Clinical Trial Documentation – Informed Consent Document

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Clinical Trial Documentation – Informed Consent Document

Informed consent Document (ICD)

Informed consent is one of the most essential document ensuring the ethics of medical experiments and protection of the rights of the study subjects. Subjects must sign before participating in a clinical research study. 

The subject should be informed of the following:

  • The purposes of the trial;
  • The methods of the trial;
  • The study drug(s) and treatment regimens;
  • Available alternative treatment(s);
  • The potential risks and benefits, and possible discomforts.

The subject should understand:

  • That informed consent should be given freely;
  • That consent should not be obtained through inducement or coercion;
  • That he/she may withdraw from the study at any time;
  • That withdrawal from the study will not affect his/her future medical care.

Additional Elements

  • Description of the level of confidentiality;
  • Costs or expenses associated with participation in the study, including study-related injuries;
  • Contact information for questions concerning the study or a research-related injury.

Other information may be included if the clinical investigator, the sponsor, and/or the IRB/REB believe that the information is needed to better inform and assist subjects in the decision-making process.

Informed Consent Form should be written at a 6th grade reading level or lower, which means:

  • Sentences and paragraphs are short,
  • Terms and concepts are simple, and
  • Technical information is explained in non-technical ways.

Information should be accurate and precise. The consent form should be easy to look at.

Subject voluntary or legally authorized representative confirms his/her willingness to participate in the study by signing the form. A copy of the signed informed consent form will be given for personal records and as a reference tool throughout the study.

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