Get the free Continuing Review Progress Report - dshs state tx

Continuing Review Progress Report Number Revision Date Page HRP-203 8/30/2013 1 of 1 Instructions Each section must be completed. If a section is not applicable to your submission state so Not Applicable and explain exactly why the section is not applicable.

How to fill out continuing review progress report

How to fill out Continuing Review Progress Report

1. Start by gathering all relevant information about the study, including the study title, principal investigator, and study ID.
2. Review the initial application and previous progress reports to ensure consistency in the data provided.
3. Provide an overview of the study's progress, including recruitment status, number of subjects enrolled, and any adverse events or protocol deviations.
4. Assess and summarize any changes to the study protocol since the last review.
5. Include an update on the data analysis performed and whether the study objectives are still on track.
6. Address any issues that arose during the reporting period and how they were handled.
7. Complete any required sections related to informed consent processes and ethical considerations.
8. Conclude with a summary of future plans for the study and any anticipated hurdles.

Who needs Continuing Review Progress Report?

1. Researchers conducting studies that require ethical oversight.
2. Institutional Review Boards (IRBs) that monitor compliance with regulations.
3. Funding agencies that may require progress updates for continued support.
4. Research institutions to maintain accountability and transparency of ongoing projects.

People Also Ask about

What is the common rule for continuing review?

A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the study's progress.

Do regulations require IRB to review ongoing studies?

Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects.

What is a continuing review in the IRB?

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.

What is IRB continuing review?

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.

What is the common rule for continuing review?

A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the study's progress.

What is a progress report in English?

A progress report is a report in which you are updating information about a project. Progress reports make it possible for management and clients to stay informed about a project and to change or adjust assignments, schedules, and budgets.

What are the three types of IRB review?

There are three major types of review: Exempt, Expedited, and Full.

What is the purpose of the IRB review?

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

For pdfFiller’s FAQs

What is Continuing Review Progress Report?

A Continuing Review Progress Report is a document submitted to an Institutional Review Board (IRB) or regulatory body to provide updates on the progress of ongoing research studies, ensuring that they continue to meet ethical standards and regulatory requirements.

Who is required to file Continuing Review Progress Report?

Principal Investigators (PIs) and research study teams are required to file Continuing Review Progress Reports for studies that involve human participants and are subject to oversight by an Institutional Review Board (IRB).

How to fill out Continuing Review Progress Report?

To fill out a Continuing Review Progress Report, researchers should gather relevant data about the study's progress, including recruitment updates, adverse events, changes to study protocols, and any other pertinent information as specified by the IRB. Each section of the report should be completed accurately and concisely.

What is the purpose of Continuing Review Progress Report?

The purpose of the Continuing Review Progress Report is to provide the IRB with an updated assessment of the research study's ongoing ethical compliance, to review participant safety, and to ensure that the study is still aligned with its originally approved protocol.

What information must be reported on Continuing Review Progress Report?

The information that must be reported typically includes enrollment numbers, any adverse events that have occurred, changes to the study protocol, participant demographics, and the status of the study with respect to its timeline and objectives.