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A document used to track the distribution, collection, and status of Informed Consent Forms (ICFs) from participants in the trial. It is a management tool that ensures proper documentation and completion of all steps related to informed consent throughout the trial process.

An ICH standard of electronic transmission of individual case safety reports (ICSRs) data elements and message specification that must be incorporated according to ICH's Implementation Guide.

An eClinical application that represents a hub for uploading, storing, and managing medical images, such as MRI, CT scans, and X-rays, collected from trial participants across various sites while facilitating quality checks to ensure compliance with regulatory and study protocol requirements.

These are the key characteristics of the target population that researchers will use to answer their research questions. Typical inclusion criteria include demographic, clinical, and geographic characteristics.

Also known as an Institutional Review Board (IRB), is a formally designated independent body that protects the rights, safety, and well-being of all human subjects involved in a clinical trial.

A specific medical condition or disease for which a pharmaceutical product is intended to be used. It defines the approved or authorized therapeutic uses of the medication as determined by the regulatory authorities based on the product's safety and efficacy data.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial.

A document that provides essential information about a clinical trial to potential participants to ensure their complete understanding of the research nature, the risks and potential benefits involved, and their rights as participants.

Before enrolling in a clinical trial, participants must read and understand the information in the ICF, and signing the ICF indicates their willingness to participate, understanding that they have been fully informed about the study.

A data management, healthcare, software, or another organization that cooperates with the sponsor to provide data or services for a study.

See also: participating organization

Also known as an Independent Ethics Committee (IEC) in the European Union, the Institutional Review Board is a group that is formulated and formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

Get to know all the possibilities of the app with the comprehensive IWRS User Guide.

A set of codes (designations) used by healthcare staff to communicate diseases, symptoms, abnormal findings, and other elements of a patient's diagnosis in a way universally accepted by those in the medical and insurance fields.

A document that recommends how to include the details on a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted on human subjects.

An independent, non-governmental organization whose membership consists of different national standards bodies. The organization develops and publishes international standards in various technical and non-technical fields.

A system of measurement used worldwide. It provides a precise framework to measure the range of quantities. It is based on the following seven base fundamental units, from which the further units are derived:

A pharmaceutical form of active substances or placebos being tested or used as reference in clinical trials.

The number assigned by the FDA to a clinical trial application for an investigational drug in the United States. When a pharmaceutical company or sponsor intends to conduct clinical trials with an investigational drug in the U.S., they must submit an Investigational New Drug (IND) application to the FDA.

A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

A comprehensive document prepared by the sponsor or manufacturer of an investigational drug or medicinal product. It is primarily intended for use by clinical investigators who are conducting clinical trials to evaluate the safety and efficacy of the investigational product.

In CTMS, a finding that is discovered during a monitoring visit at a site and requires resolution. Issues can take many forms, depending on the nature and severity of the finding. An issue may also involve correcting data errors in subject records.

In eClinical, a unit of a drug that is being tested in a clinical trial is referred to as an item.

In IWRS, an item disposition is the status of an item (drug) that represents its current state. For instance, Available, In Transit, Quarantined, and so on.

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the item unit in the IWRS system is product unit.