What is a Letter of indemnification in clinical research?

Indemnification is a contractual agreement between the parties whereby one party, the indemnifying party, agrees to protect the other party, the indemnified party, against harms or losses brought by a third party that the indemnified party may incur.

How do I write an indemnity Letter?

Title the letter as a “Letter of Indemnity” to make it clear what the document is about. Include a statement that the agreement will be governed by the laws of the specific state (where the agreement would be taken to court). Begin the letter confirming the contract already in place with the other party.

What is an indemnification Letter?

What Is a Letter of Indemnity? A letter of indemnity (LOI) is a contractual document that guarantees certain provisions will be met between two parties. The concept of indemnity has to do with holding someone harmless, and a letter of indemnity outlines the specific measures that will be used to hold a party harmless.

Do indemnification clauses hold up in court?

Court will not enforce an indemnification provision that indemnifies an indemnitee for its own negligence “unless the intention of the parties is clearly and unambiguously expressed.” Courts first look for specific language in the contract that address the fault or negligence of the indemnitee.

What is clinical trial indemnity?

Indemnity is one of the risk management measures for clinical trials. The purpose of an indemnity arrangement is to provide legal protection for the participants in the event of an unforeseen adverse circumstance arising during the course of a clinical trial.

Does a letter of indemnity need to be witnessed?

The Indemnity can be signed by: – Two directors or authorised signatories stating their capacity – One director of the company and a witness. The witness must also provide their full name and address.

WHO issues Letter of indemnity?

Introduction to Letter of Indemnity Typically, these letters are prepared and drafted by a third-party institution, such as banks and insurers, who agree to compensate either of the party when the other party fails to meet the terms of the contract.

What happens if there is no indemnification clause?

If there is no indemnification clause, then the parties will not be entitled to any contractual indemnification. This does not mean that a party may not be held liable towards another party in a court of law, it just means that contractually a party cannot claim compensation for specific damages or expenses.

What is the difference between indemnification and hold harmless?

The main difference in this case is that “hold harmless” may require a party to protect against actual losses as well as potential losses while indemnification protects against actual losses only.

What is clinical trial insurance?

Clinical Trials insurance is specific and personal to the trial or trials. Underwriters limit coverage to the specified trials of listed products and for no other tests or products. As such, the application process is very important. Clarity and specificity are the key.

What is indemnity in research?

2.1 Indemnity The provision of indemnity is the obligation to pay for any loss or damage that has been or might be incurred by an individual, in this case whilst participating in a research study.