(2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless. 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). They consist of any piece of information that is created, modified, retrieved, and/or transmitted during the conduct of a clinical trial. (vi) any results of clinical pharmacokinetic studies of the drug, (vii) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials in humans, and. market authorized product vs. investigational drug), safety profile / history of use of the drug, calculations for clinical trial drug dispensing, clinical trial drug storage temperature logs, quantity dispensed, on what date and to whom, quantity returned by subjects, on what date, quantity and date of destruction or return to sponsor, drugs that are the subject of the clinical trial, and do not have market authorization, drugs that are the subject of the clinical trial, have market authorization, but are used off-label, comparator drug, if it does not have market authorization, comparator drug, if it has market authorization, but its labelling was changed (e.g. They are required to be submitted when changes are made to the study drug or the protocol that could affect the quality or safety of the study drug, or the risk to clinical trial subjects. (viii) if the drug is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor's representative in Canada who is responsible for the sale of the drug. Multiple sites may be identified by duplicating Part 3 of the CTSI form as many times as necessary to capture all site addresses. The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. Often, third parties (such as QIs, REBs, CROs) retain originals of specific and unique records created by them. In addition, if there is a specific level of accuracy that requires a certain equipment type, this may also be considered critical equipment. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. (ii) the information referred to in subparagraph C.05.005(c)(ix), if any of that information has changed since it was submitted; (e) before the sale or importation of the drug in accordance with the amended authorization, the sponsor ceases to sell or import the drug in accordance with the existing authorization; and. GCP serves as the international standard for designing, conducting, monitoring, documenting, analyzing, and reporting clinical trials. Section 7 of ICH E6 provides additional guidance on the content of an investigator's brochure. Good Manufacturing Practices (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, pharmaceutical, radiopharmaceutical, biological and veterinary products. Health Canada shall reinstate the authorization if, within 30 calendar days after the effective date of the suspension, the sponsor provides Health Canada with information or documents that demonstrate that the situation giving rise to the suspension did not exist or it has been corrected. ICH E6 elaborates on this definition in section 1.53 to include individuals, companies, institutions or organizations that take responsibility for the initiation, management and/or financing of a clinical trial. Protocols, case report forms (CRFs), and other operational documents should be clear, concise, and consistent (ICH E6, 5.0). At all times, where the Regulations exceed the guidance set out in this document or those in ICH E6, the Regulations take precedence. An REB should review and document a proposed clinical trial within a reasonable time and will document its views in writing, clearly identifying the trial, the documents reviewed and the dates for approval or disapproval (ICH E6, 3.1.2). Clinical Research Coordinator (CRC) Range: C$44k - C$69k. Canadian General Standard Board), the secondary medium allows the successful retrieval and use of the records for the entire 25-year record retention period, design to ensure the tracing of any alterations and updates, if permitted, such as source, date and content (i.e. - Be at least 18 years old In the event of the premature discontinuation of a trial, in its entirety or at a clinical trial site, for which a CTA or CTA-A has been filed in Canada, the sponsor is required to notify Health Canada (via CTA-Notification) as soon as possible, but no later than 15 calendar days after the date of discontinuance. Importer: The sponsor or person designated by the sponsor who is responsible for the import of the drug into Canada for the purpose of sale in a clinical trial. (a) the person is authorized under this Division; (b) the person complies with this Division and sections C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136, and C.01.435; and. the situation giving rise to the intended suspension did not exist, or. environmentally controlled areas, such as a hospital vs. office clinic), transportation container, packaging configuration, The drug was not manufactured in keeping with, The drug was not handled and stored in keeping with. In addition, in keeping with ICH GCP, the sponsor should expedite reporting of all SUADRs to all concerned QI(s)/institution(s), the REB(s) where required (ICH E6, 5.17.1). As per subsection C.05.008(4), if a sponsor needs to make an immediate amendment because the clinical trial or use of the drug endangers the trial subjects or other persons, the sponsor may make the amendment without prior review by Health Canada. The sponsor is ultimately responsible for all regulatory requirements regarding the conduct of the trial in Canada. proper documentation in the progress notes). The sponsor did not take reasonable measures to ensure the return of all unused quantities of the drug (including returns from the subjects) after a clinical trial being discontinued. All records should be kept in a secure location prior to, throughout and after the conduct of the clinical trial. 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. As such, ICH guidelines should be used in conjunction with the relevant federal regulations, guidance documents and any other regional, institutional or local requirements. (1) Subject to subsection (2), the Minister 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 the Minister has reasonable grounds to believe that. 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. The QI should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties (ICH E6, 4.1.5). Note: REBs in Canada are held to more stringent composition requirements than are described in this section for ICH E6. Section 4.11.1 of ICH E6 states that all serious adverse events (SAEs, as defined in Appendix A) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g. As an example, this principle would apply to radiopharmaceuticals. This would include for example certificates, calibration data, and records of faults, breakdowns and misuse of the equipment. (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug. 300, Qubec (QC) G1V 3X8, Canada, Basic understanding of the role of the ICH and its impact on conducting human clinical research according to GCP. There are many benefits of ICH GCP certification, including: - Have at least two years of relevant work experience ICFs submitted by sponsors to Health Canada are reviewed as part of their application for authorization to conduct a clinical trial. In those circumstances, the, device details (type, supplier, and purchase date). (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. Using a risk-based approach, the sponsor should identify critical equipment used in a study and specifications for that equipment (refer to section C.05.010(c) Equipment and Calibration). During this time, its important to keep up with continuing education through CCRPS or CITI GCP Training so that your training remains current. In Canada, a sponsor may transfer responsibility for any or all trial-related duties to other parties. The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society (ICH E6, 2.3). 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. USB keys). Site or trial site: The location(s) where trial-related activities are actually conducted (ICH E6, 1.59). During and following a subject's participation in a trial, the QI should ensure that adequate medical care is provided to a subject for any adverse events (AEs), including clinically significant laboratory values, related to the trial. The monitoring plan should reference the applicable policies and procedures (ICH E6, 5.18.7). In order to sell or import a drug for the purposes of a Phase I-III clinical trial, the sale or importation must be authorized by Health Canada through the submission of a CTA prior to the initiation of the trial or the implementation of the amendment. (e) at each clinical trial site, there is no more than one qualified investigator; A clinical trial site is the location where trial-related activities are conducted, such as the administration or dispensing of the drug (directly or by prescription) to the subject and where the subject returns for subsequent assessment (see site or trial site definition in Appendix A). Signing and dating a source document as evidence that it was reviewed is a common practice often supported by the site internal policies. The relevant Health Canada's Directorate (TPD or BGTD) should be consulted for further clarification. This applies also to marketed drugs used in clinical trials as investigational drugs and applies to all conditions required including ambient temperatures. Quality management includes the design of efficient clinical trial protocols and tools and procedures for data collection and processing, as well as the collection of information that is essential to decision making (ICH E6, 5.0). CTSI and QIU forms are not required to be updated for acting. 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. (d) For each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site; Health Canada's relevant regulations do include certain requirements related to REBs, but Health Canada does not have jurisdiction over how REBs conduct their operations or establish SOPs. If there is potential for the drug to be exposed to temperatures outside this range, manufacturers must be able to provide stability data, which proves the drug is not compromised in such conditions. The GRS Good Clinical Practice (GCP) Course is designed to prepare both investigators and research staff for the conduct of clinical trials with human participants. (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. 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). Note that Health Canada's Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications provides numerous examples of notifications. 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. 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. If a physician is identified on the clinical trial application (CTA) as the sponsor, he/she must assume the responsibilities of both the sponsor and the QI. For requirements regarding the reporting of adverse drug reactions (, written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of, Compliance and enforcement: Drug and health products, Good clinical practices: Guidance documents, Guidance Document: Part C, Division 5 of the Food and Drug Regulations Drugs for Clinical Trials Involving Human Subjects (GUI-0100) - Summary, Serious Unexpected Adverse Drug Reaction Reporting, Suspension and Cancellation (Intent to Suspend), Integrated Addendum to E6(R1): Guideline for Good Clinical Practice E6(R2), Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications, Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans, Clinical Trials Frequently Asked Questions (, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (, Guidance Document - Annex 13 to the Current Edition of the, Annex 11 to Pharmaceutical Inspection Co-Operation Scheme (, U.S. Code of Federal Regulations Title 21 Part 11 - Electronic Records; Electronic Signatures, Electronic Records as Documentary Evidence, CAN/, Notice to Stakeholders: Statement on the Investigational Use of Marketed Drugs in Clinical Trials, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (, Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry, Classification of observations made in the conduct of inspections of clinical trials (GUI-0043), Guidelines for Temperature Control of Drug Products during Storage and Transportation (, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, International Conference on Harmonization (. 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. It should also be performed in accordance with GMP principles and specific SOPs. Different types of records are created and are to be retained before, during and after the conduct of a clinical trial, in accordance with section C.05.012 of the Regulations and section 8 "Essential Documents for the Conduct of a Clinical Trial" of ICH E6. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki. What are the benefits of ICH GCP certification? The reconstitution or preparation of a clinical trial drug should be done in accordance with the clinical trial protocol and be documented. research for publication vs. drug submission for marketing authorization), status of the drug (e.g. The sponsor must also ensure that individuals remain qualified throughout all stages of the trial process, from trial design, to conduct of a trial at sites, through to the analysis of data and the preparation of final clinical trial reports (ICH E6, 5.4.1). Written agreements describing the procedures for records retention in accordance with the Regulations should be in place between all parties concerned. (iv) the medicinal ingredients of the drug. (3) The application for amendment referred to in subsection (1) shall contain a reference to the application submitted under section C.05.005 and shall contain the following documents and information: (a) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (e), a copy of the amended protocol that indicates the amendment, a copy of the protocol submitted under paragraph C.05.005(a), and the rationale for the amendment; (b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator's brochure or an addendum to the investigator's brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data; (c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the new information; and. Essential and/or source documents may be in paper, magnetic or electronic form (ICH E6, section 8). Package: includes any thing in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed. The information on the reconstitution or preparation of the drug, and the required storage conditions should be included in accompanying documentation. For electronic medical records system (e.g. Individual investigators at the clinical trial sites in Canada may serve as Canadian Importers (Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications). The sponsor did not keep records for the shipment, receipt, use, return and/or destruction of the drug. The drug was sold or imported for use in a clinical trial without receiving authorization from Health Canada. In the situation where a clinical trial is sponsored by an institution/ investigator, and the trial is conducted by a group of physicians at different sites, it is the institution/investigator identified on the CTA as the sponsor, who is required to monitor the trial at all investigative sites. A subject should sign an amended ICF no later than their next scheduled visit, if possible. Refer to section 5.2 (C.05.002, Application and its Interpretation), for a list of the provisions that govern a drug used in a Phase IV clinical trial. The frequency should be decided by the sponsor based on the specifics of the site and protocol. Also, if capable, the subject should sign and personally date the written informed consent (ICH E6, 4.8.12). NSF's GCP training course is a workshop with presentations, group discussions and case examples. It gives them the knowledge, skills, and confidence they need to ensure that their processes are compliant with good clinical practices. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. However, traceability to the manufacturing lot should be maintained on the label immediately attached to the investigational drug (i.e. 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.). Current and continuing certification in Transportation of Dangerous Goods is an asset. A QI may also identify 'sub-investigator(s)' (physician or dentist who meets the criteria of a QI) who can, for short absences only, assume the qualified investigator's full responsibilities. It should be noted that other marketed drugs to be used in a trial which are not indicated on the NOL (and thus, are not considered investigational drugs) must: For additional information, refer to the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications. This course is based on the international E6 ICH Good Clinical Practice regulations and is a complete training solution for all individuals that need to acquire GCP knowledge. 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. The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication. #779602-1). Subjects must be presented with any REB approved amended ICFs at their earliest visit to the clinical trial site and re-consented as soon as possible, unless there are specific recommendations from the sponsor and/or REB. 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 regulatory obligations to obtain the REB approval are the responsibility of the sponsor. The valid expiration date assures that the drug meets the standards for potency, purity and physical characteristics. 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. - Global recognition (a) inform the Minister no later than 15 days after the date of the discontinuance; (b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor; (c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and. The REB membership is defined in section C.05.001 of the Regulations (refer to Appendix A) and may be reviewed during the inspection, as required. The purpose of having a lot number on a drug label is to ensure traceability back to the manufacturer's records, in the event a problem with the drug is identified or a recall is necessary. The 'Good Clinical Practice (GCP) in Australia' online training course is specifically designed to assist clinical researchers within Australia understand the principles and foundations of GCP. The above conditions apply to transfers of essential records from an original to a secondary medium performed by all parties involved in the conduct of a clinical trial. For clinical trials requiring the filing of a CTA to Health Canada (Phase I-III), compliance with this paragraph is determined at the time of CTA review by the appropriate Directorate (TPD or BGTD) of Health Canada. It is important to assess the protocol deviations for impact analysis and root cause analysis. Serious adverse drug reaction (SADR): means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (2) For the purposes of subsection (1), amendments are. printing). (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification. Complete guidelines for the transportation and storage of clinical trial drugs can be found in the Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069) and the ICH guideline Q1A(R2) on Stability Testing of New Drug Substances and Products. through use of passwords), plan in place for future accessibility (in light of changes over time in technology, personnel, or third-party contractors), location of records that permits immediate access to records for inspection. However, the sponsor must notify Health Canada of the change, and submit a CTA-A within 15 calendar days after the date of implementation of the amendment. (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. A detailed list of essential/source records which specifies the party(ies) who should retain them, and where they should be located throughout the period of a trial, is described in section 8 of ICH E6. Written procedures for this process should be followed. The sponsor did not inform Health Canada within 15 days of a clinical trial being discontinued. Documentation of training should include the content of the training such as the learning objectives, who attended and when the training occurred. receiving drug shipment directly from outside of Canada) is identified on Appendix 1 of the Drug Submission Application Form (. It is recognised across the globe and is a requirement for working in the clinical trial industry. To become ICH GCP certified, you must pass an examination that tests your knowledge of the global standards for the ethical conduct of clinical trials. The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected. For enquiries,contact us. (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator; The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. Organizations LEARN MORE Learners EXPLORE COURSES Questions? The clinical trial records had errors and/or missing information that did not allow for complete and accurate reporting, interpretation, and verification. Follow-up reports of fatal or life threatening reactions must include an assessment of the importance of the event and the implication of any findings, including relevant previous experience with the same or similar drugs. Becoming ICH GCP certified can open up new possibilities in furthering your career! If Health Canada has suspended an authorization, Health Canada shall: Section 4.12 of ICH E6 sets out the responsibilities of a QI/institution in the event of premature termination or suspension of a clinical trial. In addition, the improper maintenance of transportation and storage temperatures may result in a loss of efficacy of the drug or affect the safety of the drug. The QI must have a documented SOP in place for obtaining informed consent. If a drug or substance is prohibited under the Regulations (refer to section C.05.003), a sponsor may submit a CTA to sell and/or import the drug for use in a clinical trial if the sponsor is able to justify that its use may result in a therapeutic benefit to human subjects. The use of the term "protocol" is consistent with ICH E6, 1.44. 8. Sponsors should be rigorous in their dealings with contracted third parties, including contract research organizations (CROs), to ensure that sponsor's obligations are met. Only a licensed physician or dentist (if for dental purposes only) is entitled to provide health care under the laws of the province where that clinical trial site is located can assume the role of a QI. 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. The relevant Health Canada Directorate (TPD or BGTD) should be consulted for further clarification. The sponsor of a clinical trial is responsible for ensuring that a clinical trial drug is manufactured, stored and handled in accordance with GMP. However, because Phase IV studies are to be conducted in accordance with GCP, which includes good manufacturing practices (GMP) requirements, they may be subject to inspection. You will not receive a reply. 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. (b) in any other case, a physician and a member in good standing of a professional medical association. (c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b). ICH E6(R1) was amended in November 2016 to ICH E6(R2) to: The ICH guidance Integrated Addendum to E6(R1): Guideline for Good Clinical Practice E6(R2) was fully adopted by Health Canada as of April 3, 2019. Part C, Division 5 of the Regulations provides for flexibility to follow international GCP standards in order to satisfy the requirements of the Regulations. In the context of clinical trials, a drug would include a drug for human use that is to be tested in a clinical trial and includes pharmaceuticals, biologics, gene therapies, blood products, vaccines and radiopharmaceuticals (Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications). (viii) if the drug is a radiopharmaceutical as defined in section C.03.201, information regarding directions for preparing the radiopharmaceutical, the radiation dosimetry in respect of the prepared radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical; (f) if the drug contains a human-sourced excipient, including any used in the placebo, (i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or. The manual calibration of certain pieces of equipment or instruments (e.g. The qualification should be appropriate to the tasks to be performed by the individual. Health Canada will issue a new NOL within the 30-day review period. After you pass our ICH GCP certification course you are equipped with the knowledge and skills needed to work in the clinical trial industry. In order to allow traceability of all source data, any source documents should be signed and dated by the person collecting, recording, reviewing and/or assessing the information or data. Method of Training: Online / Self-paced eLearning. Research ethics board (REB): means a body that is not affiliated with the sponsor, and. E-mail: hc.ich.sc@canada.ca. 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. The clinical trial drug was not used as prescribed in the protocol. Abbreviation: A shortened form of a word or phrase (for example, "e.g." Labeling of a clinical trial drug with a manufacturer's lot number may compromise a blinded clinical trial. Paragraph C.05.005(e) of the Regulations describes the content that must be included in an investigator's brochure that is submitted to Health Canada. Average: C$54,074. 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). The ICF must be made available for each subject in either official language or other as appropriate. As per section C.05.012 of the Regulations, records of the clinical trial drug's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused clinical trial drugs, should be available in order to demonstrate traceability. Retention of copies of original documents is not a requirement. The ICF should be paginated to ensure that the complete document is presented to the subject. 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. For an outline of UHN's Good Clinical Research Practice training program please click HERE. 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. (a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and. 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. Additional Resources: Supplemental materials/activities. Limited access or passwords should be used accordingly. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The Regulations clearly establish that the sponsor has the overall responsibility for conducting a clinical trial involving drugs in human subjects. (c) if the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug. (b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned. (i) the physical, chemical and pharmaceutical properties of the drug. (iii) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested. The sponsor did not receive ethics approval for amendments to an existing clinical trial before implementing the amendments at the clinical trial site. For blinded clinical trials, the sponsor should ensure that the labelling does not compromise the blinding. commercial vs. non-commercial), purpose of the clinical trial (e.g. The quality management system should use a risk-based approach as described in sections 5.0.1 to 5.0.7 of ICH E6. (2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies. Part C, Division 5 of the Regulations clearly establishes that the sponsor who submits the CTA is the party to whom an authorization to sell or import a drug for use in a clinical trial is issued. Please refer to the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for detailed guidance on the application process. The definitions for SADR and SUADR are consistent with those found in sections 1.50 and 1.60 of ICH E6. (B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading; (d) 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 the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application; (e) an investigator's brochure that contains the following information, namely. If stability studies to support expiry dating for a clinical trial drug are still ongoing at the time of labelling, the following may be considered acceptable in lieu of an expiration date: The above process should be documented; procedures and quality control systems should be in place and in accordance with the approved CTA. If the sponsor discontinues the drug development, the sponsor must notify Health Canada, all the trial QIs/institutions and other regulatory authorities who may be involved (ICH E6, 5.5.9). 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). The sponsor did not get written inform consent for every person before they participated in the clinical trial or the amended clinical trial. Additional guidance on the selection and qualification of auditors, as well as auditing procedures, can be found in sections 5.19.2 and 5.19.3 of ICH E6. Prior to implementation of a CTA-A at a site, a qualified investigator should obtain documented approval from the REB (ICH E6, 4.5.2). Health Canada shall also suspend an open trial as a result of an inspection with a "non-compliant" (NC) rating if Health Canada reasonably believes that any of the circumstances outlined in C.05.016 (1)(a) through (d) apply. 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. 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. 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 requirements of section C.05.011 would not apply in this case. data managers, biostatisticians). the sponsor for agreement, and, if required, the regulatory authority (i.e. The sponsor did not notify Health Canada within 15 days of making a change to the protocol that does not alter the risk to the health of a clinical trial participant. The sponsor must have data to support the shelf-life of the drug. If there is a conflict with a definition in the Food and Drugs Act or associated regulations, the definition in the Act or regulations prevails. To become certified, you must complete either GCP course training or Clinical Research Training Online, which can give you valuable knowledge about relevant ICH GCP regulations and standards. Good clinical practices: Guidance documents - Canada.ca Good clinical practices: Guidance documents Guidance Document: Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100) Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043) Program/Course ID: GCPFP. Records relevant to a clinical trial that pertain to the roles and responsibilities of the REB should be retained for 25 years in accordance with Part C, Division 5 of the Regulations. Institution/Investigator-Sponsored Clinical Trials. It is important to note that local regulations in ICH regions can exceed the requirements of ICH E6. They are recognised across the globe and form the basis for national and regional regulations governing clinical research. Health Canada expects these components to be clearly documented in risk-based monitoring plans. Acronym: An identifier formed from the initial letter of each word in a phrase or compound term (for example, "CTA" represents "Clinical Trial Application"). Note that paragraph C.05.010(e) of the Regulations states that there be no more than one QI at each clinical trial site. Where a third party, such as a contract research organization (CRO) or a site management office (SMO), has been delegated by written contract to carry out some or all of the sponsor's responsibilities, they must also demonstrate adherence to the applicable regulatory requirements. Factors to be taken into consideration by the sponsor when determining the approach for storage and transportation may include, but are not limited to: Inadequate transportation and storage conditions may affect a sponsor's ability to trace a clinical trial drug as well as have an impact on the quality and safety of the clinical trial drug. 20 reviews. measures are in place to verify that the transfer is accurate and done by appropriately trained individuals (e.g. The alternate approaches to assure GMP compliance would be up to the sponsor to determine and could be considered by Health Canada. Home > Training Programs > GCP Fundamentals. pharmacy, CRO, central warehouse) the sponsor should ensure that the role of each party is clearly outlined in writing. Health Canada shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at an individual clinical trial site, and the reason for the suspension. These examples are provided for guidance and are not exhaustive. The immediate reports should be followed promptly by detailed, written reports. 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). Import: means to import a drug into Canada for the purpose of sale in a clinical trial. This could be either the QI, or adequately qualified individual to whom the QI has delegated the activities. This is especially valuable when there are a large number of amendments and/or subjects enrolled in a study. However, there may be Sub-Investigators/Co-Investigators in the study under the supervision of a QI. The Regulations clearly establish that the sponsor has the overall responsibility for conducting a clinical trial involving drugs in human subjects, including that the clinical trial be conducted in accordance with GCP [C.05.010(a) to (j)]. (c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented; The sponsor, whether commercial or academic, is responsible for the establishment of a quality system consisting of documented procedures (standard operating procedures (SOPs), protocol procedures, etc.) There must be no more than one (1) QI at each clinical trial site. A method is expected to be in place to identify those data elements requiring source documentation, and sites can then declare the type of source documents (e.g. (b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008. The sponsor should establish and maintain a system to ensure that investigational drugs can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the QI/clinical trial site where the product is used, administration of the drug to clinical trial subjects, to the reconciliation and disposal or destruction of the drug. 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". (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division; The sponsor must ensure that the clinical trial is conducted in accordance with the requirement of the protocol, which has been authorized by Health Canada and approved by REB(s). The validation results should provide a clear indication that the system can be used as created. How long does it take to become ICH GCP certified? It is recognized that the scope and subject matter of current Health Canada guidances may not be entirely consistent with those of the ICH guidances that are being introduced as part of our commitment to international harmonization and the ICH Process. ICH E6 does not make reference to importation of clinical trial drugs. ICH GCP certification is a credential that demonstrates you have met the set of global standards for the ethical conduct of clinical trials. Clinical trial application-Amendments (CTA-As) are applications in which a sponsor submits information to support changes to a previously authorized clinical trial. ICH-GCP certification involves completing a specific training course to demonstrate knowledge and understanding of Good Clinical Practice principles. 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. the information and documents supplied were not provided in accordance with the Regulations, insufficient information was provided to enable Health Canada to assess the safety and risks of the drug or the clinical trial. Informed consent is documented by means of a written, signed and dated informed consent form (ICF) (ICH E6, 1.28). This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. In accordance with paragraph C.05.005(a) of the Regulations, the application by a sponsor to sell or import a drug for the purpose of conducting a clinical trial in Canada must submit a protocol as part of their application. These records could include, but are not limited to: Other essential documents that are not unique to the REB (e.g. Adverse drug reaction (ADR): means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. Sale or importation of a drug for the purposes of a Phase I-III clinical trial is contingent on the following: Reasons why sponsor may get a Not Satisfactory Notice (NSN) could include: A sponsor does not have to submit a CTA for authorization to sell or import a drug used in a Phase IV clinical trial. It is acceptable for a marketed drug used in a clinical trial as comparator (refer to Glossary (terms) for definition of comparator), to be labelled in accordance with its marketing authorization (NOC/DIN), including all relevant sections of the Food and Drugs Act and its associated regulations, provided that the labelling on the marketed drug is appropriate for the trial. For additional guidance on risk-based quality management in clinical trials, the sponsor may consult other international guidelines (See Appendix B - References, Other Guidances and Policies). thermal paper used for electrocardiograms), certified copies can be acceptable (see "Transfer of records to secondary medium" section below). The sponsor did not record, handle and store all information for a clinical trial to ensure the data transcribed from the original documents to case reports was accurate and complete. The course is self-paced and takes approximately six . The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. The sponsor did not implement systems and procedures to ensure equipment was maintained and calibrated. Any equipment or measuring device used to generate data that is reported on the case report form (CRF) should be assessed by the sponsor, and requirements for range and accuracy should be determined. The Regulations apply to the sale and importation of drugs to be used in clinical trials involving humans that are conducted in Canada. For additional information, refer to the U.S. Food and Drug Administration (FDA) Guidance for Industry - Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring published in 2013. The responsibility of a REB is to protect the rights, safety, and well-being of all human subjects. The relevant Health Canada Directorate (TPD or BGTD) should be consulted for further clarification. It is critical that quality control be applied at each and every stage of data handling to ensure that all data are reliable and have been processed correctly (ICH E6, 5.1.3). There are a number of requirements for obtaining ICH GCP certification, including: (ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator, if known at the time of submitting the application, (x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and, (A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and. the statements of risk submitted to Health Canada are included, additional and specific requests from Health Canada and/or the, any new information concerning the safety of the patients/subjects has been included, the subjects have been informed of this information in either official languages, or other as appropriate, the information must be kept for 25 years [C.05.012(4)]. (2) Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of, (a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or. Amendments must be authorized by Health Canada prior to implementing the changes. The acronym SUSAR (Suspected unexpected serious adverse reaction) is often used to identify serious adverse reactions that require reporting to a regulatory authority. The retention period for all records created and/or used during the conduct of a clinical trial is 25 years in accordance with subsection C.05.012(4) of the Regulations. The QI should sign and date the log prior to a task being delegated. represents "Example"). 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. Written procedures and training of personnel in their implementation should be documented to demonstrate that the maintenance and retention of records was conducted correctly and consistently. Our free GCP training can also serve as a refresher course. Please refer to the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for detailed guidance on the application process and Phase IV studies classification. (PDF format, 794 KB, 99 pages). (d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold. Electronic records should be maintained and retained in accordance with section C.05.012 of the Regulations. Where multiple parties are involved in the distribution chain (e.g. Health Canada may require a sponsor to submit, within two (2) calendar days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make a determination for issuance of the NOL. It should be noted that it is not a requirement for a party to retain multiple and identical copies of an original document. For detailed guidance on clinical trial applications (CTA) and amendments (CTA-A), you should refer to Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications and if applicable, to Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans. The sponsor did not keep complete and accurate records to show the clinical trial was conducted in keeping with. This is followed by Health Canada's interpretation (what should be done in order to be compliant). 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. The sponsor is responsible for ensuring that the labelling of a clinical trial drug meets the requirements of section C.05.011 of Part C, Division 5 of the Regulations. As long as a label provides all of the required information in both official languages, it would be considered to have met the requirements of section C.05.011 of the Regulations. Identifiers other than a "lot" or "(L)" number (e.g. The process can be incorporated into an existing SOP for obtaining informed consent or be a stand-alone procedure. 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 accordance with subsection C.05.002(2), the sponsor of a Phase IV clinical trial does not have to file a clinical trial application (CTA) for importation and/or sale of the study drug. Procedures which are routine (e.g. Failure to provide any or adequate information within 30 calendar days after the effective date of suspension will result in cancellation of the authorization, either in its entirety or at a clinical trial site, as the case may be. This means that activities which fall under the purview of medical care must be conducted by qualified, licensed physician or dentist, within their scope of practice/expertise. Any member of the Mutual . type of research (e.g. The sponsor did not keep complete and accurate records for the use of the drug in a clinical trial, as required by the Regulations. (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. 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