Set light in a Clinical Trial Agreement Template - Online Editor

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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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What is a letter of indemnification in clinical research?

A letter issued by a for-profit entity which promises by written confirmation to act as a 3rd-party on behalf of the first party in a transaction or contract.

What is a CTA in pharma?

A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authority(ies) for obtaining authorization to conduct a clinical trial in a specific country. It is an application with necessary information on investigational medicinal products.

What is indemnification in clinical trials?

Indemnity: a promise made by one party to another that it will cover any loss suffered by the other party. Clinical trials sites take out insurance or indemnity arrangements to protect them against liabilities that may arise of part of their clinical trials activities.

What is indemnification in healthcare?

In a contract between a physician and a hospital or contract management group, the intent of an indemnification agreement is to protect the interests of the employer which is often named as a co- defendant in a malpractice lawsuit against a physician.

What is an ACTA contract?

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.

What is an accelerated clinical trial agreement?

[The Accelerated Clinical Trial Agreement (ACTA) was developed to create a standard agreement to accelerate the contracting process between Sponsors and entities registered to use the ACTA.

What is the purpose of the letter of indemnity?

A letter of indemnity (LOI) is a legal agreement that renders one or both parties to a contract harmless in case of delinquency or bdocHub of a contract. The party or parties are indemnified against a possible loss by some third party, such as an insurance company.

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 does a clinical trial assistant do?

As a Clinical Trial Assistant (CTA) you have to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.

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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