Insert image in the Clinical Trial Agreement Template

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How to Insert image in the Clinical Trial Agreement Template

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um Im excited today to kick off the fall clinical trials toolkit series um our first one is the office of sponsored programs clinical trial agreement review and negotiation um today we have Rachel humberson she is the interim assistant director um from research office and office of sponsored programs and we also have um Julie even though I practiced it Julie Im going to mess it up Anna okay is that right yeah okay she is a negotiator with research with the research office and office of sponsored programs um before I read their um their bios and a fun fact about them again we are offering continuing education to WVU employees so if um you would like CES please indicate that and please put your name um an email address in the chat so for attendance purposes um Im trying to think if theres anything else oh if you have a question during this um feel free to put it in the chat well be watching it and um I will stop Rachel and Julie and let them know what your question is and then also

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What do clinical trial agreements look like?

Clinical Trial Agreement (CTA) Description of the Project. Sponsor, CRO (Contract Research Organization) and Site Responsibilities. Publication and Intellectual Property Terms. Indemnification and Insurance. Recording Keeping and Inspection. Guidelines for Dispute Resolution. Grounds for Contract Termination.

What are clinical trial agreements?

International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidance defines essential documents as those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.

What are the parts of a clinical trial agreement?

Definition. 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 essential documents in clinical trials?

Study protocols PROSPERO. PROSPERO is an international database containing protocols of systematic reviews with a health-related outcome. Find more information about PROSPERO here. ClinicalTrials.gov. ClinicalTrials.gov is a database of clinical studies conducted around the world.

What does a clinical trial protocol look like?

A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. The protocol also outlines steps for protecting subjects and obtaining quality data.

What are examples of clinical trial source documents?

Common source documents are participant medical records, phone encounters or notes, lab and diagnostic test results, participant diaries and specific research worksheets used to document key research data elements.

Is a clinical trial agreement a contract?

CTAs are one of several key documents that govern the conduct of clinical trials. 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.

What is a clinical trial agreement between CRO and site?

The Trial Site will permit the Sponsor and CRO to examine the conduct of the Clinical Trial and the Investigator Site upon reasonable advance notice during regular business hours to determine that the Clinical Trial is being conducted in ance with the Protocol, ICH-GCP and the applicable regulatory requirements.

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Insert image in the Clinical Trial Agreement Template effortlessly