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CHPS Nurse Practitioner Core Services
Published on Jun 29, 2022 · Last Updated 5 months 3 weeks ago
The Center for Human Phenomic Science (CHPS) Nurse Practitioner Core offers a variety of services for investigators' study needs.
- Complete medical histories, medication reconciliation, adverse event documentation, and/or review of systems
- Perform protocol specific physical exams, including pubertal staging
- Oversee questionnaire/survey completion, including C-SSRS
- Write orders in EPIC as needed; work with study teams to develop order sets for study protocols in EPIC
- Review safety labs and follow up with clinical or research team
- Documentation of pertinent to research procedures, via EPIC notes, REDCap entry, or paper study CRFs
- Oversee research procedures, such as infusions, continuous glucose monitoring, OGTT, MMTT, and glucose potentiated arginine test (GPA)
- Address urgent issues due to research procedures such as hypoglycemia, hyperglycemia, rashes, and infusion reactions, and directly interface with research team/Principal Investigator for additional assessments and management
- Coordinate with the study PI for study patient follow-up in the CHPS clinic or via telehealth due to unanticipated issues, adverse events, abnormal laboratory results, or other items requiring attention
- Collaborate with study teams to develop and clarify protocol-specific Manuals of Procedures
All studies using the CHPS Nurse Practitioner Core require IRB and CHPS approval before CHPS services can be provided or study visits are scheduled.
Prior to scheduling any patient visits and after your study is approved by the CHPS Resource Committee, please set up a start-up meeting with the NP to review study protocol and procedures with your team.
Schedule CHPS NP appointments through CHPS RN Outpatient Lab through EPIC InBasket.
CHPS Nurse Practitioner Regulatory Requirements
Collaborative Agreement
The Collaborative Agreement is a document required by the state of Pennsylvania between an NP and a supervising physician. Each division at CHOP must have a collaborative agreement in place with the CHPS NP, and the PI must be one of the physicians listed on this agreement in order to begin using the NP service. The CHPS Administrative team can assist you in determining if your PI is included on existing NP CHOP Collaborative Agreements and provide you with the additional information.
IRB Application
This will vary from study to study. Similar to other CHPS staff, the NP will not be required to be listed in your IRB application. The NP is simply carrying out portions of your protocol and not considered by the IRB to be performing Human Subjects Research. All CHPS staff are compliant with CHOP Research Institute GCRC and CITI training.
Delegation Log
This may vary from study to study but will likely be required. Industry initiated studies will have their own specifications. If the NP is ordering a medication that is prepared and dispensed from the investigational pharmacy or frequently writing orders in EPIC, the NP should be listed on the delegation log. This may be required for IND studies as well.
Form 1572
The NP may be required to sign the 1572. If the NP will be prescribing investigational medications or ordering labs to be run at CHOP's laboratory, it is recommended by the Office of Research Compliance that the NP be listed on the Form 1572 as a sub-investigator. This may require the NP to complete the study specific training required for the role.