(d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application. Good Clinical Practice (GCP) GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. Although the retention period of records starts on the date the record is created, sponsors may choose to "start the clock" for retention of all study records upon completion or termination of the trial to simplify the process. The sponsor did not notify Health Canada within 15 days of implementing an immediate amendment where the clinical trial or the use of the study drug endangered the health of a clinical trial participant or other person. To maintain the integrity of all records, their location should assure protection from possible damage (e.g. These definitions explain how terms are used in this document. the situation giving rise to the intended suspension has been corrected, and will be given an opportunity to be heard as required under the Regulations. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval (ICH E6, 8.1). These requirements include, but are not limited to the following: The process for obtaining informed consent using an electronic form should also be well detailed in an SOP, including how the form will be explained and discussed with the clinical trial subject (will the subject have the option to sign a paper copy, bring a copy home or have access to an electronic signed copy, etc.). Electronic records may be generated during clinical trials. (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if. (h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices. The sponsor did not implement systems and procedures to ensure that staff was adequately trained on. For enquiries,contact us. measures are in place to verify that the transfer is accurate and done by appropriately trained individuals (e.g. hospital-based systems) not under the responsibility of the sponsor, an alternate method to validation could be considered (e.g. Average Learning Time: ~5 - 7 hours. (i) the requirements respecting information and records set out in section C.05.012 are met; and. - Higher earning potential A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, as per the Regulations. The sponsor did not inform Health Canada within 15 days of becoming aware of serious unexpected adverse drug reactions in or outside Canada that were not fatal or life threatening. The procedures may be trial- or site-specific and be provided by the sponsor or the third party that was delegated the responsibility. Potential participants in a clinical trial have the right to know the foreseeable risks or inconveniences and expected benefits that are part of the study they are thinking about joining [ICH E6, 4.8.10 (g) and (h)]. The ICF should be paginated to ensure that the complete document is presented to the subject. You will not receive a reply. Clinical Research Coordinator (CRC) Range: C$44k - C$69k. In May 1997, Health Canada adopted the International Conference on Harmonization (ICH) Guidance E6(R1): Good Clinical Practice Consolidated Guideline (ICH E6). The impact of such a change should be evaluated and documented, and partial validation of some components of the electronic system may be required. primary container) such that its identity can be determined, and, if necessary, which unit was dispensed to each subject. (i) 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. Neither the investigator, nor the trial staff, should, in any way, coerce or influence a subject to participate or to continue to participate in a trial (ICH E6, 4.8.3). In addition, the process to describe the destruction of the original paper records should be documented in appropriate procedures. lot number and expiration date) through a validated computerized system. For more information with regards to the transfer of essential records to a secondary medium, refer to the CGSB standard Electronic Records as Documentary Evidence, CAN/CGSB-72.34-2017. The label of the drug did not contain the required information. Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor (ICH E6, 5.2.3). during study start-up meetings), site-initiated training (e.g. further sub delegation to individual staff does not need to be documented in the log, provided that evidence of qualification of those individuals is available. In ICH E6, an IRB or an IEC is defined as: "An independent body (a review board or 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 subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.". (2) For the purposes of subsection (1), amendments are. UHN is one of the Member Companies of the TransCelerate Mutual Recognition Program for ICH E6 Good Clinical Practice Training. Health Canada does not require a specific document-type and/or format but there should be documentation that adequately covers all critical study-related activities. Regardless of the risk-based approach, all equipment used in a study should be calibrated and maintained. ICFs submitted by sponsors to Health Canada are reviewed as part of their application for authorization to conduct a clinical trial. table of contents. Health Canada shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if Health Canada reasonably believes that any of the circumstances outlined in C.05.016 (1)(a) through (d) apply. 6. clinical trial protocol and protocol amendment(s) 7. investigator's brochure . Applications and Submissions - Drug Products, Guidance Documents Applications and submissions Drug products. This practice would allow the subject to consent and start the trial at the same time. Investigator's brochure: means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). Depending on the deficiencies noted in the conduct of the study, the sponsor may also be requested to provide an impact analysis on the safety of the subjects in the study and the integrity of the collected data at that site. Sponsors may also be required to maintain records under provincial law, institutional policies, and contractual agreements with QIs, REBs or others. With all these components combined together, achieving success towards becoming an ICH GPC certified professional has never been easier or more possible than ever before! All source documents should also be retained for the entire record retention period even if a subject has withdrawn from the clinical trial. Only specific and unique documents that belong solely to the sponsor, the REB, the QI or other entities, must be kept at the conclusion or termination of a trial. For enquiries,contact us. Sites that neither screen nor enrol any subjects in a given clinical trial and that have not been delegated the responsibility of record retention by the sponsor do not need to retain clinical trial records in accordance with Part C, Division 5. (h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application. For those who don't have time or a budget for more formalized ICH GCP certifications, free online training sessions are also available - these often provide enough information to get certification at the end of the course. In such circumstances, Health Canada would issue a "Notice of Intent to Suspend", along with the Final Inspection Exit Notice (inspection report). These may include, but are not limited to: The responsibilities of the sponsor, QI, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use (ICH E6, 5.5.3). This person must be listed as the QI on the Qualified Investigator Undertaking (QIU) Form. This pre-requisite course for the GLP, GMP, QA/QC, and GCP courses introduces the various types of report writing required in bio-economy workplaces across Canada. ICH E6 does not make reference to importation of clinical trial drugs. Reports of on-site and/or centralized monitoring should be provided to the sponsor (including appropriate management and staff responsible for trial and site oversight) in a timely manner for review and follow up. sub-investigators). Documentation of training should include the content of the training such as the learning objectives, who attended and when the training occurred. It is designed to ensure that the objectives of the study can be met. Adverse event (AE): means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. The site should have a system in place to identify, document, assess and report all the protocol deviations to the sponsor and REB in accordance with the sponsor's and REB's requirements. clinical trials involving pharmaceuticals, biologics, gene therapies, cell therapies, blood products, vaccines and radiopharmaceuticals for human use, clinical trials involving medical devices, clinical trials involving natural health products (, observational studies, which do not include drug intervention, encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity. However, the use of these drugs in a clinical trial (other than Phase IV) must be authorized through the submission of a CTA to Health Canada, including for each CTA-Amendment (CTA-A, see section 5.8 Amendment). The format and system where documents are retained should also be validated for its intended use. This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations). review of subject eligibility (inclusion/exclusion criteria), collection, assessment and reporting of (serious) adverse events (, biological samples (collecting, processing and shipment), any function requiring specific training (e.g. The Regulations came into force on September 1, 2001 and set out the federal requirements for the sale and importation of drugs used in human clinical trials in Canada, and include the requirement to comply with good clinical practices (GCP). (a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension; (b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that, (i) the situation giving rise to the intended suspension did not exist, or, (ii) the situation giving rise to the intended suspension has been corrected; and. Its purpose includes verifying the following: Section 5.18 of ICH E6 provides detailed guidance with respect to monitoring, including: The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. Health Canada expects that sponsors can demonstrate that the subject has read and understood the entire informed consent document(s). In situations where a sponsor undergoes a change of ownership, the record retention responsibility remains with the sponsor who initially submitted the, Appropriate measures should be taken to prevent accidental or premature destruction of the records (. identification of critical processes and data, risks associated with them (at both the system and clinical level), recording, managing and reporting of adverse events, storage and handling of clinical trial drugs, monitoring (that is, procedure that assures the quality of every aspect of the clinical trial), that the rights and well-being of human subjects are protected, that the reported trial data are accurate, complete, and verifiable from source documents, that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with, selection and qualification of monitors (, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used. As with any quality system documents, there needs to be a mechanism of approval, revision and communication of new and/or revised documents to those parties responsible for the procedures. Example of observation (refer to Glossary (terms) for definition of observation) typically cited under this section of the Regulations includes: Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in a therapeutic benefit for a human being. After reviewing the information or documents the sponsor provides, Health Canada would determine whether the situation giving rise to the intended suspension did not exist or has been corrected. Example of observation typically cited under this section of the Regulations includes: (g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks; The sponsor must ensure that all individuals involved with the clinical trial (e.g. When it is a site's common practice, the site's SOP for obtaining informed consent, must incorporate this process. (d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment. It is recommended that the QI inform a subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed (ICH E6, 4.3.3). This can include extensive clinical research training online, as well as taking a course or passing an exam to earn one of the many GCP certificates available. the information and documents in the application were either not provided in accordance with these Regulations or were insufficient to enable Health Canada to assess the safety and risks of the drug or the clinical trial, or. Every sponsor shall ensure that a clinical trial is conducted in accordance with GCP and shall ensure that at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the QI. During an inspection, Health Canada may verify that there is a system of traceability in place to ensure patient safety and that the computerized system, if applicable, is fully validated (refer to section 5.12 Records). Many parties usually share the responsibilities of record retention through delegation by the sponsor. Any documentation created and/or used during the conduct of clinical trials that allow the evaluation of the conduct of a study as well as the quality of the data produced during the study (ICH E6, 1.23). Good Clinical Practice Online Course Syllabus, Safety of Human Subjects in Clinical Research, Reporting Responsibilities of the Investigators, Ethics of Research Involving Mentally Incapacitated, Ethics of Research Involving Pregnant Women and Fetuses, Trial Management Data Handling and Record Retention, Common Terminology Used In Clinical Research, Commonly Used Abbreviations and Terms in Clinical Research. An REB should pay special attention to trials that may include vulnerable human subjects (elderly, children, mentally ill, prisoners, etc.). Note: Part C, Division 5 of the Regulations does not differentiate between a commercial and a non-commercial sponsor. Drugs that are sold and/or imported for the purpose of a clinical trial do not have to meet the regulatory requirements for a DIN (C.01.014) or a NOC (C.08.002 and C.08.003). (a) a copy of the protocol for the clinical trial; (b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial; (c) a clinical trial attestation, signed and dated by the sponsor's senior medical or scientific officer in Canada and senior executive officer, containing. (ii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given; (d) before the sale or importation of the drug, the sponsor maintains records concerning, (i) the information referred to in paragraph C.05.005(h), and. relative humidity, light, use of dry ice), level of control of storage conditions (e.g. Particular attention should be given to those aspects that are not routine clinical practice and that require additional training. This would include ensuring that all of the sponsor's obligations under Part C, Division 5 of the Regulations are met at each site, and that each site follows GCP. Good clinical practices (GCP): means 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. While only one copy of each document in archive must be retained, whether in hardcopy or electronic format, records from their original medium (e.g. The acceptability of such practice would have to be a decision based on a case-by-case basis as every effort must be made to obtain informed consent when the clinical trial subject is in an appropriate state of mind to make an informed decision with respect to his or her participation in the study. Health Canada will issue a new NOL within the 30-day review period. Section 5.20 of ICH E6 states that noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by a QI/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance. A qualified physician should be available to answer any medical questions that the subject may have regarding his/her participation in the study. Individual investigators at the clinical trial sites in Canada may serve as Canadian Importers (Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications). In interpreting the Regulations, ICH E6 should be used in conjunction with the Act, the Regulations, and any relevant policies and guidelines. The delegation log should be completed before commencement of the study and updated as necessary. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) FDA resource for E6 r2 addendum (also included in course) Good Clinical Practice Resource Guide. they are used as supportive medications for known clinical applications), normal values and/or ranges for test(s) included in the protocol, laboratory certification and/or accreditation, established quality control and/or external quality assessment, X-ray films, digital images, microfilms and compact disks. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, that is, the relationship cannot be ruled out. Sponsor: means an individual, corporate body, institution or organization that conducts a clinical trial. during staff meetings or seminars), events or materials provided by industry or clinical research associations, as well as educational institutions. Equipment or measuring devices used to generate critical data (e.g. (j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026.Footnote 1. If manufacturers cannot provide this stability data, then they must provide adequate rationale for why such testing was not done or arrangements must be made by the sponsor to ensure the drug is not exposed to temperature extremes (e.g. An awareness and understanding of the regulatory requirements (Part C, Division 5) pertaining to delegated trial-related duties is also recommended. drugs included on NOL). The sponsor did not implement systems and procedures to ensure the quality of the clinical trial. stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the pharmacokinetic profile of the product should be available prior to the use of the new formulation in clinical trials". The definition is broad in scope, and includes dispensing of drugs to subjects by physicians. Australia, Switzerland, Japan, European Union, United States), be used within the marketing authorization, unique code numbers assigned to the drug(s) and trial subjects, nature of the drug products (e.g. Part C, Division 5 of the Regulations provides for flexibility to follow international GCP standards in order to satisfy the requirements of the Regulations. ICH E6 does not define the word "drug", but section 1.33 defines "investigational product" (IP) as: "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 authorization 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.". Essential and/or source documents may be in paper, magnetic or electronic form (ICH E6, section 8). The use of the term "Principal Investigator" is commonly used to refer to an investigator that is leading a team of individuals conducting a trial at a site, and though would have the same meaning as qualified investigator (QI), "Principal Investigator" is not a legally defined term used in Canada. Phase IV clinical trials include those trials that involve the use of: Phase IV clinical trials are performed after the drug has been authorized by Health Canada for the market, and within the parameters of the authorized NOC or DIN application. Where multiple parties are involved in the distribution chain (e.g. These examples are provided for guidance and are not exhaustive. Some options to resolve this issue could be to send the ICF by mail or to document (e.g. The sponsor of a clinical trial is responsible for ensuring that a clinical trial drug is manufactured, stored and handled in accordance with GMP. Reporting of centralized monitoring activities should be regular and may be independent from site visits (ICH E6, 5.18.6). Refer to section 8 of ICH E6 for a more detailed list of essential and source documents. Good Clinical Practice (GCP) Frequency: every two years Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Observation: A deficiency or deviation from Part C, Division 5 of the Regulations noted by an Inspector during the inspection of a clinical trial that is confirmed in writing in the exit notice. Note that paragraph C.05.010(e) of the Regulations states that there be no more than one QI at each clinical trial site. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s) (ICH E6, 5.2.2). The alternate approaches to assure GMP compliance would be up to the sponsor to determine and could be considered by Health Canada. GMP also applies to the manufacture of drugs to be used in clinical trials. Beyond these introductory courses, many organizations also offer advanced certifications such as the Certified Professional Investigator credential for those who require more in-depth knowledge. 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