Category: A

Auditor

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

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Arm

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

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Adverse Event

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

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ADME Study

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

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Adaptive Clinical Trial

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

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Approval Letter

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

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Applicant

“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

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Annual Report

[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.

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Annotated ECG waveform data

“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.”

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Analysis Datasets

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

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Analysis Data Model (AdAM)

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,

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Amendment

“[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

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Adjuvant

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

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Abridged Application

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

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Adverse Drug Reaction (ADR)

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

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Adverse Event (AE)

Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users, or other persons whether

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