Development pharmacovigilance and risk management plan
Plan to conduct the detection, assessment, understanding, reporting and prevention of AEs of medicinal products during clinical trials.
October 24, 2022
Development core safety information (DCSI)
This section of an Investigator’s Brochure (IB) is identical in structure to the CCSI and contains a summary of all relevant safety information (described in
October 24, 2022
Rechallenge
Rechallenge means reintroducing the drug to the patient. A positive rechallenge (the AE reappears) strongly suggests a causal relationship.
October 24, 2022
Dechallenge
Dechallenge is the withdrawal of a drug from a patient to observe: The continuity of an AE (negative dechallenge – causal relationship less likely) The
October 24, 2022
Data Monitoring Committee
Synonyms: Independent Data Monitoring Committee, Data and Safety Monitoring Board This committee is established by the sponsor to: Assess the progress of a clinical trial,
October 24, 2022
Causal Relationship
The causal relationship between an AE and a suspected drug can be, according to the WHO: certain– sufficient information provided to determine that no other reasonable explanation exists,
October 24, 2022
Critical Terms
“Critical Terms” in WHOART refer to or might indicate serious disease states and warrant special attention.
October 24, 2022
Clinical Development Program
Refers to all clinical trials being conducted with the same investigational drug.
October 24, 2022
Council for International Organizations of Medical Sciences (CIOMS)
The CIOMS is a body set up under WHO and UNESCO. It has developed the following pharmacovigilance guidelines:
October 24, 2022
Company Core Data Sheet (CCDS)
Document prepared by the MAH containing the medicinal product’s: Safety information Indications, dosing Pharmacology and other information concerning the product.
October 24, 2022
Company Core Safety Information (CCSI)
All safety information contained in the core data sheet prepared by the medicinal product MAH and which the MAH requires to be listed in all
October 24, 2022
Causality Assessment
Method for assigning probability to the likelihood of a causal relationship between an AE and a suspected drug; according to established algorithms.
October 24, 2022
Case Reports
Individual reports of the experience of single patients, or patients managed as group. At minimum, an adverse event case report must have a reporter, product,
October 24, 2022
Benefit-Risk Balance (Effectiveness/Risk)
An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks (quality, safety, or efficacy) of the medicinal product for
October 24, 2022
Benefit-Risk Assessments
Analysis of the favorable (beneficial) and unfavorable results of doing specific actions. Also called “benefit-harm” or “effectiveness-risk” analysis
October 24, 2022
October 24, 2022
Association
Events linked via one or multiple factors (i.e. chronology) but not necessarily having a cause and effect relationship.
October 24, 2022
Aggregate reports
Reports of a set of cases, meant for regulatory authorities. Annual Safety Report (ASR): In clinical trials, an annual report of all newly available safety information.
October 24, 2022
Adverse Event of Special Interest (AESI)
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
October 24, 2022
Uncontrolled Study
A clinical study that lacks a comparison (i.e., a control) group. Source: NCI
August 31, 2022
TMF Reference Model
A de facto industry standard that provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.
August 31, 2022
Subject Number
A unique number assigned to each participant who enrolls into a clinical trial.
August 31, 2022
Subject
“1. An individual (either a healthy volunteer or a patient volunteer) whose reactions or responses to certain interventions are evaluated during a clinical trial. May
August 31, 2022
Subinvestigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to
August 31, 2022
Study Coordinator
Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and
August 31, 2022
Single-Blind Research Design
A study in which one party, either the investigator or participant, is unaware of what medication or intervention the participant is taking; also called single-masked
August 31, 2022
Screening
A process of active evaluation of potential participants for enrollment in a trial. After a patient is recruited, screening occurs during the enrollment period to
August 31, 2022
SAS Transport Files
The SAS Version 5 (V5) transport file format is an open standard developed by SAS to support data transfers between systems, especially those running different
August 31, 2022
SAS
SAS (previously “Statistical Analysis System”) is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation,[2]
August 31, 2022
Recruitment
Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the
August 31, 2022
Real World Studies
Real-world studies seek to provide a line of complementary evidence to that provided by randomized controlled trials (RCTs). While RCTs provide evidence of efficacy, real-world
August 31, 2022
Randomized Allocation
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. Source: Clinicaltrials.gov
August 31, 2022
Randomization
The process of assigning trial subjects to investigational treatment or control groups (may use a comparator) using an element of chance to determine the assignments
August 31, 2022
Query
A question raised about a data point in a CRF, which may or may not result in a correction. Note: this may also refer to
August 31, 2022
Protocol Deviation
Any change, divergence, or departure from the study design or procedures defined in the protocol Source: ICH
August 31, 2022
Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol. Source: ICH E6
August 31, 2022
Protocol
The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.
August 31, 2022
Principal Investigator
The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site. In most cases the principal
August 31, 2022
Placebo
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
August 31, 2022
Pivotal Clinical Trial
A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities.
August 31, 2022
Phase 4
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that
August 31, 2022
Phase 3
A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages
August 31, 2022
Phase 2
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that
August 31, 2022
Phase 1
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the
August 31, 2022
Phase 0 (aka Early Phase 1)
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body.
August 31, 2022
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The
August 31, 2022
Pharmacokinetics
The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. Source: NLM
August 31, 2022
Patient Registry
A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in
August 31, 2022
Orphan Drug
A drug used to treat, prevent, or diagnose an orphan disease. An orphan disease is a rare disease or condition that affects fewer than 200,000
August 31, 2022
Observational Study
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may
August 31, 2022
NCT Number
ClinicalTrials.gov identifier – The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number
August 31, 2022
Multicenter Trial
A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out bymore than one investigator. Source: FDA
August 31, 2022
Monitoring Visit Report
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. Source: ICH E6
August 31, 2022
Monitoring Visit
An oversight visit to a clinical trial site to review the progress of the study and ensure protocol adherence, accuracy of data, safety of subjects
August 31, 2022
Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol,
August 31, 2022
Lost to Follow Up
The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. Source: FDA Glossary
August 31, 2022
Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator. Source: Clinicaltrials.gov
August 31, 2022
Investigational Site
A site at which clinical research is conducted, usually associated with a hospital or university.
August 31, 2022
August 31, 2022
Investigational New Drug Application (IND)
A request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product
August 31, 2022
Investigational Drug
The drug being evaluated in the trial; this definition is synonymous with “investigational new drug” or “investigational medicinal product.”
August 31, 2022
Interventional Study (Clinical Trial)
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can
August 31, 2022
Interim Analysis
Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. Source:
August 31, 2022
Institutional Review Board (IRB)
An IRB (also known as an independent ethics committee (IEC), ethical review board (ERB) or research ethics board (REB)) is a group of doctors, scientists,
August 31, 2022
August 31, 2022
Inspection
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies)
August 31, 2022
Informed consent form (ICF)
The document used in the informed consent or process. [Note that there is a “model informed consent” master document and an executed informed consent that
August 31, 2022
Informed Consent
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects
August 31, 2022
Independent Ethics Committee
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is
August 31, 2022
Inclusion Criteria
A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. Source: Clinicaltrials.gov
August 31, 2022
Important Protocol Deviation
A subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject’s
August 31, 2022
Health Authority (HA)
A national or international health agency that has authority over and regulates a clinical study
August 31, 2022
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results
August 31, 2022
Exclusion Criteria
A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. Source: Clinicaltrials.gov
August 31, 2022
Enrollment
The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study. Source:
August 31, 2022
Endpoint
Principal indicator(s) used for assessing the primary question (i.e., hypothesis) of a clinical trial. A variable that pertains to the efficacy or safety evaluations of
August 31, 2022
Patient-Reported Outcome (PRO)
An outcome based on a report that comes directly from the patient about the status of a patient’s health condition without amendment or interpretation of
August 31, 2022
Electronic Patient Reported Outcome (ePRO)
See Patient-Reported Outcome (PRO) – ePRO collects this information electronically with an app, wearable, web page, etc.
August 31, 2022
August 31, 2022
Dropout
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the
August 31, 2022
Double-Blind Research Design
A study in which neither the participant nor the researcher knows whether the participant is in the treatment or control groups. Source: FDA Patient Glossary
August 31, 2022
Dose-Ranging Study
A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose
August 31, 2022
August 31, 2022
Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the
August 31, 2022
Crossover Study
A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by
August 31, 2022
Corrective And Preventative Action (CAPA)
Improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations, or steps taken to mitigate the results of a non-conformity.
August 31, 2022
Controlled Study
A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. Source: NCI
August 31, 2022
Control
The control or “standard” treatment is compared against the investigational treatment. It is there to show that an approved treatment in the trial works, and
August 31, 2022
Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions
August 31, 2022
Comparator
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Source: ICH E6
August 31, 2022
Combination Product
1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit.
August 31, 2022
Clinicaltrials.gov
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health.
August 31, 2022
Clinical Trial Authorization (CTA)
A submission filed with the Medicines & Healthcare Products Regulatory Agency or EMEA as necessary to commence human clinical trials of a drug in conformance
August 31, 2022
Clinical Study Report
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations,
August 31, 2022
Clinical Study
A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional
August 31, 2022
Certified Copy
A copy of original information that has been verified as having the same metadata and data as the original. The copy may be verified by
August 31, 2022
Case Report Form
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. NOTE:
August 31, 2022
Blinding / Masking
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which
August 31, 2022
Bioavailability
The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance
August 31, 2022
Auditor
An agent of a sponsor or CRO who requires access to the TMF for an internal inspection.
August 31, 2022
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