New Requests, Amendments & CRs

New Submission

To request service from CHPS, study teams must complete the eCHPS application within the CHOP eResearch protocol submission process.

All eCHPS new protocol submissions begin in eIRB. If you intend to use CHPS resources, you must answer “yes” to question 3.0 in section 1.03 of the eIRB module. For Cooperative Review studies, answer “yes” on question 4.0 in section 1.06. If you do not complete an initial joint IRB/CHPS e-submission, you will have to do an IRB amendment to initiate the CHPS request.

Selecting “yes” will open an eCHPS application that utilizes the IRB number for tracking purposes. Within the eCHPS workspace, you can edit the CHPS study to begin completing the eCHPS application. We ask that you fill out each of the pages. Questions with red asterisks are required. Many fields are shared from the eIRB module and will not need to be entered twice.

Once the eCHPS application is completed and submitted, the request will be reviewed by the Directors of the Cores being requested and our Resource Committee.

After you submit the CHPS study, check your eCHPS workspace for any correspondence and the status of your study. Studies must receive both IRB and CHPS approval before Core services can be utilized.

Amendment

To start a CHPS amendment, go to an Approved protocol’s workspace, at the bottom of the left-hand navigation bar, select “New Amendment”. Please complete the amendment form, then hit “FINISH”.

Once the eCHPS amendment form is finished, please select “Edit Modified Study” to make the specific changes to your study application and to update/change request for Core services. Once the eCHPS application has been updated, please submit the amendment for review. The request will be reviewed by the Directors of the Cores being requested and our Resource Committee.

Often a change in study design and/or services will also require an IRB amendment. Please check with the IRB to see if an amendment is needed.

An eCHPS amendment may also affect the study budget (e.g. additional services or visits). You can submit a budget amendment request in SIFTER so that a corresponding OnCore budget amendment can be initiated. If you have any questions regarding a budget amendment, please email CTFM [at] chop.edu.

Continuing Review

For studies approved by the CHOP IRB that have a specified expiration date, CRs are linked between IRB and CHPS. Follow the instructions from eIRB to start a continuing review. Opening an IRB continuing review will create an eCHPS continuing review if there is an approved request for CHPS resources. CHPS CR submission and review is a separate activity from eIRB.

For Cooperative Agreement studies or protocols that do not have an IRB expiration date, an annual CHPS CR is still required. The CHPS administrative team will need to open the CR manually for the study team to complete.

Once the eCHPS CR is created, the study team and select “Edit Continuing Review” within the eCHPS R workspace to open the application and complete the questions on the first page. If the IRB and CHPS CRs are linked, any additional information is shared from the eIRB submission. Once the form in completed, please submit for CHPS review. The request will be reviewed by the Directors of the Cores being utilized and our Resource Committee.

Please contact the CHPS administrative team if you need support:

  • John Krall, Administrative Director, krallj [at] chop.edu
  • Eileen Ford, Administrative Manager, forde [at] chop.edu
  • Beth Schwartzman, Clinical Research Project Manager, schwartzmann [at] chop.edu