8.1. Anticipated Study Timeline
• Recruitment Initiation — D0
• 20 Subjects Recruited — D0 + 4 weeks
• Interim Analysis Completed — D0 + 4 weeks +10 days
• Study Complete — D0 + 6 weeks
8.2. Criteria for the Termination of the Trial
The study will be terminated upon completion of the recruitment target (N=20) and verification of the data by the study sponsor. The study may also be terminated earlier at the discretion of the sponsor.
8.3. Essential Documentation
The Principal Investigator and other appropriate study personnel will sign the protocol to document their willingness to adhere to this protocol and to conduct the study in accordance with local legal requirements and the International Conference on Harmonization (ICH) guidelines for GCP.
In order to be authorized to initiate the study, the Principal Investigator will ensure the following documentation is obtained:
1. A copy of the dated, documented approval of the IRB to the protocol and any amendments, subject consent forms, advertisements for subject recruitment , subject compensation, and any other documents submitted. The IRB approval should quote version numbers and/or dates of documents reviewed
2. Evidence that the IRB operated in compliance with 21CFR56 (e.g., list of members and affiliations)
3. The Principal Investigator’s current curriculum vitae (CV)
4. A copy of the protocol signed with a statement of interest by the Principal Investigator
All other relevant documents essential prior to study initiation should be placed appropriately in the site’s study master files.
8.4. Subject Confidentiality
The confidentiality of subjects enrolled in this study will be maintained at all times.
All study reports and communications relating to subjects will identify each subject by their subject number and initials only. Investigators will maintain a log enabling them to identify clearly each subject enrolled.
8.5. Quality Control, Quality Assurance, Monitoring
The data from source documents will be entered into CRFs. The data will be subjected to manual review for completeness, logic, accuracy, and consistency. A final monitoring report will be generated demonstrating compliance to the protocol.
8.6. Data Integrity
Data integrity is ensured through monitoring by the sponsor of source document to CRF verification.
8.7. Data Handling and Record Keeping
8.8.1. Study Finance
Subjects will be provided $100 CAD as compensation for their involvement at the end of the second study visit, following the completion of all study procedures.
8.8.2. Financial Disclosure/u>
The investigator must provide the sponsor with sufficient and accurate financial information to meet regulatory disclosure requirements (21 CFR 54). The investigator will update this information if any relevant changes occur during the investigation and for one year following the completion of the study.
8.9. Publication Policy
All information concerning the sponsor’s operations, such as patent applications, formulae, manufacturing, processes, scientific data, or information supplied to the investigator by the sponsor and not previously published is considered confidential and shall remain the sole property of the sponsor. The investigator agrees to use this information only in accomplishing the study and will not use it for other purposes, without the prior written consent of the sponsor.