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01. Start with a blank Clinical trial protocol Canada Form
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02. Add and configure fillable fields
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Step 2: Go to the dashboard.

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Step 5: Insert text and titles.

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FDA Form 1572 for Canadian Sites FDA Form 1572 (Statement of Investigator) is a contract between the FDA and the clinical investigator. It states that the clinical investigator will: Conduct the study ing to the protocol. Personally conduct/supervise the study.
Clinical trials follow a plan known as a protocol. The protocol is carefully designed to balance the potential benefits and risks to participants, and answer specific research questions. A protocol describes the following: The goal of the study.
Developing a Protocol. GENERAL PROTOCOL CHECKLIST. Title. Protocol summary. Literature review/current state of knowledge about project topic. Justification for study. DESIGN. How study design or surveillance system addresses hypotheses and. VARIABLES/INTERVENTIONS. Variables. DATA HANDLING AND. ANALYSIS. HANDLING OF UNEXPECTED.
Background Information Name and description of the investigational product(s). A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects.
QUALIFIED INVESTIGATOR UNDERTAKING An undertaking must be completed by the qualified investigator responsible for the conduct of the clinical trial at the site specified below. The completed undertaking must be retained by the clinical trial sponsor for a period of 25 years.
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Related Q&A to Clinical trial protocol Canada Form

The medical writer then develops the complete CTP document, starting from the protocol synopsis. This includes review of the sponsor and study sites. Writing a complete CTP document takes at least six weeks for a simple early-phase study (first-in-human plus two weeks).
Include a detailed description of the primary and secondary objectives and the purpose of the study and clearly state your research hypothesis or your question. Discuss the projects feasibility. Give details of resources, skills and experience to complete the study. Include any pilot study information.
The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical

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