If you are completing the protocol for the first time and it has no previously approved word document version, you should mark “no” to this question. A “modification” is a change made to the protocol only after the protocol is approved. If the pre-reviewer or the Board request revisions to the protocol during the review process, this is not considered a modification. Modifications can be submitted at any time; the review process depends on the level of changes that are made to the protocol. Some minor changes can be approved administratively but if the modification alters the scope of the project and/or increases the level of risk, the protocol may need to be reviewed by the full board.
In this section of the protocol form, you will describe the changes that you made to the protocol. Please note that our program is able to detect and highlight changes that are made between versions (up to three versions). The reviewers will be able to see changes made directly in the text which will help them to quickly assess what changes have been made. In addition, the questions in this section will help to highlight underlying reasons for making changes.
If you are completing the protocol for the first time and it has no previously approved word document version, you should mark “no” to this question. If you made changes to the previously approved protocol, even minor changes, you should mark this question as yes.
If you select “yes” you need to go to the Risk and Benefits section and update your response to address additional risks and/or new information about risks to participants in this study.
As previously stated, the program is able to detect changes made in the text boxes so it is not necessary to report every edit. Use this box to provide an overall summary of the changes and the rationale for making the changes. Make sure that the content in this section applies to the modification you are currently making (i.e. don't describe previous modifications or provide information that isn't relevant to this change) and make sure that everything in the protocol accurately reflects the plan that you anticipate putting into place once the protocol is approved.