eIRB Updates

 

QA Completeness Clarifications

The IRB has observed some confusion and misinformation around eIRB application completeness. We want to clarify a number of things:

  1. Applications for migrated protocols are considered to be current and approved. eIRB Completeness is considered a QA activity. For that reason, the IRB is extending flexibility.
    • The IRB is asking for this QA to be completed, ideally within 1 calendar year to coincide with the timeframe that HSERA will remain view only.
    • Completeness does NOT have to be done before required regulatory submissions, or submissions from your Sponsors. Completeness does NOT have to be done before submission of new studies.
    • It was recommended completeness be paired with a planned amendment to spread out this work.
    • IRB staff are looking at completeness. If you cannot do completeness with an upcoming study amendment, please indicate so in your cover letter.
  2. Active paper protocol records were migrated to eIRB and therefore have an existing eIRB record.
    • If you cannot locate one of these records, you may not be listed in the research team panel. Please contact the IRB help desk at e-irb@pobox.upenn.edu if you need access or need to locate such a record.
    • It is NOT necessary to create a new eIRB record for these paper protocols, unless you are specifically instructed to do so by the IRB. Completeness should be done in the original migrated record.
  3. Research with Drugs:
    • The IRB is aware of the difficulty of searching FDA drugs and there is a ticket in to improve this.
    • If you are adding a new drug manually, the only required fields are 1) drug name, 2) manufacturer, and 3) marketing status. IRB prefers that you do NOT enter dosages and route of administration so that one drug listing can be used for multiple protocols.
  4. As a reminder, validations are turned off for migrated studies – HSERA legacy protocols are only required to complete critical fields, not every field within the application as outlined in this guidance.

 

Document Upload Lag

It has been reported by some users that there is a lag /delay and system failure when uploading multiple documents at once or documents that have a larger file size. If you experience this issue – please directly report it to the help desk at e-irb@pobox.upenn.edu so that it can be investigated. Please provide information such as where you are working (e.g., on site or at home), how many documents you were trying to upload, file size range, how long it took the system to respond, and was the upload successful or failed.

 

Amendment Form

The summary of changes document upload field has been changed to not required to facilitate submissions.

 

Resolved eIRB Issues

Click here for a list of system issues and bugs that have been responded to. The IRB office and the vendor continue to work on outstanding issues, and this page will be updated periodically.