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Continuation Request Form Sample Questions

The Continuation Request Form is similar to the Initial Protocol in that it is an interactive form with built-in logic. That means that the answers to some questions will reveal other questions. Only the questions that need to be answered for your specific research protocol will be visible to you. Please provide complete and detailed answers to every question that you see.

Below is a preview of the questions on the Continuation Request Form, organized by section of the form. Many of the conditional questions can be seen here, even if you may not see them when you are working on your submission.

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Project Details

Please choose the following from the drop down menus:

PI Last Name
Protocol Number "Protocol Title"

The combination of these two pieces of information will direct our system to autofill fields with project details, such as the PI's full name and department, the supervised researcher's full name and status (if there is a supervised researcher), and the funding status of the project, that you won't see on the form as you fill it out. These fields will appear on the resulting PDF that will be produced for your records and our review.

Subject Recruitment Status

The original protocol involved no data collection, only data analysis.
- How many subjects were originally approved for inclusion in this study?
- How many subjects are currently approved for inclusion in this study?
- How many subjects have been enrolled?
- How many subjects do you still plan to enroll?
- How many subjects have refused to participate at time of screening/informed consent?
- How many subjects have withdrawn from the study after informed consent was given?

Project Status

Project Activity Update

Since the last review period, have there been any complications, reactions, or adverse effects on human subjects?
- Please describe.
Since the last review period, have there been any changes in the literature that would affect this project?
- Please discuss.
Since the last review period, have there been any modifications made to your study protocol (without prior IRB approval)?
- Please describe.
Are you making any modifications to your protocol at this time?
- Please fill out a Modification Request Form.