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 the investigational treatment is compared…
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 Source: ICH E6
Comparator
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Source: ICH E6
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. 3. A product that is…
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. ClinicalTrials.gov is a Web-based resource…
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 with applicable laws and regulations.
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, and analyses are fully integrated…
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 studies (also called clinical trials)…
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 dated signature or by a…
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: In common usage, CRF can…
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 participants have been assigned which…
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 that is taken by mouth…
Auditor
An agent of a sponsor or CRO who requires access to the TMF for an internal inspection.
Audit Certificate
A declaration of confirmation by the auditor that an audit has taken place. Source: ICH E6
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
Adverse Event (AE)
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 of time after the study…
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 of a new drug on…
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 integrity of the trial. Source:…
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify and describe medicinal products. The…
Ennov to Exhibit at ICTMC 2022
Ennov will exhibit at the International Clinical Trials Methodology Conference 2022 being held 3-6 October 2022 in Harrogate, England, UK. Ennov is a leading Life Sciences technology vendor with solutions…
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are deliberate and data-driven, and activity…
Ennov to Exhibit at the 2022 World Drug Safety Congress Europe
Ennov will exhibit at the 2022 World Drug Safety Congress Europe being held on 27-29 September 2022 in Amsterdam, RAI Congress Centre. As Europe’s principal Drug Safety & PV Event, the…
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
Ennov to Exhibit at the 2022 RAPS Regulatory Convergence
Ennov will exhibit at the 2022 RAPS Regulatory Convergence conference being held 11-13 September 2022 at the Phoenix Convention Center in Phoenix, AZ. The RAPS Regulatory Convergence is an annual…
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice as many findings in this…
Sponsor Oversight and the Role of eTMF | Webinar
Clinical Webinar Sponsor Oversight and the Role of eTMF Learn how your industry colleagues are conducting TMF oversight and overcoming common challenges.Wednesday, July 20, 11am EDT Save My Spot! What…
Leveraging RIM for DADI and IDMP | Ep 3: Examples of Divergence
Explore concretes examples of divergence between a RIM data model and HA guidance data format.
Leveraging RIM for DADI and IDMP | Ep 2: Enterprise-Level Data Architecture
Learn about enterprise-level data architecture using master level data management.
Leveraging RIM for DADI and IDMP | Ep 1: Best Practices for Data Modeling
Discover the best practices for RIM Data modeling in the context of IDMP.
Ennov and Medical Edge Announce New Partnership
Ennov and Japanese company Medical Edge are pleased to announce a new partnership that will increase the distribution of Ennov’s Quality solution suite to the Japanese market. This partnership further…
eTMF for Risk Management and Regulatory Compliance | Ep. 6: Sponsor Access
Episode 6 of our mini-series explores TMF Sponsor Access for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 5: TMF Inspections
Episode 5 of our mini-series explores TMF Inspections for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 4: TMF Quality
Episode 4 of our mini-series explores TMF Quality for Risk Management & Regulatory Compliance.
Ennov Serves as Global Patient Call Center Platform
Implementation of the Ennov solution resulted in a responsive call center platform to support global patient interactions.
eTMF for Risk Management and Regulatory Compliance | Ep. 3: TMF Timeliness
Episode 3 of our mini-series explores TMF Timeliness for Risk Management & Regulatory Compliance.
Ennov to Exhibit at the 2022 DIA Global Annual Meeting, June 19-23 in Chicago, IL
Ennov is pleased to announce we will be exhibiting at the DIA Annual Meeting being held June 19-23, 2022 at the McCormick Place Convention Center in Chicago, IL. The DIA…
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Episode 2 of our mini-series explores TMF Completeness for Risk Management & Regulatory Compliance.
eTMF for Risk Management and Regulatory Compliance | Ep. 1: Guidance Review
Episode 1 of our mini-series explores TMF Guide Review for Risk Management & Regulatory Compliance.
Worksharing
The submission of a single application for a variation that affects more than one marketing authorisation from the same marketing authorisation holder. Source: Worksharing: questions and answers
WebTrader
[FDA] WebTrader is a Web interface that copies and packages your submission on your desktop in a secure fashion, transmits the submission in a fully encrypted message to the FDA,…
Veterinary Non eCTD Electronic Submission (vNeeS)
VNeeS format is the submission format for veterinary products in the EU.Electronic submission in the VNeeS format is mandatory for submissions to EMA as well as for submissions in the…
Variation
[EMA] a change to the terms of a marketing authorisation. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.…
Universally Unique IDentifier (UUID)
A universally unique identifier (UUID) is a 128-bit label used for information in computer systems. Ex: 123e4567-e89b-12d3-a456-426614174000 In eCTD EU dossiers, the UUID is linking the sequence to the eCTD…
Unique Ingredient Identifier (UNII)
A unique ingredient identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the…
Trade Name
The words, names, slogans, pictures or symbols that are used to identify a company. In common usage, trade name is often used inappropriately for brand name and trademark. This name…
Therapeutic Area
A grouping of similar diseases or conditions under a generalised heading, eg diabetes, oncology, cardiovascular.
Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT)
Systemized NOmenclature of Medicine - Clinical Terms (SNOMED-CT) is the most precise, comprehensive, standardized, multilingual clinical health terminology product in the world, owned and distributed around the world by The…
Supplement
[FDA] A request to FDA to approve a change to an approved license application. See definitions for individual types of supplements. Source: SOPP 8401.2: Administrative Processing of BLA and NDA…
Summary of Product Characteristics (SmPC)
The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms, and known adverse reactions, amongst…
Substance, Product, Organization, Referentials (SPOR)
A Task Force of Industry, NCAs, EMA, and SMEs who advise and provide recommendations on planning, development, implementation, and maintenance of IDMP standards in the EU.
Submission
A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application
Subject Profiles
Subject profiles are displays of study data of various modalities collected for an individual subject and organized by time. Source: Study Data Specifications (FDA)
Study Tagging File (STF)
The Study Tagging File (STF) is an xml file that should be provided with the eCTD submission of any file, or group of files belonging to a study in Modules…
Study Data Tabulation Model (SDTM)
SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates…
Structured Product Labeling (SPL)
The electronic format by which content of labeling should be submitted to the FDA. SPL utilizes Extensible Markup Language (XML). Source: FDA
Statistical Analysis System (SAS)
SAS is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation, and predictive analytics. SAS datasets and other elements are…
Standard for Exchange of Nonclinical Data (SEND)
SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format. SEND is one of the…
Sponsor
ICH: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. According to US 21 CFR 50.3, a corporation or agency…
Sequence Number
The unque four digit number associated with an eCTD sequence, normally beginning with 0000 for the first sequence in an application.
Sequence
A single set of information and / or electronic documents submitted at one particular time by the applicant as a part of, or the complete application .Any collection of content…
Route of Administration
A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the CDER Data…
Rolling Submission
[FDA] In a rolling submission (also known as rolling review), a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review…
Related Sequence
Sequences may be related to one another within one regulatory activity. The related sequence number should always be stated. In case of activities with only one sequence the same sequence…
Regulatory Intelligence
Act of gathering and analyzing regulatory information and monitoring current regulatory climate and using this data to generate creative and innovative regulatory strategies designed to obtain and maintain product approvals…
Regulatory Information Management System (RIM / RIMS)
Regulatory Information Management refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products across the life sciences value chain. Source: DIA - RIM…
Regulatory Affairs
The department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the…
Regulatory Activity
A public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity. An independent regulatory agency is a regulatory…
Regulated Product Submissions (RPS)
A Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. Now generally known as eCTD Version 4.
Reference Member State (RMS)
[EMA] The European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure. Source: EMA Glossary
Reference Listed Drug
[FDA] The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Source: 21 CFR 314.3(b)
Rapporteur
[EMA] One of the two members of a committee or working party who leads the evaluation of an application. Source: EMA Glossary
Quality Overall Summary (QOS)
The Quality Overall Summary (QOS) is a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications
Qualified Person Responsible For Pharmacovigilance (QPPV)
An individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU.
Priority Review
[FDA] Designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, where the time it takes FDA to review a new…
President’s Emergency Plan for AIDS Relief (PEPFAR)
United States governmental initiative to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease.
Predicate Rule
[FDA] A previously published set of rules with the exception of part 11 (such as GLPs, GCP, or cGMPs) that mandate what records must be maintained, the required contents of…
Plasma Master File (PMF)
The plasma master file (PMF) is a compilation of all the required scientific data on the quality and safety of human plasma relevant to the medicines, medical devices and investigational…
Pharmacovigilance Risk Assessment Committee (PRAC)
[EMA] The European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines. Source: Pharmacovigilance Risk Assessment Committee (PRAC)
Pharmacopoeia
A pharmacopoeia is a book describing drugs, chemicals, and medicinal preparations which is issued by an officially recognized authority and serves as a standard.
Pharmaceuticals and Medical Devices Agency (PMDA)
The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.
Patient Package Insert (PPI)
[FDA] Patient labeling that is part of the FDA-approved prescription drug labeling. PPIs are developed by the manufacturer, approved by the FDA, and are required to be dispensed with specific…
Packaged Medicinal Product Identifier (PCID)
[SPOR] Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same Medicinal Product has more than…
Organisation Management Service (OMS)
[SPOR] The OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes. It stores master data…
Novel Excipient
A material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive Ingredient Database (IID)) or that…
Non eCTD Electronic Submission (NeeS)
In general, a submission that uses the eCTD folder structure and file naming conventions but does not include an XML backbone.
Node Extension
Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the eCTD structure and should be…
New Drug Application (NDA)
A New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. Source: New…
Nationally Authorised Product (NAP)
[EMA] A medicine authorised in a Member State in accordance with its national authorisation procedure. Source: Nationally Authorised Product
National Competent Authority (NCA)
[EMA] A medicines regulatory authority in a European Union Member State. Source: National Competent Authority
Mutual Recognition Procedure (MRP)
An EU Procedure Type in which the competent authority of the lead EU country reviews and approves the application. Other EU member states agree to “recognize” and approve the application…
Module 2
CTD Module of the quality/non clinical/clinical summaries documents.
Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that…
Medical Dictionary for Regulatory Activities (MedDRA)
A clinically validated international medical terminology dictionary used by regulatory authorities in the pharmaceutical industry during the regulatory process, e.g., pre-marketing, post-marketing, data entry.
Marketing Authorisation Holder (MAH)
The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States. Source: Marketing Authorisation Holder
Marketing Authorisation Application (MAA)
An application made to a European regulatory authority for approval to market a medicine within the European Union. Also use din other markets and as a general term. Source: EMA…
Lifecycle Operations
The operation attribute gives the status of the new file (where applicable) in relation to what has been submitted previously, and it has the following possible values: "new" - the…