The G-HlthProdImprtExptReqs further states that all blood samples as well as cultures, diagnostic specimens, or research tissue are considered to be potential carriers of human or animal pathogens, and are regulated by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA). K1A 0K9, Phone (General Enquiries): 613-957-0368 The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, requires clinical trial researchers to include a plan for monitoring safety, efficacy/effectiveness (where feasible), and validity in their proposal for EC review. As mentioned earlier, only CIHR-, NSERC-, and SSHRC-funded institutions are required to comply with this guidance as a condition of funding. The Investigators Brochure (IB) is a multifunctional regulatory document essential for the conduct of clinical trials that summarises the physical, chemical, If the Directorate finds the application complete, an acknowledgement letter is issued to indicate the 30-day default review period commenced on the date of receipt. The communication of this information should be documented. For a SM relating solely to Part II, only the mandatory Part II documents must be supplied. Although not specified as a sponsor requirement, the CA-ICH-GCPs states that a Data and Safety Monitoring Board (DSMB) (known as an Independent Data-Monitoring Committee in Canada) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. For HCs interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. The attestation should not be submitted to HC unless requested. Individual SAEs are not reported in CTIS. This evidence of validation should be kept for the required record retention period and available for inspection by Health Canada (HC) inspectors. In addition, the sponsor must ensure that: The CanadaFDR and the G-CanadaCTApps, require the sponsor to complete and retain the Research Ethics Board (REB) Attestation (CAN-8) and Qualified Investigator Undertaking (QIU) (CAN-37) forms at each trial site, while submitting in electronic format the Clinical Trial Site Information Form (CAN-6) to the appropriate HC Directorate for each trial site. In addition, sponsors may make the following changes immediately if it notifies HC in writing within 15 days after the date of the change: a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug; or a change to the protocol that does not alter the risk to the health of a participant. Per CAN-8, an attestation must be completed by the EC that reviewed and approved the clinical trial. , which sets the ethical benchmark for all Canadian institutional ethics committees (ECs), states that where researchers seek to collect, use, share, and access different types of information or data about participants, they should determine whether the information or data proposed in research may reasonably be expected to identify an individual. endobj unblinding. As per CAN-29, HC is one (1) of five (5) federal agencies within Canadas Health Portfolio overseen by the Minister of Health. The outer label should be clearly identified with "Clinical Trial Application." Financial disclosure forms Rather than an age-based approach to consent, researchers should use an approach based on decision-making capacity in compliance with any laws governing research participation. General Enquiries E-mail: [email protected]. for pharmaceutical drugs. Upon completion of the trial, as delineated in CA-ICH-GCPs, the investigator is required to submit a final report to the institutional EC summarizing the trials outcome. For additional details, please clickhere. ): Per CAN-35, if blood is taken, indicate total volume (e.g., teaspoons and milliliter equivalent) and note the possibility of bruising or swelling while giving blood, or other possible discomforts at the site where blood is drawn. A sponsor who is not based in Canada must have a Canadian representative who is responsible for the import of the IP and demonstrates compliance with the applicable regulatory requirements. In addition, if a sponsor (Canadian or foreign) wants to import a drug into Canada to conduct a clinical trial, a copy of HCs clinical trial authorization (i.e., the NOL) must be included with the drug shipment. Remember: It is the principal investigators (PIs) responsibility to ensure study-related activities have been delegated appropriately. The redacted version is made public in the public part of CTIS. The REB letter does not need to include all the elements contained in PART 1, PART 2 and PART 3 of the Health Canada REB Attestation Form. Risk Group 1 consists of microorganisms, nucleic acids, or proteins that are unable or unlikely to cause human or animal disease so they are generally not considered to be pathogens, and are therefore exempt from the HPTA and the HPTR licensing requirements. The annual safety report (ASR/DSUR) must be submitted in CTIS. In addition, the obligation to report all SUSARs to the MREC remains. Address Locator: 3105A ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed vulnerable. <>>> Analysis of a recent article in PLoS One, The needs assessment in continuing medical education, Origin and development of English for Medical Purposes. Per CAN-35, ICFs should be translated where it is relevant to particular communities. Documents that legally require signatures may be signed with an electronic signature, or the signature page can be printed, signed, scanned, and saved as a PDF file. In order to continue the clinical trial after this date, the clinical trial has to be switched to the CTR. Health Canada If documentation is incomplete, sites run the risk of regulatory inspection findings such as a Form FDA 483. Note that a sponsor does not have to submit a CTA for authorization to import an IP used in a Phase IV clinical trial. WebTransformations Investigator brochure - - yourcrosspointnv Transformations student investigator application a type a quote from the document or the summary of an interesting point. It is also important to recognize that in some cultures written consent is not consistent with community traditions. Platform for Sponsors, Sites, Participants. Importantly, when authorization for participation was granted by the participants legal representative(s) or guardian(s) and a participant acquires or regains decision-making capacity during the course of the research, the researcher must promptly seek the participants consent as a condition of continuing participation. ), To document agreements between the PI/institution and the study sponsor and/or CRO. The investigator must report the SAE to the sponsor within 24 hours of it being discovered. See the Scope of Review section for detailed institutional EC requirements, and the Submission Content section for additional HC approval information. Article 10.2 of the G-TCPS2 further indicates that researchers can use a range of procedures to seek and document consent, including oral consent documented in field notes, and other forms of recording (e.g., a consent log, audio or video recordings, or other electronic means). Youth who have not reached the age of majority (either 18 or 19 depending on the province or territory) may still be old enough to provide their own consent. All participants (up to 20) are eligible for Certificates of Attendance, and accreditation, provided that accreditation The G-TCPS2 and the CA-ICH-GCPs state that the research participant and/or the legal representative(s) or guardian(s) should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or the participants rights. E.g., non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results. Althoughthe IB also serves other purposes, it is primarilywritten to enable investigators conducting clinicalstudies to assess the risks and benefits associatedwith an investigational product. Confidentiality Statement and Signature Page Recruitment arrangements: This document may be omitted if the recruitment of new trial participants has stopped. In addition, the CA-ICH-GCPs state that the IP must be coded and labeled in a manner that protects the blinding, if applicable. Is there a connection between CTIS and ClinTrial.gov? However, when justified, it may be performed at the investigational site by or under the supervision of the clinical trial site pharmacist, or other health care professional in accordance with national regulations and with the sponsors requirements. Per HCNotice-ICH-E17, HC announced the implementation of CAN-40, which describes general principles for the planning and design of multi-regional clinical trials with the aim of increasing the acceptability of these trials in global regulatory submissions. Per ElecSubms, applicants must submit CTAs electronically in either eCTD format or non-eCTD format. The G-FDR-0100, provides additional guidance on requirements if a sponsor plans to send the clinical trial IP(s) directly to each trial site: The G-CanadaCTApps, the G-HlthProdImprtExptReqs, the G-FDR-0100, and CAN-32 state that if a sponsor wants to import a drug into Canada for a clinical trial, a copy of HCs authorization (i.e., the No Objection Letter (NOL)) issued by either the Pharmaceutical Drugs Directorate (PDD) or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) must be included for the applicable trial with the shipment. For children who are not sufficiently mature to provide consent but are able to understand the nature of study participation, researchers must obtain the childs assent in addition to the consent of an authorized third party. WebThe investigators signature on this form constitutes the investigators affirmation that he or she is qualified to conduct the clinical investigation and constitutes the investigators For more details, see CAN-41. Whereas, the footer includes investigator's signature, date of signature, version number, and page number. WebInvestigator's Brochure (IB) To document that relevant and current scientific information about the investigational product has been provided to the investigator; Typically there is See CAN-35 for submission requirements to the joint HC-Public Health Agency of Canada (PHAC)'s REB. In accordance with the G-CanadaCTApps and CAN-22, the sponsor must submit annually to HC an updated IB, which serves as the annual report, including all safety information and global status. Limits to confidentiality and additional requirements for projects led by HC or the Public Health Agency of Canada (PHAC) are provided in CAN-35. In addition, researchers should develop a management plan for review by the EC. As set forth in the CanadaFDR and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. K1A 0K9, Phone: 613-863-8405 The CanadaFDR requires the sponsor to maintain all trial-related records for a period of 15 years. ADR reports that are expected or unexpected, but not serious, should not be reported to HC, but rather monitored and tracked by the sponsor. Click on the ' register ' link below. Only those members who participate in the EC review and discussion should vote, provide their opinion, or advise. This can include training on specimen collection, handling, and storage. Does the legal representative also have to be registered in OMS? The investigators signature on this form constitutes the investigators affirmation that he The sponsor should not supply the IP(s) until approvals from Health Canada (HC) and the institutional ethics committee (EC) are obtained. If the CTA is rejected, a Not Satisfactory Notice (NSN) is issued. It is generally preferable to give participants the opportunity to opt out of future use. The CanadaFDR states that the sponsor should maintain all trial-related records for a period of 15 years. The lead PI is responsible for communicating any changes to the study, new information, and/or unanticipated events to the EC, to the sponsor, and to local site PIs. See G-Storage for information regarding compliance with the CanadaFDA and the CanadaFDR, as it relates to packaging clinical trial drugs for human use, such as the role of environmental controls, quality risk management, and special considerations for active pharmaceutical ingredients. As part of its QA system, the CA-ICH-GCPs notes that the sponsor should ensure the trial is monitored and audited. Investigational product (IP) labeling in Canada must comply with the requirements set forth in the CanadaFDR, the G-CanadaCTApps, the G-GMP-Annex13, and the CA-ICH-GCPs. SUSARs must be submitted via Eudravigilance. For HCs interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. Key Concepts), Policies, Guidelines, and Resources; Consent Process (Key Considerations), Part C (Division 5 (C.05.005, C.05.006, C.05.008, and C.05.010)), Policies, Guidelines, and Resources, and Consent Process (Sample consent forms), Chapter 1 (Article 1.1), Chapter 2, and Chapter 3 (Articles 3.1 and 3.2), Part C (Division 5 (C.05.001 and C.05.005)), Chapter 3 (Article 3.9) and Chapter 4 (Article 4.7), Chapter 3 (Article 3.10) and Chapter 4 (Article 4.4), Chapter 4 (Article 4.3) and Chapter 12 (Articles 12.6-12.9), Chapter 3 (Article 3.1) and Chapter 4 (Article 4.7), Section # Block D and Appendix 1 Guidance, Importers Role, Table 1, and Human Drugs, Part C (Division 5 (C.05.001, C.05.005, and C.05.012)), Part C (Divisions 2 (C.02.006, C.02.011, C.02.015-016) and 5 (C.05.011)), Part C (Division 5 (C.05.001, C.05.005, C.05.010, and C.05.012)), Blood and blood components for transfusion, Purpose of the Act, Interpretation and Application, Obligation, Prohibitions, and Licenses, Health Products and Food Branch, Health Canada, Panel on Research Ethics, Government of Canada, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Canadian Institutes of Health Research, Government of Canada; Centre of Genomics and Policy, McGill University; and Maternal Infant Child and Youth Research Network, University of Calgary, Research Services, Calgary, Canada, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Canadian Clinical Trials Coordinating Centre, Council for International Organizations of Medical Sciences, This message was reviewed on June 23, 2023, OMB Control #0925-0668; Expiration date: 07/31/2025, Biologic and Radiopharmaceutical Drugs Directorate, Drugs not authorized for sale in Canada in development and in comparative bioavailability studies, Marketed drugs where the proposed use of the drug for one (1) of the following is different: indication(s) and clinical use; target patient populations(s); route(s) of administration; or dosage regimen(s). Per CAN-17, the following is the contact information for biologic clinical trials: Biologic and Radiopharmaceutical Drugs Directorate Clinical Telephone: 613-941-5199 Record of IB Health Products and Food Branch This additional label should state the new expiration date and repeat the batch number. The Q&A CTR questions 11.5, 11.6, and 11.7 describe the documents needed to transition a clinical trial approved under the Clinical Trial Directive (CTD). As per the CanadaFDR and the CA-ICH-GCPs, HC must approve a clinical trial application (CTA) and an institutional EC(s) must give ethical clearance prior to a sponsor initiating a clinical trial. for each Canadian site conducting the clinical trial are submitted to HC for Phase I-III trials, prior to the start of the study. Per the CanadaFDR, an application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial must be submitted to HC, signed and dated by the sponsors senior medical or scientific officer in Canada and senior executive officer. procedures. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial. According to HC-ICH-E2A (which Canada adopted pursuant to the HCNotice-E2A), at a minimum, the report should include an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. See the G-FDR-0100 for additional HC interpretations of the relevant provisions of the CanadaFDR. Refer to the G-TCPS2 for more detailed information on these categories. Pharmaceutical Drugs Directorate It is important that PDF files be properly bookmarked and hyperlinked. CTA-As must be authorized by HC prior to implementation of the changes. The information on this page is current as of Jun 07, 2023. Per CAN-35, adults with diminished decision-making capacity include: Per CAN-35, as is the case for any vulnerable population, care must be taken to ensure that adults with diminished decision-making capacity are not inappropriately included in research because of their situation, and neither should they be excluded from participating in research that may benefit them. The sponsor should ensure that the auditors are qualified by training and experience, and the auditors qualifications should be documented. A validated digital signature is accepted for this document. In some countries, these should also be signed by the sub-investigators as required by local regulations. Investigational New Drug (IND) safety reports. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants or cause them to overlook important facts and risks. It documents all relevant information about the Investigational Medicinal Product (IMP), including chemical structure, non-clinical trials and clinical trials. (See the Submission Content section for additional information on clinical trial application requirements). Does every affiliate have to be registered in OMS, or just the (main) sponsor location? The delegation log is one of the most common sources of issues during an audit. A Signature Page for acceptance of both the responsibility for confidentiality and for the IB. Address Locator: 0601C Will the ABR and EudraCT Form disappear for clinical trials after 31 January 2022? The protocol defines the type of SAE that does not require immediate notification. These documents serve to demonstrate the compliance of the investigator, sponsorand monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.. The risk of product mix up must be minimized by using appropriate procedures, specialized equipment, and relevant staff training. The sponsor should use the Clinical Trial Site Information Form (CAN-6) to submit the required information. As set forth in the CanadaFDR, the G-FDR-0100, and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. Ensure this documentation is complete (e.g., for protocol; investigators brochure [IB]; consent documents, questionnaires, diaries, and other participant-facing documentation, etc.). Other questions about a CTR submission for the Netherlands can be mailed to: [email protected]. Per the Non-eCTDformat, CTA submissions to the appropriate Directorate within HCs HPFB must be in one (1) of these accepted media formats: All media should be labelled and contain the following information: Subsequent to burning the CD/DVD or transferring data to a drive, applicants should ensure that all files can be opened, files are not corrupted, and that "Thumb.db" files are removed. Per the CanadaFDR and the G-CanadaCTApps, during a clinical trial, the sponsor is required to inform HC of any serious, unexpected ADR that has occurred inside or outside Canada. Per G-TCPS2 and TCPS2-InterpCnsnt, where a child has some ability to understand the significance of the research, the researcher must ascertain the wishes of that individual with respect to participation. Per CAN-35, because the G-TCPS2 does not specify an age of consent for children, the decision on whether to seek consent from children is based on whether they have the capacity to understand the research and the risks and benefits of their participation. Refer to the CA-ICH-GCPs for detailed sponsor-related IP requirements. All pediatric participants, however, should be informed to the extent compatible with the childs understanding, and if capable, the pediatric participant should sign and personally date the ICF.
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