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Update August 6, 2011
August 6, 2011
As part of quarterly scheduled updates, the following changes have been made in eIRB:
- “Create Clone” Activity – For eIRB applications approved prior to August 6th 2011, a “Create Clone” activity must be performed in order to create a new Change in Research Application. This is a one-time only process and does not have to be completed for subsequent FSAs. The PI/study team member must do the following:
- You will see the following message under “Create FSA”: If you are creating a Change in Research, you must first select “Create Clone” above to create a working copy of the application.
- The PI/study team must run the “Create Clone” activity prior to creating a Change in Research Application.
- A clone/copy of the application will be created in the background. The cloning process will take 10-30 minutes.
- The PI and the study team member who initiated the clone activity will receive an email notification upon completion of the cloning process.
- Study Team Member Affiliation picker – The PI/study team will now have the option to select an affiliation for study team members (Section 1 – General Information, Q. 13.0, sub question 3.0).
- Continuing Review Application, Section 5 (Q. 3.0) – Revised question as follows:
- Old: If this is a clinical trial, Please provide the Clinical Trial Registration number and registration site (if not previously included in the eIRB application), or explain why this trial does not require registration under the JHUSOM Clinical Trial Registration policy.
- New: “Is this a clinical trial?” If the answer is “no”, you may continue to the next page. If the answer is “yes”, the following required text field will appear:
- If the Clinical Trial registration number has not been listed in the eIRB application, provide the registration number and registration site, or explain why this trial does not require registration under the JHUSOM Clinical Trial Registration policy. If the registration number is already listed in the eIRB application, state "In eIRB application".