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.