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The Center for Human and Phenomic Science administrative team is available to discuss services, pricing, and any other questions regarding accessing and using CHPS. Please feel free to contact our administrative team to discuss your project.
The Research Institute provides a helpful overview of all aspects involved to assist clinical research personnel to start a clinical research study.
Proposal Review Process
To submit a proposal to utilize CHPS services, study teams will need to complete and submit an eCHPS electronic application, which is a part of the eResearch system. An eCHPS application is opened when study teams note in their eIRB applications that they will use CHPS services. See our helpful how-to guide to CHPS Submissions, Amendments, and Continuing Reviews to get started with your eCHPS application
Once submitted, CHPS holds monthly Resource Committee meetings where all requests for our resources are reviewed. Proposals cannot utilize CHPS until they receive both IRB and CHPS approval.
CHPS will consider expedited protocol approvals under certain circumstances:
- Compassionate use, e.g., use of a potentially life-saving drug in a patient who is desperately ill.
- Circumstances in which a brief opportunity to capture a rare patient population/circumstance could not be predicted in advance.
- Under rare circumstances, if data are needed urgently due to grant submission or expiration dates, and if substantiated reasons for not submitting the CHPS proposal in a more timely manner are provided.
For additional information, please contact the CHPS Administrative Director or Administrative Staff.
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.
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.
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@chop.edu.
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.
CHPS Research Budgets
CHPS charges for services, and these costs must be included in all budgets. All studies or amendments approved by CHPS with study protocol-specific training will be charged an hourly fee per CHPS staff completing each required training. Please make sure your budgets include funds for these activities.
The OnCore Support Team and the CTFM Budget Team will use the SIFTER information to develop budgets in OnCore. Please reach out to the CTFM Budget Team with any questions. Please ensure that your OnCore study is fully signed-off and is in the status of released/open to accrual in OnCore before registering or scheduling subjects for CHPS visits.
CHPS uses Clinical Trials Financial Management (CTFM) to facilitate billing and invoicing for studies that utilize CHPS services. CTFM will collect service information from CHPS Cores and prepare monthly invoices for study teams.