Completing the Special Considerations and Procedures Page
How to complete the Special Procedures page
What is the purpose of the Special Considerations and Procedures page in the Study Summary Section?
The Special Considerations and Procedures page in the Study Summary section is an important branching page in the initial review smartform. Based on the responses provided on this page, study teams will be required to complete additional pages of the smartform relevant to each procedure checked. It is important to carefully consider which procedures apply to your study. If you select procedures that do not apply to your study, you will complete sections of the smartform unrelated to your study. If you do not select the procedures that do apply to your study, you will omit important information that is necessary for the IRB to complete its review. Choosing the procedures that best fit your study helps avoid unnecessary delays during the pre-review process.
When does the Special Considerations and Procedures page display?
The Special Considerations and Procedures page will display for full initial reviews, non-exempt medical record studies, most exemptions, and NCI CIRB facilitated reviews.
How do I know what Special Considerations and Procedures to select?
The best approach to completing this page is to broadly interpret the list of procedures and check all the procedures that may possibly apply to your study. NOTE: For the majority of studies, at least one of the special considerations or procedures will apply. Do NOT select the "none of the above" option until you have carefully reviewed all of the procedures listed.
What if I am not sure what procedures apply to my study?
If you are not sure whether a procedure applies to your study, it is generally best to check the option and then review the questions in that section of the form. To do this, follow these steps:
- Step 1: Select all the procedures you think may apply to your study.
- Step 2: Click the Continue button or the Save link.
- Step 3: Click on the Jump To menu in the blue bar at the top of the page. The relevant section(s) for the procedure(s) checked should appear in the drop-down menu.
- Step 4: Click on the link for the procedures section you would like to review.
What should I do if I selected the wrong procedures or missed selecting a procedure?
If you think you selected the wrong procedure or missed selecting a procedure that does apply to your study, use the Jump To menu in the blue bar at the top of any page in the smartform and click on Special Procedures. This will return you to the Special Considerations and Procedures page. You can then select or de-select any of the options listed. After you click the Continue button or the Save link, the smartform will update. Click again on the Jump To menu at the top of the page and the menu will display any new sections selected or will have removed any sections that were de-selected.