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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.

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Is clinical trial agreement the same as a contract?

The contract of Clinical Trial Agreement (CTA) (also known as a Clinical Trial Research Agreement [CTRA] or Clinical Study Agreement [CSA]) is a legally valid document that manages the relationship between the body that is providing the study drug or device, the financial support and /or proprietary information and the

What financial considerations should be included in developing a budget for a pharmaceutical company sponsored study?

There are one-time costs that should be included in the budget, if applicable: IRB fees, IRB continuing review fees, IRB amendment fees, investigational drug set-up fees, MCA preparation fee, archive fees, and advertising costs.

What is included in 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.

What are the three components of a clinical trial?

In the case of the clinical trials research enterprise, all three componentsthe medical team, industry, and government/insurancemust function collaboratively and using BAM thinking to meet the needs of the patient.

What is a CTA in a clinical trial?

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 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

What is a clinical trial agreement CTA?

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 the difference between a CTA and IND?

Key Distinctions Between CTAs and INDs One primary distinction to note between a CTA and an IND submission is that the CTA is protocol-specific, while the IND is product-specific. Once the CTA is submitted, the EU requires a new CTA for any new protocols amended.

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