A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T. U. V. W. X. Y. Z.
A
Adverse Event (AE): Any unfavourable medical occurrence in a trial participant. The adverse event does not necessarily have a causal relationship with the treatment. Adverse Drug Reaction (ADR):
Serious Adverse Event (SAE): Any unfavourable medical occurrence that is considered serious at any dose if it:
Suspected Unexpected Serious Adverse Reaction (SUSAR): an adverse reaction that meets three criteria: suspected, unexpected and serious.
|
|
|
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 |
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. |
|
Affirmative agreement of a minor to participate in clinical trial. The absence of expression of agreement or disagreement should not be interpreted as assent. |
|
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). |
|
A declaration of confirmation by the auditor that an audit has taken place. |
|
Metadata records that allow reconstruction 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 timestamped. |
B.
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the participant(s) being unaware, and double blinding usually refers to the participant(s), investigator(s) or other trial staff, as appropriate, being unaware of the treatment assignment(s). |
C.
A tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial participant (see Data Acquisition Tool). |
|
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. |
|
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. |
|
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 (see ICH E3 Structure and Content of Clinical Study Reports). |
|
An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical trial. |
|
Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements. |
|
Prevention of disclosure to other than authorised individuals of a sponsor’s proprietary information or of a participant’s identity or their confidential information |
|
An investigator assigned the responsibility for the coordination of investigators at different investigator sites participating in a multicentre trial (if appropriate) |
|
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. |
|
D.
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 an electronic transfer of data from one system to another (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), patient-reported outcomes (PROs), clinical outcome assessments (COAs) and wearable devices, irrespective of the media used. |
|
A set of policies, standards, and processes that ensure health research data is managed responsibly, securely, and in compliance with ethical and legal requirements. In health research, data governance defines how data is collected, stored, accessed, shared, and reused, with clear roles and accountability. It protects participant privacy, ensures data quality and integrity, and supports responsible data sharing in line with informed consent and regulatory frameworks. |
|
Permission to examine, analyse and verify records that are important to the evaluation of a clinical trial and may be performed in person or remotely. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of participants’ identities and their data and sponsor’s proprietary information. |
E.
EDC (Electronic Data Capture): Electronic systems used to collect clinical data directly from study sources (e.g., electronic CRFs). IRT (Interactive Response Technology): Systems that manage randomization, treatment assignment, and study drug supply (also known as IVRS/IWRS). |
|
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 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. Essential Records for the Conduct of a Clinical Trial). |
F.
-
G.
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. |
H.
-
I.
J.
-
K.
-
L.
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. |
M.
N.
Biomedical studies not performed on human participants. |
O.
See Source Records. |
P.
Q.
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). |
|
The operational techniques and activities undertaken to verify that the requirements for quality of the trial-related activities have been fulfilled. |
|
Research that focuses on understanding people's experiences, opinions, or behaviours using non-numerical data, like interviews, observations, or written texts. |
R.
S.
T.
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. |
|
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. |
U.
-
V.
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 ICH E6(R3) Guideline 57 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. |
W.
-
X.
-
Y.
-
Z.
-