Should I close my study before January 4th, 2019?

To avoid unnecessary transition of studies to IRBNet, it is a good idea to take a look and see if they can be closed. Below are the criteria for making this assessment:

A final report can be submitted if all of the following criteria have been met.

  • Enrollment is closed
  • Participants have completed all research-related interventions
  • Data collection is complete
  • Data analysis of identifiable private information described in the protocol has been completed

For multi-site studies: If data collection and analysis at KPNW are complete and you have no other responsibility in the research, the study may be closed at KPNW even if it is continuing elsewhere. However, if you are the prime awardee for the study, the study must be kept open until all four criteria above have been met at all engaged sites.

If you receive inquiries on manuscripts and want to review the data, it is acceptable to look at raw data after a study is closed only to answer a question. However, you cannot perform additional analysis on that data unless it is de-identified (the identity of the subjects may not be readily ascertained by the investigator or associated with the information).

Naming Documents in the eIRB

In preparation for the migration to IRBNet, take the time with your upcoming modification submissions in the next few weeks to rename documents that do not follow the IRB naming convention. This will facilitate location of documents from migrated study data both in the new IRBNet system and in the Data Warehouse. It is not necessary to submit a modification solely for this purpose; you can simply include this step along with other items that need modifying before the final submission deadline on January 4, 2019. 

When you browse the computer to attach a document, the first field will show the file as it is named in your study’s file service, which you may retain. However, in the second field, rename the document so the first word in the title identifies what type of document it is. For example, an identifying first word would be Protocol, Consent, Recruitment, Survey, Investigator Brochure, etc. After the identifying word, use an underscore and follow it with any other words, dates, version numbers in any order. Document names must have more than 3 characters but should be kept somewhat short and should not contain spaces or special characters. 

External Site Contacts        

 In preparation for migration to IRBNet, please ensure institutions that collaborate with KPNW on a study are listed in the External Sites section of the eIRB. (Sponsors or facilities such as a central lab do not need to be listed.) When an external site is added to the eIRB, a small window will open asking for a contact name, phone number, and email address. Enter information for an IRB Administrator/Director/Manager employed at the external site for use by the KPNW IRB staff. Please do not use the External Site section to list contact information for a site PI or other external researcher. Instead, upload their contact information on a separate table to the Study Team Members section under #2 for other study staff.

The external site contact information window also has a place to mark “yes” or “no” indicating whether the external site will rely on the KPNW IRB or will review their own research. These questions are very important for IRB staff when processing a review.

To assist you in entering the appropriate IRB administrator’s contact information in the External Sites section, the Project Manager SharePoint site houses an External Collaborators list that can be amended as new contact information is discovered. (From the PM SharePoint main toolbar, click on “Document Type”, “Tools & Templates”, and then scroll to find “IRB External Collaborators Info for IRQ”.)

It is not necessary to submit a modification solely for this purpose; you can simply include this step along with other items that need modifying before we shut down the current system on January 4, 2019. 

IRB Announcements:

Breaking News!  IRBNet is Coming to KPNW

11/30/2018 – The National Compliance in Research Support Program (N-CRSP) at KFRI is leading a project to transition all eight regions to the IRBNet electronic platform with the hope of encouraging greater consistency and more effective collaboration across regional IRBs.  KPNW will adopt IRBNet in Q1 2019.

Read the Official Announcement