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Clinical Trials Resource Group

Clinical Trials Resource Group

Activity 5. Submit to IRB and Obtain IRB Approval

5.1 5.2 5.3
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Activity 5. Submit to IRB and Obtain IRB Approval

5.1   Submit Required Documents to IRB

At the time of this publication, the IRB Administration accepts electronic submissions through the eDocs system, which is accessible at http://research.ucdavis.edu/edocs

The IRB plans to convert the submissions to the new electronic platform, called Kuali Coeus. Please follow the instructions as they become available on the IRB website.

5.1.1      Submitting your materials to the IRB via E-Docs

The IRB requests that each document is submitted as a separate file in order to facilitate administrative processing. Use “PDF Portfolio packaging” of the submission so that each document remains as a separate file within the package. Submissions incorporating multiple documents as a single PDF or Word document will be returned for splitting into separate documents. Missing documents can cause delays in the review and approval of your submission. If you have more than one consent form, advertisement, survey, etc., include a one to two word identifier in the footer of the document to easily distinguish the documents of the same type from each other. Document files should be named such that they are easily identifiable.

                  i.    Go to http://research.ucdavis.edu/edocs

                 ii.    Click on “eDOCS Page”

                iii.    Click on “Drop off your documents”

               iv.    Enter your information in the “From:” section. [The IRB highly recommends that you utilize the drop down “Notify me of receipt”, to be informed when the document is picked up by IRB Administration staff]

                v.    Determine which IRB mailbox you wish drop off the documents utilizing the following descriptions:

  • IRB Applications: use when submitting new, continuing review, modifications, closure requests, and administrative approvals
  • IRB New Reportable Information: only use when submitting form HRP-214 “Reportable New Information

               vi.    Highlight by clicking once on the desired mailbox and then click “Add >>”

              vii.    Click the “Choose File” button to browse your computer for the file you want to send. Select file, then click “Open”

             viii.    Repeat step 7 to attach all files for a complete submission. The complete package of materials must be submitted all together through eDocs. Do not transmit one document at a time or piecemeal documents as they will not be accepted and will be deleted

               ix.    Click “Send” to notify IRB Administration that the files are ready to be picked up through the eDocs system

                x.    For questions or problems, please contact IRBadmin@ucdmc.ucdavis.edu

If you inadvertently submitted an incomplete package of materials, please immediately email IRBadmin@ucdmc.ucdavis.edu.

This information can be found online at http://research.ucdavis.edu/pgc/d/irb/eDocsSubmission05.16.129.pdf

http://research.ucdavis.edu/edocs

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5.2 Respond to IRB Comments and Obtain IRB Approval

The IRB will provide you with a written decision indicating that the IRB has approved the Human Research, or requires modifications to secure approval, or has disapproved the Human Research.

  • If the IRB has approved the Human Research: The Human Research may commence once all other organizational approvals have been met. IRB approval is usually valid for a specific period of time and has an expiration date which is noted in the approval letter.
  • If the IRB requires modifications to secure approval and you accept the modifications: Make the requested modifications and submit them to the IRB. If all requested modifications are made, the IRB will issue a final approval. Research cannot commence until this final approval is received. If you do not accept the modifications, write up your response and submit it to the IRB (refer to HRP-213).
  • If the IRB defers the Human Research: The IRB will provide a statement of the reasons for deferral and suggestions to make the study approvable, and give you an opportunity to respond in writing. In most cases if the IRB’s reasons for the deferral are addressed in a modification, the Human Research can be approved
  • If the IRB disapproves the Human Research: The IRB will provide a statement of the reasons for disapproval and give you an opportunity to respond in writing.

In all cases, you have the right to address your concerns to the IRB directly at an IRB meeting.

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5.3   File Approvals into Regulatory Study Binder

Please reference Activity #11.8 for documentation maintenance.

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