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A website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a package insert) to health care providers and the general public. The contents of DailyMed are provided and updated daily by the U.S. FDA. The FDA, in turn, collects this information from the pharmaceutical industry.

For more information, visit the DailyMed official website.

In the clinical trial industry, a process is used before the end of the study to confirm the receipt and accuracy of data collected via EDC during a study.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A warehouse that is used to store and distribute items (drugs) to another destination (other depots or sites).

An integration type based on which the system extracts the dispatch file on the depot shipments from the vendor's server into IWRS for data exchange and analysis purposes.

In eClinical, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

In IWRS, a set of items to be dispensed (given) to a particular subject in a course of their treatment.

A plan that outlines the procedures for administering a particular drug or treatment to subjects in a clinical trial during corresponding dispensing visits.

In eClinical, a subject visit to a site at which they receive their dispensing packages (medications) in the course of a clinical trial.

A specific time frame during which the dispensing visit can occur so that the dispensing package is administered to the subject timely according to their treatment plan.

In eCLinical, a status of an item (drug) or a subject (study participant) that represents the current state or stage of participation in a trial.

See also: item disposition

A specific area or category of data within a clinical trial that encompasses a set of related variables that share a common theme. Each domain organizes data to facilitate analysis and reporting, ensuring that information is structured and easily interpretable.

A non-profit association that enables knowledge exchange and collaboration for the companies involved in healthcare product development.

Learn more about DIA on its official website.

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.

A model for organizations from DIA that provides a standard taxonomy and metadata of TMF content.

A randomization method that adjusts the allocation probabilities based on the current distribution of participants. Thus, when each subject comes to the study, the system assesses their compliance with established factors, evaluates the existing patient groups and site imbalance, and allocates the new patient to the most imbalanced group. Unlike permuted block randomization, dynamic randomization does not involve the predefined randomization list and offers more adaptivity to achieve arm balance at all times.