Clinical trials are critical in the investigation of a drug or natural health product (NHP) for use in humans
Clinical trials help discover or verify pharmacological (properties of a product) or pharmacodynamic (medicinal effects of a product) attributes, assess safety or efficacy, and identify adverse events. At Apex Trials we follow best practices ensure compliance with regulations and to ensure the protection of the rights, safety, and well-being of out valued clinical trial participants.
Research Ethics Board
Research Ethics Board (REB) have an important role in the oversight of clinical trial conduct to review all research that involves humans to ensure that it meets the highest ethical standards and that the greatest protection is provided to research participants. Before a study launches at Apex Trials, our team ensures REB approval has been granted and any other regulatory requirements or authorizations have been met prior to commencing any study activities.
ICH and GCP Regulations
Health Canada's Clinical trial regulations are generally consistent with the principles, definitions and standards found in the International Conference on Harmonization (ICH) Guidance documents on clinical trials including the generally accepted principles of good clinical practice (GCP).
Health Canada's Role in Clinical Research
For Phase I through Phase III clinical trials on drugs and natural health products, Health Canada must review and permit a clinical trial to begin. Health Canada may also visit companies involved in research to inspect them and ensure the study is being conducted as permitted by Health Canada.
At Apex Trials we follow the standards set forth for the Personal Information Protection and Electronic Documents Act (PIPEDA) as well as the Personal Health Information Protection Act (PHIPA) which establish rules for the collection, use and disclosure of personal health information.
Your information collected at Apex Trials will be kept confidential to the extent permitted by law. Information about you that will be physically or electronically collected during a study will be stored with restricted access. Any information collected about you will be identified by codes or numbers instead of your name and samples labeled with codes or numbers when sent to a lab for analysis. Only the study staff will know your identification number or code, and this information is stored securely. You will not be identified in any publication that results from a study.
Unless required by law, your information will only be accessible at Apex Trials to study investigators and researchers, delegated study staff at Apex Trials, the Sponsor of the study, the Research Ethics Board, and the government regulatory agency (for example, Health Canada). Disclosures required by law may require a researcher to report information to the appropriate authorities.
An audit/inspection may be conducted by any of the groups listed above in order to ensure the accuracy of study records, compliance to the study protocol, applicable regulations and guidelines, and to ensure participant safety oversight. Study records are securely stored by Apex Trials and upon completion of the study are maintained per the local clinical trial regulations (e.g., 15 years for Health Canada requirements).
Study staff make every effort to protect the privacy of your information. However, absolute confidentiality cannot be guaranteed.