Introduction to eCTRC for PIs & Study Staff v

What is eCTRC?  eCTRC is a module within the eResearch Portal developed in collaboration with the IRB for easy electronic submissions to the Clinical and Translational Research Center (CTRC) at CHOP.  The eCTRC module is integrated with eIRB, utilizing “shared fields”. eCTRC module focuses on use of CTRC resources and does not duplicate info requested in the eIRB module.  PIs and Study Staff (SS) should follow eIRB instructions for navigating eIRB. eCTRC training guidelines assume you have received eIRB training.

Create a New CTRC Study All eCTRC new protocol submissions begin in eIRB. If you intend to use CTRC resources and complete a CTRC protocol submission, you MUST answer YES to question 3.0 in section 1.03 of the eIRB module. If you do not complete a joint IRB/CTRC e-submission, you will have to do an IRB amendment to initiate the CTRC request.

Complete the Study Application The CTRC is created as soon as you click save or continue on the page 1.03 of the IRB smartform. We recommend you complete the eIRB submission prior to the eCTRC submission. (If you choose to work between the 2 modules, you must select the PI and answer the conflict of interest question (Section #1.02 Question #1.0).

Where’s my eCTRC study? Complete your eIRB submission and click on Submit Study. Your eIRB and eCTRC submissions will be “linked” and identified with similar protocol numbers. You can get to the eCTRC submission from the eIRB module by clicking on this link and a new window will pop up.

Edit CTRC application Click on Edit CTRC study to complete the eCTRC application

Shared Fields: Locked Fill out the Smart Form pages. Questions with red asterisks are critical fields that must be completed. Many fields are “shared” with the eIRB module, but not identified as such. FYI…Once the eIRB protocol is submitted, all pages with shared fields will be “locked” in the eCTRC module. All changes to shared fields need to be initiated through the eIRB protocol. It is recommended to submit the eIRB protocol prior to completing the eCTRC study.

Complete application View of a shared field not yet completed vs. field already completed in eIRB

CTRC Utilization To itemize CTRC Utilization requests, click on the Add button and another window will pop up. Complete the Activity form for each utilization category listed, click OK or Add Another resource

CTRC Utilization The Smart Form will update with resource utilization request; use the “continue” button to move to next pages to detail your specific resource requests.

CTRC Utilization Tip: Use the Continue button to navigate through the application initially. Use the Jump to list when you know which sections are required for your study. Select the CTRC specific resources requested; hit “Continue” and complete the required information as it pops up

CTRC Utilization Example of Core Lab Resource request

CTRC Utilization Example of completed Collection and Processing Core resource request

Attach study documents Study documents attached in eIRB will be seen in eCTRC. There is another page available that you can upload CTRC specific additional documents if necessary.

Almost done! Hit FINISH

Submit study Hit SUBMIT STUDY to submit to CTRC. (Study staff are permitted to submit in eCTRC). Remember, if you haven’t completed and submitted the eIRB application, you still will have to do that. Only IRB approved studies will receive CTRC approval and resources.

Additional Notes As with eIRB, after you submit the CTRC study, check your CTRC work space for any correspondence about your protocol and the status of your study. eCTRC Continuing Reviews (CRs) and Amendments set up in similar fashion; future training to take place or on as needed basis. Contact Sharon Carbonara at X40578 or Ronnie Mazzaccaro at X42215 if you have questions.