Clinical Consent Form

The medical field is like a vast sea and is tremendously increasing in size with new discoveries being made every day. Yet a lot of undiscovered mysteries, hidden in the Universe, are needed to be found for the betterment of societies. Medical research has been advancing with the help of clinical trials being conducted at different institutions.

A clinical trial is a research study that is conducted in a specific population to identify the effectiveness and risks of medical, surgical or pharmaceutical intervention.

Types of Clinical Trials

There are two types of clinical research studies that are being conducted throughout the World. These are:

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  1. Observational clinical trials – These clinical trials are conducted by monitoring the participants’ health over a specified period of time. There is no testing of drugs or treatments.
  2. Interventional clinical trials – These are conducted to identify efficacy, safety, and risks associated with a drug or a treatment method. There is usually a comparison made between health changes in groups of participants receiving a particular drug with the other group of participants who are receiving a placebo drug instead.

Classification of Clinical Trials

  • Preventive trials
  • Screening trials
  • Diagnostic trials
  • Treatment trials
  • Epidemiological trials
  • Genetic trials

Phases of Clinical Trials

Phase 0 – in this phase patients are given a minimal amount of dose of drug under test in order to check the pharmacodynamics (how the drug affects the patient) and pharmacokinetics (the reaction of patient’s body toward the drug) of the drug.

Phase 1 – evaluation of safety and safe dose of the drug in a small group of participants

Phase 2 – testing in a larger group of participants

Phase 3 – test is conducted for confirmation in a larger population

Phase 4 – studies are continued after the marketing of the drug

Clinical Consent Form

  • Name of the organization conducting the research study
  • Names of the investigator and sponsor
  • Introduction of the clinical trial
  • Purpose of the study
  • Study procedure and methods
  • Contact information of staff related to study and ethical review committee
  • A complete description of the pros and cons of the study
  • Complications and side effects of the trial
  • Costs and expenses of the trial
  • Rights of the volunteers: Participation must not be forced and each participant is allowed to ask questions regarding the trial before signing. Subjects are allowed to leave the trial or refuse treatment at any point during the trial they want, without losing the benefits they are achieving from the participation
  • Name of the participant and signature. Contact information and address
  • Name, credentials, and signature of the doctor
  • Date of the start of clinical trial

Revision of Clinical Consent Form

Clinical consent forms must be revised whenever new safety guidelines are available or when there is a modification in the trail method or compensation. After approval from the regulatory authority, it must be shared with all the involved trial participants, who in return must sign the revised form.



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Simi Karton

Dr. Simi Karton is a regular contributor to National Science Quarterly and an enthusiastic Lakers fan. She recently collaborated on a manuscript with friends and colleagues. Dr. Simi Karton, entitled Parkinsons and the Genetic Response to Eastern Medicine, in which she and Dr. Inshal presented research compiled during a summer spent in United States. She currently resides in Los Angeles with her husband. This website is a voluntary work of Dr. Karton to provide people with useful health related information stuff at an easy approach. The information has been collected from different sources at one place.

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