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An interface is easy to understand. Eraser and blackout options allow to be HIPAA compliant.
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disappearing buttons from time to time
What problems are you solving with the product? What benefits have you realized?
electronic signature. Go Paperless!
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2021-02-16
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2021-01-19
Modify Table in Clinical Trial Agreement Template
The Modify Table feature in the Clinical Trial Agreement Template empowers you to easily adjust key elements in your agreement. With this tool, you maintain control over your trial setup and ensure accuracy throughout the process.
Key Features
User-friendly interface for quick modifications
Real-time updates to ensure agreement accuracy
Customizable fields to meet specific trial needs
Version tracking to maintain changes history
Secure access for team collaboration
Potential Use Cases and Benefits
Adapt agreements to changing trial conditions
Facilitate stakeholder discussions with clear modifications
Reduce errors with streamlined editing processes
Enhance compliance with updated protocols
Save time on agreement reviews through timely adjustments
This feature addresses your challenges by allowing you to make necessary changes efficiently. Whether you need to update timelines, modify participant details, or adjust funding allocations, the Modify Table feature simplifies these tasks. You can focus on what matters most: conducting a successful clinical trial.
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What information should be included in a clinical trial protocol?
ing to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: Title Page (General Information) Background Information. Objectives/Purpose. Study Design. Selection and Exclusion of Subjects. Treatment of Subjects. Assessment of Efficacy. Assessment of Safety.
What are the components of a clinical trial agreement?
Clinical Trial Agreements typically involve a trial sponsor (a pharmaceutical, biotech, or medical device company), a research institution and a principal investigator. Separate agreements are negotiated in their entirety for each clinical trial.
What is a clinical trial amendment?
Amendments are changes made to a clinical trial after it has received regulatory approval. An amendment can take a significant amount of time and resources to develop, review and implement at participating sites. This can affect the efficient delivery of clinical trials and potentially contribute to research waste.
What is the content of CRF in clinical trials?
Most commonly used standard CRF templates are inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication and study outcome modules, whereas, the modules which captures efficacy data are not unique. Their design varies from study to study depending on the protocol specifications.
What is included in 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 basic components of an agreement?
Whether a contract is 200 pages or 10 pages, to be a legally binding agreement they must contain six basic elements: Offer, Acceptance, Awareness, Consideration, Capacity, Legality.
What is a Phase 1 trial?
The first step in testing a new treatment in humans. A phase I clinical trial tests the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment (for example, by mouth, infusion into a vein, or injection) and how the treatment affects the body.
What is an accelerated clinical trial agreement?
The University of Michigan (along with other industry partners and institutions) uses the Accelerated Clinical Trial Agreement (ACTA). For those industry partners who agree to use the agreement (and the sponsor must agree to use it), it decreases contract negotiation time.
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