The following sections of the application have changed:
- The first page now includes a text box explaining that all questions with red asterisks are required.
- Question 8-3.6 (Subject Recruitment) regarding requirements for IRB number on recruitment materials includes new clarifying text.
- A new question, 16.2.24 (FDA Approved Device), allows investigators to upload supporting documents.
- Question 29.4 (Survey Detail) now alerts those using electronic survey instruments of special instructions for informed consent documents.
- Question 32-1.2 (Data and Safety Monitoring Plan) includes an updated link to IRBMED adverse event reporting requirements.
Scheduled Continuing Review (SCR)
- The Jump To tool in the top navigation bar of the SCR form has been updated. The new functionality displays only the pages required to complete the renewal application, rather than all possible pages. It also differs slightly in appearance from the Jump To tool in the initial application or amendment form.
- Section 2-2 (Subject Enrollment Status) includes a new question, 2-2.1.1. This allows study teams to explain any discrepancies between projected and actual enrollment numbers.
The title field on the amendment cover sheet now indicates that there is a 255 character limit.
Withdraw Activity for Amendment and SCR
The Withdraw activity for amendments and SCRs now clarifies that the amendment or SCR (and not the parent study) is being withdrawn.
Improved validation has been added to the following sections of the application. The system requires users to enter data in fields based on previous answers in the application. Applications submitted following this update, and applications returned for contingencies or questions following this update will be subject to these new validation rules.
- 3-2.2, 3-2.3
- 32-2.1, 32-2.2, and 32-2.3
- C1.2 (Conflict of Interest)
Online Help Changes
The following sections of the online help have been updated:
- Section 8-1.2 (Estimated Number of Consented Subjects) now includes instructions for longitudinal studies.
- The GCRC budget now includes information about and a link to the Michigan Diabetes Research and Training Center (MDRTC) application.
- Section 1.10 (Estimated Dates) now clarifies that these dates refer to estimated length of the entire study, and not to the actual start and end dates.