Name: Type of Study: If you selected OTHER, provide project/study type: --Select-DEVICE trials: Is the sponsor providing the device? Yes No Does the Institution need to purchase the device? If yes, please upload the Purchasing Agreement (required for Feasibility review) Yes No Submission Type: --Select-Protocol Title: Funding Source: If you selected OTHER, please provide funding source: --Select-Sponsor / Funder Name: Sponsor-provided protocol number: IND number (if applicable): IDE.
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How to fill out the UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form online
Filling out the UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form online is a crucial step in initiating your research project. This guide provides detailed instructions to help you navigate each section of the form effectively.
Follow the steps to accurately complete your form online.
- Press the ‘Get Form’ button to access the form and open it in your editor.
- Begin with the study contact section. Fill in your last and first name, phone number, and UA email address.
- In the study overview section, provide the study protocol number or nickname and select the type of study from the dropdown menu.
- If the study type is 'OTHER,' specify the project or study type in the provided field.
- Next, answer the questions regarding device trials. Indicate whether the sponsor will provide the device, and if the institution needs to purchase it, upload the purchasing agreement.
- Complete the submission type and protocol title fields, along with the funding source. If you choose 'OTHER' for funding source, provide a detailed explanation.
- Fill in sponsor information, including the sponsor name and protocol number, if applicable.
- Address the PHI questions by indicating whether PHI will be transferred outside UA or Banner Health, and select the HIPAA methods that apply.
- Provide the principal investigator's information, including their name, email, and type of investigator.
- Fill in anticipated enrollment information such as participant numbers and study visit dates.
- Complete the ClinicalTrials.gov section, including the NCT number if applicable and specify if the study does not need to be registered.
- Provide additional information regarding Banner/Dignity and UA facilities to be used for the study, detailing any specific resources required.
- Complete the medical imaging section, indicating whether medical imaging is being used and if any special arrangements are needed.
- Fill out the study agreement/contract section, providing all relevant contact details for negotiators.
- Lastly, attach any required documents such as the application for human research, research personnel list, and consent forms as prompted.
- Once all sections are completed, review your entries for accuracy before saving changes, and consider downloading, printing, or sharing the form as necessary.
Begin your application process by filling out the UAHS Research Intake Application online today.
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What document is required to enroll research subjects in a clinical research study?
To enroll research subjects in a clinical research study, the informed consent document is required to ensure participants understand the study. This document establishes a mutual agreement between the researcher and the participant regarding the study's procedures and responsibilities. The UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form can help effectively manage the consenting process, ensuring compliance and clarity.
What is an essential document in clinical research?
An essential document in clinical research is one that provides crucial information about the study's conduct and its ethical oversight. This document may include the clinical protocol, investigator's brochure, and reports of previous studies. Utilizing the UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form ensures that all necessary documents are prepared and reviewed systematically, facilitating a smoother research process.
What kind of requirement documents are you familiar with in clinical trials?
In clinical trials, several requirement documents are essential for compliance and effective management. These may include the study protocol, informed consent forms, and IRB approvals. The UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form can assist in organizing these essential documents, making it easier to track compliance throughout the study.
What document must be obtained from a trial subject before participation in a clinical trial?
Before participation in a clinical trial, a document known as the informed consent form must be obtained from each trial subject. This form ensures that participants are aware of the study's risks, benefits, and their rights. Using the UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form can streamline the process of obtaining and documenting informed consent.
Who is responsible for ensuring the ethical conduct of a clinical trial?
The responsibility for ensuring ethical conduct in a clinical trial primarily falls on the principal investigator. This individual ensures that the study adheres to ethical standards and that participants' rights are protected throughout the trial. Utilizing the UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form helps in maintaining transparency and adherence to ethical guidelines.
What is the document used in clinical research?
The document used in clinical research is critical for detailing aspects of the study. It typically outlines the study's objectives, procedures, and participant requirements. The UAHS Research Intake Application New Study Submission/Feasibility Resubmission Form plays a key role in gathering necessary information to initiate clinical trials, ensuring alignment with ethical standards.
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