Uønsket medisinsk

hendelse

• In the pre-approval clinical experience with a new investigational product or its new usages (particularly as the therapeutic dose(s) may not be established): unfavourable and unintended responses, such as a sign (e.g., laboratory results), symptom or disease related to any dose of a medicinal product where a causal relationship between a medicinal product and an adverse event is a reasonable possibility. The level of certainty about the relatedness of the adverse drug reaction to an investigational product will vary. If the AR is suspected to be medicinal product-related with a high level of certainty, it should be included in the reference safety information (RSI) and/or the Investigator’s Brochure (IB).

• For marketed medicinal products: a response to a drug that is noxious and unintended and that occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function. (See ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.) 

ICH GCP R3 

A document or set of documents describing the details of any arrangements on delegation or transfer, distribution and/or sharing of activities and, if appropriate, on financial matters between two or more parties. This could be in the form of a contract. The protocol may serve as the basis of an agreement.

ICH GCP R3 

A blank CRF with markings, or annotations, that coordinate each datapoint in the form with its
corresponding dataset name. An annotated CRF communicates where the data collected for each question is stored in the database

Oracle ® Creating a study

Is part of the mandatory safety reporting. Regulation (EU) No 536/2014, art 43. The annual report should be sent on a DSUR format (not marketed products) or on a simplified Annual Safety Report (marketed products using the Summary of ProductChracteristics (SmPC) as Reference Safety Information). ICH guideline E2F on development safety update report

Clinical Trials Coordination Group (CTCG)

Affirmative agreement of a minor to participate in clinical trial. The absence of expression of agreement or disagreement should not be interpreted as assent.

ICH GCP R3

A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract research organisation (CRO)) or institution to determine whether the evaluated trial-related activities were conducted and the data were recorded, analysed and accurately reported according to the protocol, applicable standard operating procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

ICH GCP R3

Metadata records that allow the appropriate evaluation of the course of events by capturing details on actions (manual or automated) performed relating to information and data collection and, where applicable, to activities in computerised systems. The audit trail should show activities, initial entry and changes to data fields or records, by whom, when and, where applicable, why. In computerised systems, the audit trail should be secure, computer-generated and time stamped. 

ICH GCP R3

A data acquisition tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial participant (see Data Acquisition Tool). 

ICH GCP R3

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information as the original, including relevant metadata, where applicable.

ICH GCP R3

Klinisk (legemiddel)

utprøving

“Clinical trial” means a clinical study (see definition) which fulfils any of the following conditions:

1. The assignment of the subject/participant to a particular
   therapeutic strategy is decided in advance and
   does not fall within normal clinical practice of the Member State concerned;
2. the decision to prescribe the investigational
   medicinal products is taken together with the
   decision to include the subject/participant in the clinical
   study; or
3. diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects/participants.

A clinical trial shall be subject to scientific and ethical
review and shall be authorised in accordance with Regulation (EU) No 536/2014, Article 2.

Komonitorering

Monitoring together with someone else as part of

training.

Sammenligningspreparat

An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical trial.

ICH GCP R3

Validering av elektroniske systemer

A process of establishing and documenting that the specified requirements of a computerised system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect trial participant protection and the reliability of trial results.

ICH GCP R3

Etterlevelse

Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements.

ICH GCP R3

Konfidentialitet

Prevention of disclosure to other than authorised individuals of a sponsor’s proprietary information or of a participant’s identity or their confidential information.

ICH GCP R3

CRO

See Service Provider. 

Koordinerende utprøver

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.
ICH GCP R3

For clinical trials, a coordinating investigator (CI) has the responsibility for the coordination of all investigators at different centers. In addition to ensuring that the investigators fulfill their responsibilities and tasks, the CI is responsible for performing sponsor tasks for the other countries in multinational studies as well as its own.

Roles and Responsibilities in Clinical Trials, NorCRIN

A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial according to the protocol and to report the data to the sponsor. The data originator may be a human (e.g., the participant or trial staff), a machine (e.g., wearables and sensors) or a computer system from which the electronic transfer of data from one system to another has been undertaken (e.g., extraction of data from an electronic health record or laboratory system). Examples of DATs include but are not limited to CRFs, interactive response technologies (IRTs), clinical outcome assessments (COAs), including patient-reported outcomes (PROs) and wearable devices, irrespective of the media used.

ICH GCP R3

An application for entering data/information into a database.

Data integrity includes the degree to which data fulfil key criteria of being attributable, legible, contemporaneous, original, accurate, complete, secure and reliable such that data are fit for purpose.

All documentation that is part of data management, see Data Management - SOP 1.12.b

Detailed Commission guidelines on good maufacturing practice for investigational medicinal products.

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (europa.eu)

Auxiliary Medicinal Products in Clinical Trials

A common standard for periodic (annual) reporting on drugs under development (including marketed drugs that are under further study).
ICH guideline E2F on development safety update report

A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects
then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active).
ICH E9 Note for Guidance on Statistical Principles for Clinical Trials

A double-blind trial is one in which neither the participant nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the participants are aware of the treatment received. This includes anyone determining participant eligibility, evaluating endpoints, or assessing compliance with the protocol. This level of blinding is maintained throughout the conduct of the trial, and only when the data are cleaned to an acceptable level of quality will appropriate personnel be unblinded.
ICH E9 Note for Guidance on Statistical Principles for Clinical Trials

“Early termination of a clinical trial” means the premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with.
Regulation (EU) No 536/2014, Article 2.

Electronic solution to collect participant data in a clinical trial.

See Data acquisition tools

Sluttidspunkt for en

klinisk utprøving

“End of a clinical trial’ means the last visit of the last participant, or at a later point in time as defined in the protocol.
Regulation (EU) 536/2014, Article 2.

Essensielle fortegnelser

Essential records are the documents and data (and relevant metadata), in any format, associated with a clinical trial that facilitate the ongoing management of the trial and collectively allow ICH GCP R3 Guideline 74 the evaluation of the methods used, the factors affecting a trial and the actions taken during the trial conduct to determine the reliability of the trial results produced and the verification that the trial was conducted in accordance with GCP and applicable regulatory requirements (see Appendix C in ICH GCP R3.

ICH GCP R3 

EU-søknadsskjema

Application form to be completed and submitted for a clinical trial to regulatory authorities (e.g. DMP) and ethics committees (e.g. REK). Valid for all EU/EEC countries.
Regulation (EU) No 536/2014, Article 16, Annex I and II.

EU-utprøvingsnummer

A unique identifying number for a specific clinical trial in the EU database.
Regulation (EU) No 536/2014, Article 81.

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.

ICH GCP R3 

A person who is independent of the trial who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the participant or the participant’s legally acceptable representative cannot read, and who reads the informed consent form and any other documented information supplied or read to the participant and/or their legally acceptable representative.

ICH GCP R3

A subject who is, for reasons other than the age of legal competence to give informed consent, incapable of giving informed consent according to the law of the Member State concerned;

Regulation (EU) 536/2014, Article 10 and 31.

See also Vulnerable participant.

An independent data monitoring committee (e.g., data safety monitoring board) that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety and relevant efficacy data, and to recommend to the sponsor whether to continue, modify or stop a trial.

ICH GCP R3

Informert samtykke/

samtykkeskjema

“Legally designated representative” means a
natural or legal person, authority or body which, according to the law of the Member State concerned, is empowered to give informed consent on behalf of a subject who is an incapacitated subject or a minor.

Regulation (EU) No 536/2014, Article 2.
I Norway, next of kin according to pasient- og brukerrettighetsloven § 1–3 letter b.

“Low-intervention clinical trial” means a clinical trial which fulfils all of the following conditions:

1. the investigational medicinal products,
   excluding placebos, are authorised;
2. according to the protocol of the clinical trial,
   1.  the investigational medicinal products are used in accordance with the terms of the marketing authorisation; or
   2. the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and
3. the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in
   any Member State concerned.

Tilvirkning av legemiddel

Sponsor representative assessing the safety aspects for a clinical trial.

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 allow the appropriate evaluation of the trial conduct.

ICH GCP R3

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). 

ICH GCP R3

A document that describes the strategy, methods, responsibilities and requirements for monitoring the trial. 

ICH GCP R3

A documented report following site and/or centralised monitoring activities. 

ICH GCP R3

A clinical trial conducted according to a single protocol but at more than one investigator site.

ICH GCP R3

An individual who participates in a clinical trial who is expected to receive the investigational product(s) or as a control. Trial participant and participant are used interchangeably. 

ICH GCP R3

Regulation (EU) No 536/2014 refers to participants as subjects. 

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.

ICH GCP R3

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). 

ICH GCP R3

The operational techniques and activities undertaken to verify that the requirements for quality of the trial-related activities have been fulfilled.

ICH GCP R3

The process of deliberately including an element of chance when assigning participants to groups that receive different treatments in order to reduce bias.

ICH GCP R3

Comparing two sets of records to check that data are in agreement.

Contains a cumulative list of ARs that are expected for the investigational product being administered to participants in a clinical trial. The RSI is included in the Investigator’s Brochure or alternative documents according to applicable regulatory requirements (e.g. SmPC). Refer to ICH E2F Development Safety Update Report for more information about RSI. 

ICH GCP R3

Legemiddelmyndigheter

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.

ICH GCP R3

In Norway, it is Direktoratet for medisinske produkter (DMP)

Rekvirering

(resept/rekvisisjon)

“Serious adverse event” means any untoward medical occurrence that at any dose:

• Requires inpatient hospitalisation or prolongation of existing hospitalization
• Results in persistent or significant disability or incapacity
• Results in a congenital anomaly or birth defect
• Is life-threatening
• Results in death

A person or organisation (commercial, academic or other) providing a service used by either the sponsor or the investigator to fulfil trial-related activities.

ICH GCP R3

The service provider can be internal or external to the organisation/institution.

A unique mark, symbol or entry executed, adopted or authorised by an individual, in accordance with applicable regulatory requirements and/or practice to show expression of will and allow authentication of the signatory (i.e., establish a high degree of certainty that a record was signed by the claimed signatory). A signature may be physical or electronic.

ICH GCP R3

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 (e.g., electronic patient-reported outcomes (ePROs)); healthcare professionals’ records from pharmacies, laboratories and other facilities involved in the clinical trial; and data from automated instruments, such as wearables and sensors. 

ICH GCP R3

Detailed, documented instructions to achieve uniformity of the performance of a specific activity.

ICH GCP R3

Describes responsibility, delegation and who does what, when and how.

Starttidspunkt for en

klinisk utprøving

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 

ICH GCP R3 

Different presentations of data in trial reports and/or publications.