The ICH-GCP is an internationally accepted standard that covers the manufacture and trials of approved drugs. (iv) the medicinal ingredients of the drug. - Have at least two years of relevant work experience A subject should sign an amended ICF no later than their next scheduled visit, if possible. Drugs may be shipped directly from a foreign provider (manufacturer, distributor, etc.) 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. 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. to perform critical trial-related procedures and/or to make important trial-related decisions (i.e. Written agreements describing the procedures for records retention in accordance with the Regulations should be in place between all parties concerned. to a clinical trial site in Canada provided that: If 30 days have passed and no NOL was obtained, specific requests to import clinical trial drugs should be directed to the Health Product Border Compliance Program at the following generic email account: hc.hpbcp-pcpsf.sc@canada.ca. It is recommended that the label for any new packaging of the drug carry an expiration date. body weight scales) does not generate a certificate or a print-out of the calibration data to demonstrate that the calibration was indeed performed and successful. This could be through initialing each page of the ICF, or a statement included at the end stating that the subject has read and understood all the pages. Current and continuing certification in Transportation of Dangerous Goods is an asset. Health Canada may request that a sponsor submit either information or samples of a study drug if the information and documents submitted are insufficient to assess the quality and safety of the drug to be used in the clinical trial. inclusion/exclusion criteria) and/or significantly affecting the safety and well-being of the subjects, as well as data quality and integrity should be considered critical equipment. in the monitoring plan). GMP also applies to the manufacture of drugs to be used in clinical trials. These guidelines apply not only to drugs that require refrigerated or frozen transportation and storage temperatures, but also those that must be transported and stored at ambient temperature. Compliance with the Regulations and ICH E6 will further promote the protection of subjects as well as ensure the integrity of the data generated by the trial, whether it is for use in academic publications, or to support new, supplementary or abbreviated drug submissions (NDS, SNDS, ANDS). Clinical Research Coordinator (CRC) Range: C$44k - C$69k. Consistent with, but further expanded on in section 1.24 of ICH E6, which defines GCP as: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible, accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.". 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. GCP serves as the international standard for designing, conducting, monitoring, documenting, analyzing, and reporting clinical trials. hardcopies) should be kept for as long as they are needed. The acronym SUSAR (Suspected unexpected serious adverse reaction) is often used to identify serious adverse reactions that require reporting to a regulatory authority. The impact of such a change should be evaluated and documented, and partial validation of some components of the electronic system may be required. All references to a sponsor in this guidance document also apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a sponsor (ICH E6, 5.2.4). Protocols, case report forms (CRFs), and other operational documents should be clear, concise, and consistent (ICH E6, 5.0). In these instances, a log should be kept with all of the information listed under the bullet point above; except it should include the name of the person who assessed the calibration data and certified that calibration was successful, instead of the person who calibrated the instrument. 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.). thermal paper used for electrocardiograms), certified copies can be acceptable (see "Transfer of records to secondary medium" section below). Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data. NSF's GCP training course is a workshop with presentations, group discussions and case examples. 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 Canadian Association of Clinical Research Specialists (CACRS) is a federally registered professional association in Canada (Reg. Please note: This course is the only ACRP eLearning course with a completion certificate that includes an expiration date. After completion, participants receive a GCP training certificate which indicates their awareness and understanding of ICH-GCP requirements. (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. 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. CTSI and QIU forms are not required to be updated for acting. As part of a quality system, a sponsor is also responsible for securing an agreement from all involved parties to ensure direct access (see ICH E6, 1.21) to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor themselves, and inspection by regulatory authorities, both domestic and foreign (ICH E6, 5.1.2). If a trial is prematurely terminated or suspended for any reason, the QI/institution should: If a QI terminates or suspends a trial without prior agreement of the sponsor: If a sponsor terminates or suspends a trial (see ICH E6, 5.21): If the REB terminates or suspends its approval/favourable opinion of a trial (see ICH E6 3.1.2 and 3.3.9): In addition to those requirements set out in the Regulations with respect to the discontinuance, suspension or cancellation of authorisation to sell or import a drug for the purpose of a clinical trial, section 5.21 of ICH E6 states that in the event of such an occurrence, the sponsor should: This can be done by either the sponsor or the QI/institution, as specified by the applicable regulatory requirement(s). (ii) the pharmacological aspects of the drug, including its metabolites in all animal species tested. This section also lists the documents that should be provided to an REB in order to obtain ethics approval to conduct a clinical trial. Fortunately, there are a number of ICH GCP certification courses available that start from as little as a few hundred dollars, ensuring that everyone has access to the training they need. However, a marketed comparator drug used off-label must comply with the requirements of section C.05.011, unless it was not considered to be investigational in the context of the particular clinical trial, based on the assessment of the application. The definitions for SADR and SUADR are consistent with those found in sections 1.50 and 1.60 of ICH E6. 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. 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. The responsibility of a REB is to protect the rights, safety, and well-being of all human subjects. Guidance on interpretation of Part C, Division 5 of the Regulations is provided in this document. 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. (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. For electronic medical records system (e.g. As per section 5.1.1 of ICH E6, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and all applicable regulatory requirements. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake. This practice would allow the subject to consent and start the trial at the same time. After training, you will receive your Good Clinical Practice Certificate or GCP Certificates that require annual renewal. 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). These timelines should be taken into consideration when determining the location of the clinical trial records for the retention period. As per section 4.8.15 of ICH E6, in emergency situations, when prior consent of the subject is not possible, the consent of the subject's legally acceptable representative (as defined by provincial requirements), if present, should be requested. Site personnel should not conduct study specific tasks until the QI has documented the delegation and appropriate training has been completed. 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. ICH E6 uses the terms "institutional review board" (IRB) and "independent ethics committee" (IEC) interchangeably, the definition of which is consistent with that of an REB. These definitions are expanded on in ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A). The use of electronic ICFs is generally considered acceptable if all applicable regulatory and ICH requirements are met. Drug accountability records are required for: Drug accountability records are not required for: For example, marketed drugs which are commercially available, for which no CTA has been filed (Phase IV), should be managed as commercial drugs and good practice guidelines for pharmacies followed. This additional labelling information should be properly documented in both the trial documentation and in the packaging records. Range: C$63k - C$125k. (a) amendments to the protocol that affect the selection, monitoring or dismissal of a clinical trial subject; (b) amendments to the protocol that affect the evaluation of the clinical efficacy of the drug; (c) amendments to the protocol that alter the risk to the health of a clinical trial subject; (d) amendments to the protocol that affect the safety evaluation of the drug; (e) amendments to the protocol that extend the duration of the clinical trial; and. a manufacturing date is listed on the label, as long as the clinical trial site where the drug is dispensed has a document from the sponsor documenting the shelf-life of the drug. It reviews: Defines and puts into practice GCP while demonstrating: 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. When it is a site's common practice, the site's SOP for obtaining informed consent, must incorporate this process. 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. sub-investigators). Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) (ICH E6, 5.17.2). "Post-Authorization Requirements" of the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for further information. data managers, biostatisticians). The risk evaluation should be related to the significance of the data in the trial. Import: means to import a drug into Canada for the purpose of sale in a clinical trial. All records should be kept in a secure location prior to, throughout and after the conduct of the clinical trial. 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 Regulations apply to the sale and importation of drugs to be used in clinical trials involving humans that are conducted in Canada. (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall. Amendments must be authorized by Health Canada prior to implementing the changes. Evidence of this timely oversight may be assessed during an inspection through the review of signatures and file notes on source data and CRFs, including electronic signatures where applicable, and through interviews with study staff and the QI. 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. 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. It would be up to the sponsor to determine how to comply with the labelling requirements set out in this provision, provided that the system in place is validated, traceable, and does not compromise patient safety or product quality. On-site monitoring is performed at the sites at which the clinical trial is being conducted. The definitions outlined in this section are available in Appendix A. In addition to monitoring, a sponsor may perform audits of trials. All drugs included on the NOL are considered investigational and thus, must be in compliance with Part C, Division 5 of the Regulations. Our free GCP training can also serve as a refresher course. The delegation log should be completed before commencement of the study and updated as necessary. in order to assure the quality of every aspect of a clinical trial, in accordance with the Regulations and ICH E6. 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. Some options to resolve this issue could be to send the ICF by mail or to document (e.g. In accordance with section C.05.014 of the Regulations, it is the responsibility of a sponsor to inform Health Canada, in an expedited manner, of all SUADRs in respect of a drug during the course of a Phase I-III clinical trial (refer to the boxes below for Phase IV trials), whether or not the event occurred inside or outside of Canada: In cases where the event is fatal or life threatening, the sponsor must submit a complete report to Health Canada within 8 calendar days after the first notification (initial report) to Health Canada of the event. The sponsor is ultimately responsible for all regulatory requirements regarding the conduct of the trial in Canada. 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. 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. Further guidance respecting information and records can be found in this document under section 5.12 Records (C.05.012). 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 subject or the subject's legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate (see ICH E6, 4.8.10) should be requested. If the drug product is stored in a controlled environment at the clinical trial site according to the information on the label, a risk-based approach will be used. Where multiple parties are involved in the distribution chain (e.g. The sponsor should document the rationale for the chosen monitoring strategy (e.g. The relevant Health Canada Directorate (TPD or BGTD) should be consulted for further clarification. The sponsor is required to maintain complete and accurate records to demonstrate that the clinical trial is conducted in accordance with the Regulations and GCP (ICH E6, 5.5.6-7). Certification and practice Canada. 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. 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). The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication. Please refer to the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for detailed guidance and/or consult the Clinical Trials Frequently Asked Questions (FAQs) for further details and information on QIU and CTSI forms. The labelling must comply with regulatory requirements of section C.05.011 and be coded in a manner that protects the blinding, if applicable (ICH E6, 5.13.1). In general, Health Canada does not focus its inspection activities on Phase IV trials. ensure the credibility of clinical trial data. Multiple sites may be identified by duplicating Part 3 of the CTSI form as many times as necessary to capture all site addresses. As per section C.05.005, this person is the sponsor's senior medical or scientific officer residing in Canada who is responsible for providing an attestation with respect to the CTA/CTA-A at the time of filing. The documentation regarding GMP compliance should be kept by the sponsor. A sponsor may also not sell or import a drug for the purpose of any clinical trial, including Phase IV clinical trials, if the trial has been suspended or cancelled under either C.05.016 or C.05.017. 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. Supplementary information like quotes and legal references. Third parties should consult the sponsor prior to destroying any record. 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). Equipment used in the study classified as medical devices must be licensed in Canada for Class II, III and IV or have an Investigational Testing Authorization (ITA) for use in that study and must be in compliance with the Medical Devices Regulations. 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. It is recognised across the globe and is a requirement for working in the clinical trial industry. There must be no more than one (1) QI at each clinical trial site. Accurate, reliable salary and compensation comparisons . 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. 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) introduction to ich gcp . E-mail: hc.ich.sc@canada.ca. 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. (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. (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. A request for clarification or information may be required if the information and documents submitted in a CTA, or a CTA-A, were insufficient in either of the following ways: Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that. 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. (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. For more information on computerized system validation, refer to section 5.12 Records (C.05.012) of this document. (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. OR complete an accredited training programme, The process for obtaining ICH GCP certification includes: 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. This definition is consistent with section 1.12 of ICH E6. The label of the drug did not contain the required information. 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. The sponsor did not implement systems and procedures to ensure that staff was adequately trained on. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.". A type of essential document that consist of original documents, data, and records (ICH E6, 1.52). For example, if the sub-investigators are only doing follow-up visits and the QI is still able to oversee these activities, proper delegation and description of activities at both locations should be sufficient hence, no CTSI form should be filed for the other location. Additional information regarding the requirements pertaining to GMP for clinical trial drugs is available in Guidance Document - Annex 13 to the Current Edition of the GMP Guidelines: Drugs Used in Clinical Trials (GUI-0036), as well as sections 2.12, 5.14 and 8.2.16 of ICH E6. 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. 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. audit trail), security measures in place and documented to protect against data corruption, whether through accidental deletion, equipment failures, material deterioration, or a variety of other hardware and software problems, controlled access to appropriate individuals (e.g. 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 collection, assessment and reporting of adverse events (AEs, as defined in Appendix A) is a critical component of the conduct of any clinical trial. (4) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment. #779602-1). The relevant Health Canada Directorate (TPD or BGTD) should be consulted for further clarification. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. Sponsor-Investigator) and as such, the same requirements apply. For enquiries,contact us. ICH-GCP certificate makes you equipped to conduct ethical clinical studies while protecting the rights and safety of human subjects. Registering for an examination with an accredited organization like CCRPS As such, access to the records should be restricted to authorized personnel that are adequately trained in the handling and management of clinical trial records according to an established documented procedure. It is suitable for anyone carrying out, or involved in, clinical research and clinical trials. Written procedures for this process should be followed. 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. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. 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. Refer to section 8.7 of Guidance Document - Annex 13 to the Current Edition of the GMP Guidelines: Drugs Used in Clinical Trials (GUI-0036) for additional guidance. All service, maintenance, cleaning and calibration records, as well as the product manual for a critical piece of equipment used in the clinical trial, should be retained for the 25-year record retention period. Many parties usually share the responsibilities of record retention through delegation by the sponsor. Considerations should be given to additional requirements that may apply to the destruction of personal/confidential information. 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. Why Should You Complete the Good Clinical Practice (GCP) in Australia Course? When third parties have been delegated some of a sponsor's responsibilities, written agreements should be in place to clearly set out the division of responsibilities. The relevant Health Canada Directorate (TPD or BGTD) should be consulted for further clarification. Where it is not possible to comply with both sets of requirements, the federal Regulations would govern and the records must be maintained for 25 years. However, traceability to the manufacturing lot should be maintained on the label immediately attached to the investigational drug (i.e. printing). For enquiries,contact us. When prior consent of the subject is not possible, and the subject's legally acceptable representative is not available, enrolment of the subject should require measures described in the protocol and/or elsewhere, with documented approval by the REB, to protect the rights, safety and well-being of the subject, and to ensure compliance with applicable regulatory requirements. 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. This could be either the QI, or adequately qualified individual to whom the QI has delegated the activities. (2) The Minister 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 a clinical trial site and the reason for the suspension. 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). 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. (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. Job Title: Clinical Project Manager. (f) amendments to the chemistry and manufacturing information that may affect the safety or quality of the drug. - Higher earning potential Experience Minimum of one year of experience within the last three years working in a research setting including data entry and laboratory processing is required. Improve site activation time and reduce training time with mutually-recognized, effective, engaging training. 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. It should be noted that it is not a requirement for a party to retain multiple and identical copies of an original document. There are many benefits of ICH GCP certification, including: The Regulations clearly establish that the sponsor has the overall responsibility for conducting a clinical trial involving drugs in human subjects. Clinical trial application-Amendments (CTA-As) are applications in which a sponsor submits information to support changes to a previously authorized clinical trial. These records include, but are not limited to: Drug accountability records should include the following information on the drug, but not limited to: In order to ensure that subjects received the product(s) according to their randomization, QIs should maintain documentation. Health Canada recommends that REBs overseeing clinical trials in Canada operate according to well established and recognized standards such as the ICH E6, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2 2014), and provincially established standards. The Regulations do not differentiate between a commercial and a non-commercial sponsor (e.g. Informed consent is defined as a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate (ICH E6, 1.28). Sections C.02.019, C.02.025 and C.02.026 refer to drug testing and sample retention. It is a sponsor's responsibility to keep records of all AEs in respect of the drug used in a clinical trial, whether those events occur inside or outside of Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the AE [C.05.012(3)(c)]. a change to the protocol that does not alter the risk to the health of a clinical trial subject. (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. Should you have any questions or comments regarding the content of the guidance, please contact: Health Canada - ICH Coordinator The procedures may be trial- or site-specific and be provided by the sponsor or the third party that was delegated the responsibility. If the sponsor chooses to maintain biological study samples (e.g. Training should be relevant to the study related duties performed by personnel, and include, at a minimum the relevant sections of trial protocol for which the person is responsible, as well as relevant supporting guidance, including, but not limited to ICH E6. The manual calibration of certain pieces of equipment or instruments (e.g. All agreements made by the sponsor with the investigator/institution and any other parties involved with the clinical trial should be in writing as part of the protocol or in a separate agreement (ICH E6, 5.1.4). Electronic signatures are considered acceptable, again only if the electronic system is fully validated. 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)]. The electronic system should allow for the retrieval of the records, the generation of complete and accurate paper copies of the electronic source data as well as provide audit trails for the entire 25-year record retention period. 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. (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month: (ii) the date after which the manufacturer recommends that the active ingredient not be used. This institution/investigator assumes the responsibilities of both the sponsor and the qualified investigator. (5) A sponsor may not sell or import a drug for the purposes of a clinical trial. They consist of any piece of information that is created, modified, retrieved, and/or transmitted during the conduct of a clinical trial. The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. 5. sponsor . minors or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject's understanding. (C) the objectives of the clinical trial will not be achieved; (c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); and. Label: includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. Note that paragraph C.05.010(e) of the Regulations states that there be no more than one QI at each clinical trial site. 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. during study start-up meetings), site-initiated training (e.g. UHN is one of the Member Companies of the TransCelerate Mutual Recognition Program for ICH E6 Good Clinical Practice Training. Site or trial site: The location(s) where trial-related activities are actually conducted (ICH E6, 1.59). All source documents should also be retained for the entire record retention period even if a subject has withdrawn from the clinical trial. The sponsor did not keep complete and accurate records to show the clinical trial was conducted in keeping with. These standards provide guidance on all aspects of clinical trial conduct, from study design to data analysis and reporting. There are a number of requirements for obtaining ICH GCP certification, including: The impact assessment of this change may require submission of an amendment request to Health Canada instead of a notification. - Possess a high school diploma or equivalent based on an assessment of the application or any information or drug samples submitted as additional information Health Canada has reasonable grounds to believe that either: the use of the drug for the purpose of the clinical trial endangers the health of a clinical trial subject or other person, the clinical trial is contrary to the best interests of a clinical trial subject; or. Other requirements may apply to the transfer, storage and destruction of records, including: It is considered acceptable, for example, to scan documents in an electronic format and store them on specific software or networks as well as on other devices such as flash drives (e.g. A certified copy is a copy (irrespective of the media used) of the original record that has been verified (e.g. 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. It typically takes a few days to become ICH GCP certified, depending on your level of experience and learning speed. This period of time will allow for subject follow-up throughout the subsequent stages of drug development, assessment, marketing, as well as provide the ability to assess the impact on the next generation. (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial; (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. 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. As per section C.01.001 of the Regulations, an expiration date is defined as: During an inspection, Health Canada may verify that the clinical trial drug has a valid expiration date. Further expanded on in section 1.2 of ICH E6, the definition of "adverse event" reads: "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. This practice is also recommended by Health Canada, although alternative verification methods, consistent with the principles of ICH E6, may also be acceptable (e.g. The sponsor did not get written inform consent for every person before they participated in the clinical trial or the amended clinical trial. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki. 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 sponsor should define and identify the protocol deviations to be reported. 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. 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 (. Definitions quoted from other documents are identified in brackets at the end of the definition. Sponsors may also be required to maintain records under provincial law, institutional policies, and contractual agreements with QIs, REBs or others. Therefore, adequate documented assessment and approval of changes to hardware or software during the course of the clinical trial are required. The sponsor of a clinical trial is ultimately responsible for maintaining all records for the required record retention period. (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows: (a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and. Organizations LEARN MORE Learners EXPLORE COURSES Questions? The clinical trial was not conducted according to protocol. 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.". The qualified investigator (QI) is the person who is responsible to the sponsor for the conduct of the trial-related activities at a site (see QI definition in Appendix A). Note: Observations pertaining to "computerized system validation" are usually cited under paragraph C.05.010(c) of the Regulations. Records created, maintained and processed by outsourced systems (i.e. When tasks are delegated to a person in charge of other staff (e.g. Proper rationale and justification should be used. 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). ICH GCP certification is a credential that demonstrates you have met the set of global standards for the ethical conduct of clinical trials. Drug: means a drug for human use that is to be tested in a clinical trial. The International Conference on Harmonisation (ICH) has developed a number of global standards for the ethical conduct of clinical trials, collectively known as Good Clinical Practice (GCP). Please note that the ICH website is only available in English. the specific reports encountered in GLP, GMP, QA/QC, and GCP. (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. 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. 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