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This document is used to facilitate the continuing review process for research studies at the McGill University Health Centre, ensuring compliance with ethical standards and regulations.
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How to fill out APPLICATION FOR CONTINUING REVIEW

01
Obtain the APPLICATION FOR CONTINUING REVIEW form from the relevant authority or website.
02
Read the instructions provided with the application form carefully.
03
Fill out your personal information, including your name, contact details, and any identification numbers required.
04
Provide the necessary project or study information, including title, dates, and summary.
05
Include details of any changes in the research protocol or participant information since the last review.
06
Compile all required documentation, such as consent forms and data collection instruments.
07
Double-check all entries for accuracy and completeness.
08
Sign and date the application form where required.
09
Submit the completed application by the specified deadline, following any instructions for submission.

Who needs APPLICATION FOR CONTINUING REVIEW?

01
Researchers conducting ongoing studies that require ethical oversight.
02
Institutions that are responsible for ensuring compliance with ethical standards in research.
03
Participants who are part of studies that have undergone prior ethical reviews.
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People Also Ask about

Continuing Review is the process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review.
Continuing Review is a federally mandated re-evaluation of an approved study that is required to be conducted at least once per year. For most new non-exempt, minimal risk, and non-FDA regulated research projects, there will no longer be an expiration date and therefore, no requirement for annual continuing review.
Studies that qualify for an exemption do not undergo continuing review. Additionally, modifications do not need to be submitted for exempt studies so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found were applicable to the research.
There are three major types of review: Exempt, Expedited, and Full.
For research that is considered greater than minimal risk and for FDA-regulated research, continuing review will be conducted at intervals appropriate to the degree of risk, no less than once a year.
Once a study protocol has been approved by the IRB, there may be additional reviews required. These include reviews related to making changes to an approved study (regardless of review level), required annual renewal of approval, or secondary reviews based on study design, laws, regulations, or sponsors.
Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

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APPLICATION FOR CONTINUING REVIEW is a formal document that researchers submit to seek approval for the continuation of a previously approved research study, ensuring that the study continues to meet ethical and regulatory standards.
Researchers or institutions conducting studies that require ongoing oversight must file the APPLICATION FOR CONTINUING REVIEW to maintain compliance with institutional review boards (IRBs) and regulatory agencies.
To fill out an APPLICATION FOR CONTINUING REVIEW, researchers typically need to complete a standardized form provided by the review board, including details about study progress, participant enrollment, any adverse events, and updates on the study protocol.
The purpose of the APPLICATION FOR CONTINUING REVIEW is to ensure that a research study remains ethically sound and compliant with regulatory requirements, allowing researchers to continue their work without compromising participant safety or data integrity.
The APPLICATION FOR CONTINUING REVIEW must report information such as study progress, the number of participants enrolled, any adverse events or issues encountered, changes in the study protocol, and continued risk assessments.
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Research Ethics Board Continuing Review Human Subjects Research Clinical Trials Study Status Subject Reporting Informed Consent Safety Reporting Protocol Violations MHC Study Code

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