assets/GSKGlossary.md

GSK Glossary

Nr	Abbreviation	Full Term	Synonym	Definition	Context
1	+/- VE	Positive/Negative	N/A	N/A	-
2	Active Substance	N/A	Active Ingredient	Active pharmaceutical Ingredient (API)	Any component that provides pharmacological activity or other direct effects. Used in pharmacology and drug formulation. Example: "The active substance in this medication is ibuprofen."
3	ADR	Adverse Drug Reaction	N/A	For new investigational product or its new usage, unfavurable and unintended responses that can be caused by a relationship between a medicinal product and an adverse event. For any marketed medicinal product, the response to a drug that is noxious and unintended and occurs at doses normally used in humans.	N/A
4	AE	Adverse Event	N/A	Any untoward medical occurrence in a patient administered a pharmaceutical product. Used in clinical trials and pharmacovigilance to monitor drug safety. Example: "The patient reported an AE after taking the medication."	N/A
5	AESI	Adverse Events of Special Interest	N/A	Specific adverse events that are of particular concern for a drug or class of drugs. Monitored closely in clinical trials and post-marketing surveillance. Example: "AESIs for this vaccine include severe allergic reactions."	N/A
6	Agreement	N/A	N/A	Document or set of documents describing the details of any agreements on activities between two or more parties. This could be a form of contract. The protocol may serve as the basis of an agreement.	N/A
7	Applicant	N/A	N/A	The person or entity that submits an application for a regulatory activity. Involved in the regulatory submission process. Example: "The applicant must provide comprehensive data to the EMA."	N/A
8	Applicable Regulatory Requirement(s)	N/A	N/A	Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.	N/A
9	aPV	Additional Pharmacovigilance	N/A	Extra measures taken to monitor the safety of a drug. Used to enhance drug safety monitoring. Example: "aPV activities include additional safety studies."	N/A
10	EPAR	European Public Assessment Report	N/A	Set of published documents that describe the evaluation of a drug authorized. Used in regulatory affairs to provide detailed information on the evaluation of medicinal products by the EMA. Example: "The EPAR for this new drug highlights its efficacy and safety profile."	N/A
11	Assent	N/A	N/A	Affirmative agreement of a minor to participate in clinical trial. The absence of expression of agreement or disagreement should not be interpreted as assent.	N/A
12	ASCII	N/A	N/A	American Standard Code for Information Interchange. Used in data encoding and communication protocols. Example: Ensuring data integrity in electronic health records.	N/A
13	Audit	N/A	N/A	A systematic and independent examination of trial-related activities and records performed by sponsor, service provider or institution to ensure clinical trial activities were recorded, analysed and accurately reported as per protocol, application SOPs, GCP and applicable regulatory requirement(s).	N/A
14	Audit Certificate	N/A	N/A	A declaration of confirmation by the auditor that an audit has taken place.	N/A
15	Audit Report	N/A	N/A	A record describing the conduct and outcome of the audit.	N/A
16	Audit Trail	N/A	N/A	Metadata records that allow reconstruction of course of events by capturing details on actions performed related to information and data collection and activities in computerised system. The audit trail provides information on whom, when, where and why the initial entry, change to data fields or record happened.	N/A
17	BEST	Biologics Effectiveness and Safety	N/A	A program to evaluate the effectiveness and safety of biologic products. Used in the context of biologic drug development and monitoring. Example: "The BEST program provides valuable data on biologic therapies."	N/A
18	Biopharmaceuticals	Biologics	N/A	A pharmaceutical product derived from biological sources and especially the ones produced by biotechnology. Used in drug development and therapeutic treatments. Example: Monoclonal antibodies for cancer therapy.	N/A
19	Blinding	N/A	Masking	A procedure in which one or more parties to the trial are kept unaware of the treatment assignments(s). Single-blinding usually refers to participant(s), investigator(s) or other trial staff.	N/A
20	BP	Blood Pressure	N/A	The pressure of circulating blood on the walls of blood vessels. A critical parameter in clinical studies and patient monitoring. Example: "The drug's effect on BP was measured."	N/A
21	BRP	Expert Panels	N/A	Blue Ribbon Panels (BRPs) provide a forum for MedDRA experts from industry and regulatory authorities to discuss and make recommendations to the MedDRA Management Committee on challenging MedDRA issues on behalf of the user community. Used in regulatory discussions and decision-making. Example: Reviewing new drug safety data.	N/A
22	CAERS	Adverse Event Reporting System	CFSAN	US Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System. Used in monitoring and reporting adverse events. Example: Reporting side effects of dietary supplements.	N/A
23	Case	Clinical Studies	N/A	Individual instances of adverse events or other reportable conditions in pharmacovigilance and clinical trials. Used in epidemiology and clinical research. Example: "The number of COVID-19 cases in the study was recorded."	N/A
24	CRF	Case report form	N/A	A tool to record protocol-required information to be reported by investigator to sponsor on each trial participant.	N/A
25	Certified Copy	N/A	N/A	A copy of original record that has been verified to have the same information as the original, including relevant metadata.	N/A
26	CDC	Centers for Disease Control and Prevention	N/A	A national public health institute in the United States. Involved in disease prevention and control. Example: "The CDC provides guidelines for vaccine administration."	N/A
27	Change Request	Modification Request	N/A	A MedDRA Change Request (CR) allows a MedDRA subscriber to recommend changes, corrections or improvements to MedDRA and to Standardised MedDRA Queries (SMQs). Used in maintaining and updating medical terminology databases. Example: Adding new medical terms to MedDRA.	N/A
28	CHMP	Committee for Medicinal Products for Human Use	N/A	Committee responsible for preparing the EMA's opinions on questions concerning human medicines. Involved in the assessment and approval process of new medicines in the EU. Example: "The CHMP has recommended the approval of the new vaccine."	N/A
29	CIOMS	International Medical Organizations	N/A	Council for International Organizations of Medical Sciences. Used in global health policy and guidelines. Example: Developing ethical guidelines for clinical trials.	N/A
30	Clinical Trial	N/A	N/A	Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.	N/A
31	CSR	Clinical Study Report	Clinical Trial Report	A documented description of a trial of any investigational product conducted in human participants, in which the clinical and statistical description, presentations and analyses are fully integrated into a single report.	N/A
32	Comparator	N/A	N/A	An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical trial.	N/A
33	Compliance	N/A	N/A	Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements. Compliance in relation to trials.	N/A
34	Confidentiality	N/A	N/A	Prevention of disclosure to other than authorised individuals of a sponsor’s proprietary information or of a participant’s identity or their confidential information.	N/A
35	Coordinating Investigator	N/A	N/A	An investigator assigned the responsibility for the coordination of investigators at different investigator sites participating in a multicentre trial (if appropriate).	N/A
36	Computerised System Validation	N/A	N/A	A process of establishing and documenting that the specified requirements of a computerised system can be consistently fulfilled from design until decommissioning of system or transition to a new system.	N/A
37	Complex Change Request	Major Modification	N/A	Changes to MedDRA levels above PT (i.e., HLT, HLGT and SOC). Used in significant updates to medical terminology. Example: Reclassifying disease categories in MedDRA.
38	Control	Controlled Population	N/A	A group in a clinical trial that receives a placebo or standard treatment for comparison. Used to assess the efficacy of a new treatment. Example: "The control group received a placebo."	N/A
39	COSTART	Adverse Reaction Terms	N/A	Coding Symbols for a Thesaurus of Adverse Reaction Terms. Used in coding and reporting adverse drug reactions. Example: Standardizing adverse event terminology in clinical trials.	N/A
40	CRO	Clinical Research Organization	N/A	Contract Research Organisation. Used in outsourcing clinical trial management. Example: Conducting multi-center clinical trials.	N/A
41	CTCAE	Adverse Event Criteria	N/A	US Common Terminology Criteria for Adverse Events. Used in assessing and grading adverse events in clinical trials. Example: Reporting severity of chemotherapy side effects.	N/A
42	CTD	Common Technical Document	N/A	Common Technical Document. Used in regulatory submissions for drug approval. Example: Submitting clinical trial data to regulatory agencies.	N/A
43	DAT	Data Acquisition Tool	N/A	A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial according to protocol and to report data to sponsor. Data originator could be a human, machine or electronic transfer of data from system to another. Examples of DATs include but are not limited to CRFs, interactive response technologies (IRTs), patient-reported outcomes (PROs), clinical outcome assessments (COAs) and wearable devices, sensors, laboratory system, irrespective of the media used.	N/A
44	Direct Access	N/A	N/A	Permission to examine, analyse and verify records that are important to the evaluation of clinical trial that may be performed in person or remotely.	N/A
45	DIA	Drug Information Association	N/A	N/A	Used in professional development and networking in the pharmaceutical industry. Example: Attending DIA conferences for industry updates.
46	Dose	N/A	N/A	The amount of a drug administered to a patient. Critical in determining the efficacy and safety of a drug. Example: "The recommended dose is 50 mg daily."	N/A
47	EEA	European Economic Area	N/A	Used in regulatory and trade contexts within Europe. Example: Compliance with EEA pharmaceutical regulations.	N/A
48	EHR	Electronic Health Record(s)	Electronic Medical Record (EMR), Personal Health Record (PHR)	A systematized collection of patient and population information, electronically stored health in a digital format. These records can be shared across different health care settings and include data such as demographics, medical history, medications, lab results, and more. EHRs are used in healthcare settings to improve the quality and efficiency of patient care. They provide a comprehensive view of a patient's medical history, facilitate better coordination among healthcare providers, and support clinical decision-making. EHRs are also used for billing, reporting, and research purposes.	N/A
49	EFPIA	European Pharma Association	N/A	European Federation of Pharmaceutical Industries and Associations, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee. Used in representing pharmaceutical industry interests in Europe. Example: Advocacy for pharmaceutical innovation policies.	N/A
50	EMA	European Medicines Agency	N/A	Agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. Central to the approval and monitoring of medicines in Europe. Example: "The EMA has issued new guidelines for clinical trials."	N/A
51	EMA	European Medicines Agency	N/A	N/A	Used in drug regulation and approval within the EU. Example: EMA approval of new vaccines.
52	EMEA	European Medicines Agency	N/A	Europe, Middle East, and Africa. Refers to the geographical region covered by the EMA. Example: "The EMEA region has specific regulatory requirements."	N/A
53	Essential Records	N/A	N/A	Essential records are the documents and data in any format, associated with clinical trials that facilitate the ongoing management of the trial and collectively allow the evaluation of method used.	N/A
54	EU	European Union	N/A	N/A	Used in regulatory and policy contexts within Europe. Example: EU regulations on drug safety.
55	EudraVigilance/EVWEB	Drug Safety Database	N/A	Web-based system developed by EMA to collect and store ICSRs for all drugs with adverse events occurring in Europe. Used in pharmacovigilance and drug safety monitoring. Example: Reporting adverse drug reactions in Europe.	N/A
56	EVWEB	EudraVigilance Web	N/A	N/A	Used in accessing the EudraVigilance database. Example: Submitting adverse event reports online.
57	Expert Panel	Advisory Committee	N/A	The MedDRA Expert Panel was established by the MSSO to provide feedback to the MSSO on difficult change requests and other problematic maintenance issues. Used in providing expert advice on medical terminology. Example: Reviewing complex change requests in MedDRA.	N/A
58	FAERS	Adverse Event Reporting System	N/A	US FDA Adverse Event Reporting System; formerly known as "AERS". Used in monitoring and reporting adverse drug events. Example: Reporting side effects of new medications.	N/A
59	FDA, United States	Food and Drug Administration	N/A	US Food and Drug Administration, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee. Used in drug regulation and approval in the US. Example: FDA approval of new drugs.	N/A
60	GCP	Good Clinical Practice	N/A	A standard for the planning, initiating, performing, recording, oversight, evaluation, analysis and reporting of clinical trials that provides assurance that the data and reported results are reliable and that the rights, safety and well-being of trial participants are protected.	N/A
61	GVP	Pharmacovigilance Practices	N/A	Good Pharmacovigilance Practices. Used in ensuring drug safety and efficacy. Example: Implementing GVP guidelines in clinical trials.	N/A
62	HARTS	Adverse Reaction Terminology	N/A	Hoechst Adverse Reaction Terminology System. Used in coding and reporting adverse drug reactions. Example: Standardizing adverse event terminology in clinical trials.	N/A
63	Health Canada, Canada	Canadian Health Department	N/A	Canadian Federal department for health, is one of the ICH Observers and also a member of the ICH MedDRA Management Committee. Used in drug regulation and approval in Canada. Example: Health Canada approval of new medications.	N/A
64	HLGT	High Level Group Term	N/A	High Level Group Term level of MedDRA. Used in medical terminology classification. Example: Grouping related medical terms in MedDRA.	N/A
65	HLT	High Level Term	N/A	High Level Term level of MedDRA. Used in medical terminology classification. Example: Grouping related medical terms in MedDRA.	N/A
66	IB	Investigator's Brochure	N/A	A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human participants.	N/A
67	ICD	Disease Classification	N/A	International Classification of Diseases. Used in coding and reporting diseases. Example: ICD codes for billing and insurance purposes.	N/A
68	ICD-CM	Clinical Modification	N/A	International Classification of Diseases - (Clinical Modification). Used in coding and reporting diseases in clinical settings. Example: ICD-CM codes for hospital records.	N/A
69	ICH	Harmonisation Council	N/A	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs. Used in developing global pharmaceutical guidelines. Example: ICH guidelines for clinical trial conduct.	N/A
70	ICH Assembly	Governing Body	N/A	Is the body that governs the ICH, determines the policies and procedures for ICH, selects topics for harmonisation and monitors the progress of harmonisation initiatives. Each of the six Parties has two seats on the ICH Assembly. Each of the Observers nominates non-voting participants to attend the ICH Assembly Meetings, IFPMA also participates as a non-voting observer. Used in overseeing ICH activities and initiatives. Example: Setting priorities for pharmaceutical harmonisation.	N/A
71	ICH Secretariat	Administrative Office	N/A	Secretariat located in Geneva, Switzerland responsible for day-to-day management of ICH Assembly, Working Groups and MedDRA Management Committee activities as well as Global Cooperation with non ICH countries activities. Used in managing ICH operations and communications. Example: Coordinating ICH meetings and documentation.	N/A
72	ICSR	Safety Report	N/A	Individual Case Safety Report. Used in reporting individual adverse drug reactions. Example: Submitting ICSRs to regulatory authorities.	N/A
73	IDMC	Independent Data Monitoring Committee	N/A	Established by sponsor to assess at intervals the progress of clinical trial, the safety data and the critical efficacy endpoints and recommend the sponsor whether to continue modify or stop trial.	N/A
74	IFPMA	International Federation of Pharma Manufacturers Association	N/A	International Federation of Pharmaceutical Manufacturers and Associations. Used in representing pharmaceutical manufacturers globally. Example: Advocacy for global pharmaceutical policies.	N/A
75	Impartial Witness	N/A	N/A	Person who is independent of the trial and attends the informed consent process to read the informed consent form or any other documented information supplied to participants and their legal acceptable representative.	N/A
76	IMDRF	International Medical Device Regulators Forum	N/A	International Medical Device Regulators Forum. Used in harmonising medical device regulations. Example: Developing global standards for medical devices.	N/A
77	IMI	Medicines Initiative	N/A	Innovative Medicines Initiative. Used in promoting pharmaceutical innovation and research. Example: Funding collaborative research projects.	N/A
78	Informed Consent	N/A	N/A	A process by which a participant or their legally accepted representative voluntarily confirms their willingness to participate in a trial after having been informed and been provided with the opportunity to discuss all aspects of the trial that are relevant to the participant’s decision to participate. Varied approaches to the provision of information and the discussion about the trial can be used. This can include, for example, providing text in different formats, images and videos and using telephone or video conferencing with investigator site staff. Informed consent is documented by means of a written or electronic, signed and dated informed consent form. Obtaining consent remotely may be considered when appropriate.	N/A
79	Inspection	N/A	N/A	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) to be related to the clinical trial and that may be accessed at the investigator site, at the sponsor’s and/or service provider’s (including CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Some aspects of the inspection may be conducted remotely.	N/A
80	Institution	N/A	N/A	Any public or private entity or agency or medical or dental organisation in whose remit clinical trials are conducted.	N/A
81	IRB	Institutional Review Board/Independent Ethics Committee	IEC	An independent body (a review board or a committee, institutional, regional, national or supranational) constituted of medical professionals and non-medical members whose responsibility it is to ensure the protection of the rights, safety and well-being of human participants involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), the facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial participants. The legal status, composition, function, operations and regulatory requirements pertaining to IRBs/IECs may differ among countries but should allow the IRB/IEC to act in agreement with GCP as described in this guideline.	N/A
82	Inspection	N/A	N/A	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) to be related to the clinical trial and that may be accessed at the investigator site, at the sponsor’s and/or service provider’s (including CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Some aspects of the inspection may be conducted remotely.	N/A
83	Interim Clinical Trial/Study Report	N/A	N/A	A report of intermediate results and their evaluation based on analyses performed during the course of a trial.	N/A
84	Investigator Product	N/A	N/A	A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.	N/A
85	Investigator	N/A	N/A	A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility during the conduct of the trial. If a trial is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator. Where an investigator/institution is referenced in this guideline, it describes expectations that may be applicable to the investigator and/or the institution in some regions. Where required by the applicable regulatory requirements, the “investigator” should be read as “investigator and/or the institution.”	N/A
86	Investigator Site	N/A	N/A	The location(s) at or from where trial-related activities are conducted under the investigator’s/institution’s supervision.	N/A
87	ISO	International Standards Organization	N/A	ISO 9001:2008 is an internationally recognised quality management system standard developed by the International Organization for Standardization (ISO). Used in ensuring quality management in pharmaceutical manufacturing. Example: Implementing ISO standards in production processes.	N/A
88	J-ART	Japanese Adverse Reaction Terminology	N/A	N/A	Used in coding and reporting adverse drug reactions in Japan. Example: Standardizing adverse event terminology in Japanese clinical trials.
89	JMB	Japanese Management Board	N/A	Used in overseeing MedDRA activities in Japan. Example: Managing MedDRA updates and translations.	N/A
90	JMO	Japanese Maintenance Organization	N/A	Japanese Maintenance Organization, is a partner of the MSSO and is responsible for maintaining and distributing MedDRA in Japan. Used in maintaining MedDRA in Japan. Example: Distributing MedDRA updates to Japanese users.	N/A
91	JPMA	Japan Pharma Association	N/A	Japan Pharmaceutical Manufacturers Association, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee. Used in representing pharmaceutical manufacturers in Japan. Example: Advocacy for pharmaceutical policies in Japan.	N/A
92	Legally Acceptable Representative	N/A	N/A	An individual or juridical or other body authorised under applicable law to consent, on behalf of a prospective participant, to the participant’s participation in the clinical trial.	N/A
93	LLT	Lowest Level Term	N/A	Lowest Level Term level of MedDRA. Used in medical terminology classification. Example: Detailed coding of medical terms in MedDRA.	N/A
94	MAH	Marketing Authorization Holder	N/A	The company or entity that holds the authorization to market a drug. Responsible for the drug's compliance with regulatory requirements. Example: "The MAH must report any safety concerns to the EMA."	N/A
95	MAA	Marketing Authorization Application	New Drug Application (NDA) (US)	An application submitted by pharmaceutical companies to regulatory authorities seeking approval to market and distribute a new pharmaceutical product or a variation of an existing product. The application includes detailed scientific, technical, and regulatory information to ensure the product is safe, effective, and of high quality. MAAs are used in the pharmaceutical industry to obtain permission to bring new medicinal products to market. They are submitted to regulatory bodies such as the European Medicines Agency (EMA) or the UK Medicines and Healthcare products Regulatory Agency (MHRA). The process involves rigorous review to ensure compliance with safety, efficacy, and quality standards.	N/A
96	MedDRA	Medical Dictionary	N/A	Medical Dictionary for Regulatory Activities; developed under the auspices of ICH and maintained by MSSO, and providing an international medical dictionary applicable to all phases of biopharmaceutical and medical product development. Used in coding and reporting medical information. Example: Standardizing medical terminology in regulatory submissions.	N/A
97	MedDRA Code	Term Code	N/A	In contrast to the typical use of the word "code" in the regulatory milieu, within MedDRA, the code refers to the eight-digit number assigned to each term and is not to be confused with the text string of the term itself. Each term in MedDRA has a unique non-expressive 8-digit code. Used in identifying medical terms in MedDRA. Example: Using MedDRA codes for accurate data entry in clinical trials.	N/A
98	MedDRA Management Committee	MedDRA MC	N/A	Is appointed by the ICH Assembly to oversee the activities of the "Maintenance and Support Services Organisation" (MSSO) for MedDRA, and ensure that the MSSO is meeting the various needs of MedDRA users. The Management Committee is composed of one representative from each of the six ICH Parties and one representative from MHRA and Health Canada. The ICH MedDRA Secretariat supports the MedDRA Management Committee and acts as a non-voting observer on the committee. Used in overseeing MedDRA activities and ensuring its proper maintenance. Example: Reviewing updates and changes to MedDRA terminology.	N/A
99	MedDRA/J	Japanese MedDRA	N/A	Japanese translation of MedDRA. Used in coding and reporting medical information in Japan. Example: Using MedDRA/J for regulatory submissions in Japan.	N/A
100	MHLW, Japan	Japan Ministry of Health	N/A	Japan Ministry of Health, Labour and Welfare, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee. Used in drug regulation and public health in Japan. Example: MHLW approval of new pharmaceuticals.	N/A
101	MHRA, UK	UK Medicines Agency	N/A	UK Medicines and Healthcare Products Regulatory Agency, is a member of the ICH MedDRA Management Committee. Used in drug regulation and safety monitoring in the UK. Example: MHRA's role in approving new medications.	N/A
102	MSSO	MedDRA Maintenance Organization	N/A	Maintenance and Support Services Organization, the repository, maintainer, and distributor of MedDRA. Used in maintaining and distributing MedDRA. Example: MSSO's role in updating MedDRA terms.	N/A
103	Multiaxiality	Multi-Classification	N/A	Terms in MedDRA may belong to more than one SOC; this property, called multiaxiality, allows for flexibility in the output and analysis of MedDRA coded data. Used in flexible data analysis and reporting. Example: Analyzing adverse event data across multiple SOCs.	N/A
104	Metadata	N/A	N/A	The contextual information required to understand a given data element. Metadata is structured information that describes, explains or otherwise makes it easier to retrieve, use or manage data. For the purpose of this guideline, relevant metadata are those needed to reconstruct the trial conduct.	N/A
105	Monitoring	N/A	N/A	The act of overseeing the progress of a clinical trial and of ensuring that the clinical trial is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirement(s).	N/A
106	Monitoring Plan	N/A	N/A	A document that describes the strategy, methods, responsibilities and requirements for monitoring the trial.	N/A
107	Monitoring Report	N/A	N/A	A documented report following site and/or centralised monitoring activities.	N/A
108	Multicentre Trial	N/A	N/A	A clinical trial conducted according to a single protocol but at more than one investigator site.	N/A
109	NEC	Not Elsewhere Classified	N/A	Not elsewhere classified is a standard abbreviation used to denote groupings of miscellaneous terms that do not readily fit into other hierarchical classifications within a particular SOC. The NEC designation is used only with HLTs and HLGTs for grouping purposes. Used in grouping miscellaneous medical terms. Example: Classifying rare adverse events under NEC.	N/A
110	Nonclinical Study	N/A	N/A	Biomedical studies not performed on human participants.	N/A
111	NOS	Not Otherwise Specified	N/A	Not otherwise specified terms are only found on the LLT level and are meant to represent concepts for which no further specific information is available (e.g., during coding of adverse events). Used in coding non-specific medical terms. Example: Coding an adverse event as NOS when details are lacking.	N/A
112	Participants	Subjects	N/A	Individuals who take part in a clinical trial. Used in clinical research to refer to study volunteers. Example: "The trial has 100 participants."	N/A
113	PDF	Portable Document Format	N/A	N/A	Used in sharing and storing documents. Example: Submitting regulatory documents in PDF format.
114	Pharmacogenetic	Genetic Pharmacology	N/A	The study of the interrelation of hereditary constitution and response to drugs. Used in personalized medicine and drug development. Example: Studying genetic factors affecting drug metabolism.	N/A
115	Pharmacovigilance	Drug Safety Monitoring	N/A	The pharmacological science relating to detection, assessment, understanding and prevention of adverse effects, particularly the long and short term side effects of medicines. Used in monitoring and ensuring drug safety. Example: Conducting pharmacovigilance studies to detect adverse drug reactions.	N/A
116	Phase	N/A	N/A	A stage in the clinical trial process. Used to describe the different stages of clinical trials (Phase I, II, III, IV). Example: "The drug is currently in Phase II trials."	N/A
117	PhRMA	Pharma Association	N/A	Pharmaceutical Research and Manufacturers of America, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee. Used in representing pharmaceutical manufacturers in the US. Example: Advocacy for pharmaceutical research and development.	N/A
118	PIP	Paediatric Investigation Plan	N/A	A development plan aimed at ensuring that the necessary data are obtained through studies in children to support the authorization of a medicine for children. Used in the context of drug development and regulatory submissions. Example: "The PIP must be submitted to the EMA for approval before starting pediatric trials."	N/A
119	PMDA, Japan	Japan Drug Agency	N/A	Japan Pharmaceuticals and Medical Devices Agency. Used in drug and medical device regulation in Japan. Example: PMDA's role in approving new medical devices.	N/A
120	Population	-	N/A	The group of individuals participating in a clinical study. Used in clinical research to define the study sample. Example: "The study population includes adults aged 18-65."	N/A
121	PRAC	Pharmacovigilance Risk Assessment Committee	N/A	Committee responsible for assessing and monitoring the safety of human medicines. Focuses on the safety of medicines and risk management. Example: "The PRAC is reviewing the safety data for this medication."	N/A
122	Protocol	N/A	N/A	A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline, the term protocol refers to protocol and protocol amendments.	N/A
123	Protocol Amendment	N/A	N/A	A documented description of a change(s) to a protocol.	N/A
124	PT	Preferred Term	N/A	N/A	Used in coding and reporting medical terms in MedDRA. Example: Using PTs for standardized adverse event reporting.
125	PTC	Points to Consider	N/A	MedDRA Points to Consider documents provide best practice approaches for the use of MedDRA. Used in guiding the use of MedDRA. Example: Following PTC guidelines for accurate coding.	N/A
126	QA	Quality Assurance	N/A	All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirement(s).	N/A
127	QC	Quality Control	N/A	The operational techniques and activities undertaken to verify that the requirements for quality of the trial-related activities have been fulfilled.	N/A
128	QMS	Quality Management System	N/A	N/A	Used in ensuring quality in pharmaceutical manufacturing and processes. Example: Implementing a QMS to comply with regulatory standards.
129	Randomisation	N/A	N/A	The process of deliberately including an element of chance when assigning participants to groups that receive different treatments in order to reduce bias.	N/A
130	Rapporteur	Lead Representative	N/A	A representative of one of the six ICH parties designated by the Steering Committee when a new topic is formally adopted. The Rapporteur is responsible for leading a working group (EWG/IWG) and ensuring that the group keeps an up-to-date action plan and timetable, with clear deliverables and deadlines. Used in leading ICH working groups. Example: A Rapporteur coordinating the development of new guidelines.	N/A
131	Regulatory intelligence	N/A	N/A	New or updated regulations, standards or guidances, which could impact the acquisition or maintenance of regulatory licenses for a company.	N/A
132	Regulatory Authorities	N/A	N/A	Bodies having the power to regulate, including those that review submitted protocols and clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.	N/A
133	RMP	Risk Management Plan	N/A	A detailed description of the risk management system for a medicinal product. Used to ensure that the benefits of a drug outweigh its risks. Example: "The RMP outlines the strategies to monitor and mitigate risks."	N/A
134	RNA	Ribonucleic Acid	N/A	A molecule essential for various biological roles, including coding, decoding, regulation, and expression of genes. Used in the context of genetic research and vaccine development. Example: "mRNA vaccines use RNA to instruct cells to produce a protein that triggers an immune response."	N/A
135	RSI	Reference Safety Information	N/A	Contains a cumulative list of ADRs that are expected for the investigational product being administered to participants in a clinical trial. The RSI is included in the Investigator’s Brochure.	N/A
136	RWE	Real World Evidence	N/A	Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of Real World Data. It is the outcome of analyzing RWD to generate meaningful insights that can inform regulatory decisions. Patient-based non-interventional pre- or postauthorizsation studies performed to support the marketing authorization application (primary and/or secondary use of data) or Product-related literature review.	N/A
137	RWD	Real World Data	N/A	Data relating to patient health status and the delivery of healthcare routinely collected from a variety of sources. Different sources of RWD include: Electronic Health Records (EHRs), Claims and Billing Data, Product and Disease Registries, Patient-Generated Data, Pharmacy Data, Social Media and Online Health Communities, Clinical Practice Data, Public Health Databases.	N/A
138	SAE	Serious Adverse Event	Serious Adverse Reaction (SAR)	An unfavourable medical occurrence that is considered serious at any dose, if that results in death, is life-threatening, requires hospitalization, causes significant disability. Critical in assessing the safety profile of a drug. Example: "The clinical trial was paused due to an SAE."	N/A
139	Service Provider	N/A	N/A	A person or organisation (commercial, academic or other) providing a service used during the conduct of a clinical trial to either the sponsor or the investigator to fulfil one or more of their trial-related activities.	N/A
140	Simple Change	Minor Modification	N/A	Changes to the PT and LLT levels of MedDRA. Used in making minor updates to MedDRA terminology. Example: Adding a new PT to MedDRA.	N/A
141	Signature	N/A	N/A	A unique mark, symbol or entry in line with applicable regulatory requirements and/or practice to show expression of will and allow authentication of the signatory.	N/A
142	SMQ	Standardised Query	N/A	Standardised MedDRA Query is a grouping of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest. Used in querying MedDRA for specific medical conditions. Example: Using an SMQ to identify cases of liver toxicity.	N/A
143	SNOMED CT	Clinical Terminology	N/A	Systematized Nomenclature of Medicine -- Clinical Terms. Used in coding and reporting clinical information. Example: Using SNOMED CT for electronic health records.	N/A
144	SOC	System Organ Class	N/A	System Organ Class level of MedDRA. Used in classifying medical terms in MedDRA. Example: Grouping related terms under a single SOC.	N/A
145	SOP	Standard Operating Procedures	N/A	Detailed, documented instructions to achieve uniformity of the performance of a specific activity.	N/A
146	Source Records	N/A	N/A	Original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of the media used. This may include trial participants’ medical/health records/notes/charts; data provided/entered by trial participants healthcare providers’ records from pharmacies, laboratories and other facilities involved in the clinical trial; and data from automated instruments, such as wearables and sensors.	N/A
147	Sponsor	N/A	N/A	An individual, company, institution, or organisation that takes responsibility for the initiation, management and arrangement of the financing of a clinical trial. A clinical trial may have one or several sponsors where permitted under regulatory requirements. All sponsors have the responsibilities of a sponsor set out in this guideline. In accordance with regulatory requirements, sponsors may decide in a documented agreement setting out their respective responsibilities. Where the agreement does not specify to which sponsor a given responsibility is attributed, that responsibility lies with all sponsors.	N/A
148	Sponsor-Investigator	N/A	N/A	An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to or used by a participant. The term does not include any person other than an individual (e.g., the term does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.	N/A
149	Studies	Research	N/A	Systematic investigations to establish facts or principles. Used in the context of scientific research. Example: "The studies show promising results."	N/A
150	SUSAR	Suspected Unexpected Serious Adverse Reaction	N/A	An adverse reaction that meet following criteria: Suspected - a reasonable possibility that the drug caused the adverse reaction. Unexpected - adverse reaction whether the AE's nature or severity is not consistent with the application product information. Serious Adverse Event.	N/A
151	Sub-investigator	N/A	N/A	Any individual member of the clinical trial team designated and supervised by the investigator to perform critical trial-related procedures and/or to make important trial-related decisions e.g., associates, residents, research fellows.	N/A
152	Table	N/A	N/A	N/A	N/A
153	Trial	Clinical Trial	N/A	A research study to evaluate the safety and efficacy of a medical intervention. Essential in the drug development process. Example: "The clinical trial is in Phase III."	N/A
154	Trial Participant	N/A	N/A	An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.	N/A
155	Trial Participant Identification Code	N/A	N/A	A unique identifier assigned to each trial participant to protect the participant’s identity and used in lieu of the participant’s name when the investigator reports adverse events and/or other trial-related data.	N/A
156	VAERS	Vaccine Adverse Event Reporting System	N/A	US Vaccine Adverse Event Reporting System. Used in monitoring and reporting vaccine-related adverse events. Example: Submitting reports to VAERS for vaccine safety monitoring.	N/A
157	Vulnerable Participants	N/A	N/A	Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are: members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students; subordinate hospital and laboratory personnel; employees of the pharmaceutical industry; members of the armed forces and persons kept in detention. Other vulnerable participants may include persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors and those incapable of giving consent.	N/A
158	WEB-RADR	Adverse Drug Reaction Reporting	N/A	Web Recognising Adverse Drug Reactions. Used in reporting adverse drug reactions online. Example: Using WEB-RADR for mobile reporting of adverse events.	N/A
159	WHO	World Health Organization	N/A	World Health Organization and one of the ICH Observers. Used in global health policy and guidelines. Example: WHO's role in setting international health standards.	N/A