Changes During Study Conduct (Modifications)

Once the IRB has approved a project, it must be carried out as planned. Any modifications must be approved by the IRB prior to implementation. Modifications encompass any change from correction of typographical errors, updating phone numbers, and change of study personnel to changes in patient recruitment methods, protocol procedures, design and analysis.

Materials to be used for subject recruitment that were not included in a study's initial review are also considered modifications.

Board approval for modifications to research and informed consent documents may be requested at any time using the Modification Request and other associated forms.

 

When submitting the applicant must provide copies of all new study documents or those that change with the modification, e.g., recruitment materials, FDA Form 1572, additional CVs, informed consent form, etc.