8.13.1 Submit Documents for WCG IRB Review

This section outlines the process for submitting protocol / site documents for approval using the WCG IRB tab within a study.

Warning: Submissions must follow all requirements for WCG IRBs, which includes downloading the necessary “Smart Forms” from the WCG IRB website and including those in the submission. Failure to submit the necessary documents will result in delays in IRB review of the submission.

To submit a document to the WCG IRB for review:

1. Navigate to the Attachments tab of the target study and ensure that the documents intended for submission have been added and placed in the Freeze status.

2. Click on the WCG IRB tab.

The WCG IRB page loads. A message stating, “No IRB submissions have been made for this study” will display if no submissions have been made.

- OR -

If previous submissions have been made, the submissions will display on the left side of the screen:

3. Click the Create New Submission button on the right side of the screen.

The Create New Submissions window displays:

4. Provide the submission details by completing the “Name”, “Submission Group Type”, “Submission Type”, and “Notes fields”. The Principal Investigator field is auto-populated based on the information entered into the Study Summary / Study Details tab.

The following table displays each Submission Group Type and the Submission Types available within each:

Submission Group Type	Available Submission Type
New Study	Initial Review
New PI Submission	Initial Review
Existing Site Submission	Change in Research
	Change in Investigator
	Closure Report
	Contact Information Update
	Continuing Review Report Form
	DSMB and New Scientific Evaluations
	Dear Investigator Letter
	Drug Brochure
	FDA Inspection Information or Medical Board Action
	HUD Submission
	IND Safety Report
	Promptly Reportable Information
	Protocol Amendment or Clarification
	Recruitment or Supplemental Documents
	Translations
	Other Materials
Existing Study Submission	Change in Research
	Consent Form
	Contact Information Update
	Continuing Review Report Form
	DSMB and New Scientific Evaluations
Existing Study Submission	Dear Investigator Letter
	Drug Brochure
	HUD Submission
	IND Safety Report
	Promptly Reportable Information
	Protocol Amendment or Clarification
	Recruitment or Supplemental Documents
	Translations
	Other Materials

5. After the applicable information has been entered, click the Step 2: Select Document button to continue.

- OR –

Click the Save as Draft button to save this submission as a draft that you can return to later to complete.

Note: If you click Save as Draft in step 5 above, the Create New Submission window will close, and you may restart this process at step 4 by clicking on the draft submission in the WCG IRB tab.

6. After clicking the Step 2: Select Document button, the document selection screen displays:

Note: Documents must first be added to the Versions/Study Documents tab and placed in the Freeze status to be available for submission using the WCG IRB tab.

Warning: Submissions must follow all requirements for WCG IRBs, which includes downloading the necessary “Smart Forms” from the WCG IRB website and including those in the submission. Failure to submit the necessary documents will result in delays in IRB review of the submission.

7. Click the checkbox next to each available document that you would like to include in this submission. For each document you select, an information card will display on the right that corresponds to that document.

8. To remove documents from the submission, click the “X” button in the upper-right corner of the document information card in the Documents to include in Submission section.

9. After selecting the required documents, click the Submit to WCG IRB button to submit these documents for IRB review.

- OR –

Click the Save as Draft button to save this submission as a draft that you can return to later to complete.

Note: If you click Save as Draft in step 9 above, the Create New Submission window will close, and you may restart this process at step 7 by clicking on the draft submission in the WCG IRB tab.

After finalizing the submission for IRB review, the new submission displays in an information card on the left side of the WCG IRB tab.

Warning: There is a short delay after you finalize your submission before it is received by the IRB. While your submission is awaiting transmission to the IRB database, a status of “Unsubmitted” will display. Once transmission has been completed, this status will change to “Transmitted”.

Note: For more information on submission statuses and the information cards displayed on this page, see the Review Submissions section.