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eSIFTER, which stands for Study Intake Form to Expedite Research, is a centralized repository for study start up information required to support various processes associated with the initiation of a new study, such as the OnCore protocol and calendar build, build of the study in Epic and development of the study budget and contract. eSIFTER is also used to submit information necessary to operationalize changes which are associated with amendments for existing studies, including the calendar and / or budget in OnCore as well as the contract. While eSIFTER is accessed through eIRB and each eSIFTER record is associated with an IRB study, eSIFTER is not part of the IRB. Submitting information in eSIFTER should be done in addition to observing existing processes in eIRB.
To allow process owners to receive all of the information that they need in one location, but eliminate the need for duplicate data entry by study teams, eSIFTER includes many questions which are shared with eIRB. This means that while in a pre-submission state, a shared question may be answered either within eSIFTER or the IRB study and will be shared accordingly. Once the study in eIRB is submitted, eSIFTER will evaluate the current smartform path that is associated with the IRB study. eIRB is the source of truth for shared questions which are included in the current smartform path and edits to these questions must be made there. Shared questions, which have not been included in the current smartform path of the IRB study, will remain editable in eSIFTER.
Each area below represents a SIFTER sub-project:
- 1.01 OnCore: Supports data collection needed to build an OnCore protocol and calendar. (Process Owner: OnCore Support Team)
- 1.02 Budget: Support data collection needed to create a budget in OnCore. (Process Owner: CTFM Budget Analysts)
- 1.03 Contracts: Supports data collection needed for the development of a clinical trial agreement. (Process Owner: Contracts Administrators)
- 1.04 Drug Information: Supports data collection needed for studies which involve drugs / biologics or placebos. (Process Owner: Investigational Drug Service)
- 1.05 Payment to Subjects / Families: Supports data collection needed if study participants or parents will receive any type of reimbursement / compensation for study participation. (CTFM Registration and Charge Review Analysts)
- 1.06 Epic Study Build: Supports data collection needed to complete the build of study records, manage study team access to the study record and develop order sets and / or operational tools in Epic. (PARC Support and Epic Core Clinical Operations)
SIFTER has been designed to provide the ability to submit sub-projects independently, based on an immediate need. In addition, SIFTER will also be used to support information gathering related to amendments which may involve changes to the OnCore protocol calendar and / or budget, changes to the contract, changes to case report forms (CRFs) in OnCore and changes that would impact Epic Research. The information collected within a SIFTER amendment is intended to supplement amendment information already being collecting within eIRB.
A eSIFTER should be created for all new industry or non-industry sponsored studies that have hospital / professional billable research services (including through the CHPS program), as these studies will need to be built and maintained in OnCore Clinical Trial Management System.
Request Access to this module in eResearch
In order to access this module:
- You must have an Active Directory (AD) account at CHOP
- You must first request access to eResearch
- Request access to eResearch using the Access Request Form
Once your request is approved, you can access any of the eResearch modules.
eResearch access grants access to all eResearch modules (eIRB, eSPA, etc).