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How to Fax Clinical Trial Agreement

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The fall clinical trials toolkit series is kicking off with a focus on the Office of Sponsored Programs (OSP) and clinical trial agreement review and negotiation. The session features Rachel Humberson, the interim assistant director from the research office, and Julie, a negotiator with the OSP. Attendees from WVU are offered continuing education credits, and are encouraged to provide their names and email addresses in the chat for attendance tracking. Participants are also invited to ask questions during the presentation, which will be communicated to the speakers. The event aims to provide valuable insights into clinical trial agreements.

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What is the purpose of a clinical trial agreement?

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 are the components of a clinical trial agreement?

Clinical Trial Agreement (CTA) Description of the Project. Sponsor, CRO (Contract Research Organization) and Site Responsibilities. Publication and Intellectual Property Terms. Indemnification and Insurance.

What is considered a source document in clinical research?

Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being

What are examples of source documents in clinical trials?

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 CRF a source document?

Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated in the protocol; however, it should not be general practice for all data collected during a clinical trial.

What is a CTA agreement?

Contractor Team Arrangement means a Federal Supply Schedule Contractor Team Arrangement (CTA) where an arrangement is established between two or more Schedule contractors who work together to meet agency requirements.

How do you write a clinical trial agreement?

9 Essential Components of a Clinical Trial Agreement Description of the Project. Payment Terms and Schedule. Sponsor, CRO and Site Responsibilities. Publication and Intellectual Property (IP) Terms. Indemnification and Insurance. Recordkeeping and Inspection. Guidelines for Dispute Resolution. Grounds for Contract Termination.

What are the examples of source documents?

Some examples of source documents include: Bank Statements. Payroll Reports. Invoices. Leases Contracts. Check Registers. Purchase Orders. Deposit Slips not included on a bank statement. Check Copies not included on a bank statement.

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

What are the essential documents to be generated after completion or termination of the clinical trial?

Essential Study Documents Overview Study Protocol signed, dated by all entities (PI, sponsor) Study Protocol Amendments. Informed Consent. IRB Approval(s) Delegate of Authority and Log of Responsibilities. Curriculum Vitae (CVs) current. Financial Disclosures. Protocol Training Documentation.

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Fax Clinical Trial Agreement