ensures that all necessary approvals are obtained to comply with ethical and legal standards.
Researchers and principal investigators conducting clinical trials at VCU or using VCU resources are required to file this documentation to ensure compliance with regulatory standards.
In order to fill out the documentation, researchers must collect relevant project details, including study objectives, methodology, participant information, and potential risks. They should follow the provided guidelines and complete all required sections accurately before submission.
The purpose of this documentation is to facilitate the regulatory approval process for clinical research, ensuring that all ethical considerations are addressed and that the rights and safety of participants are protected.
The documentation must include information such as the study title, principal investigator details, research objectives, methodology, eligibility criteria for participants, informed consent processes, and potential risks and benefits associated with the study.
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