Definitions

Audit: A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, Sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). (GCP, 1.6)
Case Report Form (CRF): 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. (GCP, 1.11)
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. (GCP, 1.20)
Clinical Trial: An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (FDR-Div. 5)
Date of Commencement of a Clinical Trial: The date when the clinical trial site will be ready to enrol patients in the clinical trial.(3)
Direct Access: Permission to examine, analyse, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, Sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and Sponsor's proprietary information. (GCP, 1.21)
Documentation: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. (GCP, 1.22)
Drug: Means a drug for human use that is to be tested in a clinical trial. (source: FDR-Div. 5)
Essential Documents: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (GCP, 1.23, see also section 8 "Essential Documents for the Conduct of a Clinical Trial").
Good Clinical Practices: Generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010 of Division 5 of the Food and Drug Regulations. (FDR-Div. 5)
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) to be related to the clinical trial and that may be located at the site of the trial, at the Sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). (GCP, 1.29)
Original Medical Record: See Source Documents (GCP, 1.43)
Qualified Investigator: The person responsible to the Sponsor for the conduct of the clinical trial at the clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is
in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and
in any other case a physician and a member in good standing of a professional medical association. (FDR-Div. 5)
Research Ethics Board: A body that is not affiliated with the Sponsor, and
the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and
that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration Act, that is composed of both men and women and that includes at least:
two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline,
one member knowledgeable in ethics,
one member knowledgeable in Canadian laws relevant to the biomedical research to be approved,
one member whose primary experience and expertise are in a non-scientific discipline, and
one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the Sponsor or the site where the clinical trial is to be conducted. (FDR-Div. 5)
Senior Medical or Scientific Officer: A scientific or medical officer residing in Canada, representing the Sponsor, who is responsible for providing an attestation with respect to the Clinical Trial Application / Amendment at the time of filing.(3)
Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). (GCP, 1.51)
Source Document: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). (GCP, 1.52)
Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. (GCP 1.53)
Trial Site: The location(s) where trial-related activities are actually conducted. (GCP, 1.59)