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Replace Radio Button from the Clinical Trial Agreement

Replace Radio Button from the Clinical Trial Agreement and eSign it in minutes

Aug 6th, 2022

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How to Replace Radio Button from the Clinical Trial Agreement

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this video outlines in short how to make changes to an application dossier in the context of a response to a request for information or rfi how to save and view the changes on the application and how to view the other drafts of the application in the evaluation section of the trial page you can see two rfis related to the validation of the trial use the arrows to expand the working area of the first rfi and click on the lock button to be able to work on this rfi and respond to it if for the rfi response you need to change the application based on the contextual information provided in the rfi click on the change application button and then on the confirm button a green message appears on the upper right corner informing you that a new version of the application is being drafted on top below the trial title the blue colored ribbon informs you that a new version has been drafted you can have an application version open in draft mode to address one rfi at a time received in each section s

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Got questions?

Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

What is a clinical trial agreement?

A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.

What are the components of a clinical trial agreement?

A CTA should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract and possibility of

Who develops clinical trial agreement?

This type of agreement can be initiated by either a sponsor or investigator. A sponsor initiated clinical trial agreement is required when the drug or device to be studied has funding provided.

What is the clinical trial agreement?

A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication and input into further

Who prepares essential documents in clinical trials?

The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

What is needed for a CTA submission?

For a CTA, the four main documents are the protocol, informed consent form, IB, and Investigational Medicinal Product Dossier (IMPD), which contains CMC data.

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