A branch of computer science dedicated to creating systems capable of performing tasks that typically require human intelligence. These tasks include learning, decision-making, problem-solving, and

A statistical method for making comparisons between groups, whiletaking into account different variables measured at the start of atrial. It is a form of multiple

An identified risk associated with the use of medicinal products which requires urgent measures to protect patients. Source: (CIOMS VIII: Signal detection 2010)

A tool that assesses the methodological rigour and transparency in which a guideline is developed. Source: (CIOMS XI: Patient involvement 2022)

One of 5 dimensions in the RE-AIM evaluation model (Reach, Efficacy, Adoption, Implementation, Maintenance). Adoption refers to the participation rate and representativeness of both the

A risk minimisation measure which is in addition to the routine risk minimisation activities which apply to all medicinal products in a particular region or

A system for the collection of case safety information as a continuous pre-organized process. Active surveillance can be: Source: (CIOMS DILI 2020)

The degree of risk (likelihood of an adverse event or outcome) that a person or group is prepared to take or considers reasonable. However, what

The environment or community concerned with research, education, and scholarship. Source: (CIOMS XI: Patient involvement 2022)

The number of people in a group who experience an adverse effect divided by the number in that group who could experience that adverse effect.

Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.

Events linked via one or multiple factors (i.e. chronology) but not necessarily having a cause and effect relationship.

A noteworthy event for a product or class of products that a sponsor wants to monitor carefully. It can be serious or non-serious, or it

An agent of a sponsor or CRO who requires access to the TMF for an internal inspection.

A declaration of confirmation by the auditor that an audit has taken place. Source: ICH E6

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial’s protocol. Source: Clinicaltrials.gov

1. An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount

A study characterizing absorption, distribution, metabolism, and excretion (ADME) properties help to explore and explain how pharmacokinetic processes happen, so as to provide safety considerations

Clinical trial design that uses accumulating data to decide on how to modify aspects of the study as it continues, without undermining the validity and

This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD)

[FDA] A written communication to an applicant from FDA approving an application or an abbreviated application. Source: 21 CFR 314.3(b)

“A pharmaceutical company or its agent that is submitting information in support of an application.” Source: Harmonised Technical Guidance for eCTD Submissions in the EU

[FDA] Post-NDA report (submission) providing the FDA with a summary of new research data, distribution information and labeling changes plus certain other information form manufacturers.

“Annotated ECG waveform data are raw voltage-versus-time data comprising the electrocardiogram recording, to which have been attached the identification of various intervals or other features.”

An annotated case report form (CRF) is a blank CRF with annotations that document the location of the data with the corresponding names of the

The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines that is maintained by the World Health Organisation (WHO). The WHO

Analysis datasets are datasets created to support results presented in study reports, the ISS and the ISE and to support other analyses that enable a

ADaM defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data,

“[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally

An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s

Documentation providing detailed information on the manufacturing of the active substance of a medicine. Source: Electronic Active Substance Master Files (eASMF)

The substance responsible for the activity of a medicine. See Drug Stubstance.

Active Pharmaceutical Ingredients (API) refers to an active ingredient that is contained in the medication. See Drug Stubstance.

Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the

An ANDA (ANDA) is an abbreviated version of an New Drug Application (NDA). It is allowed for duplicates of drug products that were first approved

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug Reaction: The detection, assessment, understanding