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How to Send Clinical Trial Agreement Template

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The video tutorial introduces the fall clinical trials toolkit series, starting with a session on clinical trial agreement review and negotiation. Presenters include Rachel Humberson, interim assistant director of the research office and office of sponsored programs, and Julie Anna, a negotiator from the same office. Viewers are informed that continuing education credits are available for WVU employees and are encouraged to provide their name and email in the chat for attendance. Questions can also be submitted in the chat for Rachel and Julie to address during the session.

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What is a trial template?

A trial template is a template for creating trials: its a trial thats partially complete, with some values (represented by variables) to be added in later. During script evaluation, PennController fills in the variables with values from a specified table.

How do I create a study protocol template?

Always number the pages of your protocol and indicate the version date in the header or footer. PROJECT TITLE. Title of the study (including acronym and lay title) INVESTIGATORS. RATIONALE / BACKGROUND. AIMS / OBJECTIVES / HYPOTHESES. PARTICIPATING SITES. STUDY DESIGN. STUDY OUTLINE. ETHICAL CONSIDERATIONS.

What is included in a clinical trial agreement?

A clinical trials agreement 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

How do I submit a clinical trial?

To register your clinical trial: Check to see whether your organization already has a PRS organization account . Apply for a PRS account. See how to apply for an account on ClinicalTrials.gov. Logon to PRS on the PRS Login Page . Enter the required and optional data elements. Preview, inspect, and submit the record.

What is a clinical trial protocol?

The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

Is a clinical trial agreement the same as a contract?

A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each partys responsibilities and obligations for the clinical trial.

How do you write a clinical trial protocol?

6) Methods and Materials: It should describe in detail the Where, Who, How the research will be conducted. It explains the study design and procedures and techniques used to achieve the proposed objectives. It defines the variables and demonstrates in detail how the variables will be measured.

What is clinical trial protocol template?

This Clinical Trial Protocol Template is a suggested format for Phase 2 or 3 clinical trials supported by the National Institutes of Health (NIH) that are being conducted under a Food and Drug Administration (FDA) Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).

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