- Active clinical trials: ~215
- Study coordinators within
the CRSO: 50
The Clinical Research Support Office (CRSO) provides high quality services to assist investigators and study teams in the start-up, execution, and completion of clinical research studies.
The CRSO offers comprehensive support in the following areas:
- Research Staffing
- Clinical Trial Financial Management
- CHOP Research Navigator
- Clinical Trial Support
- Recruitment Enhancement
- IND/IDE Support
Contact: Jennifer Goldfarb, Senior Director, 267-426-7909
Clinical Trial Support
Provides services related to the support of clinical trials, including the implementation, training, and support of OnCore, an enterprise Clinical Trial Management System (CTMS).
Negotiates the following types of contracting agreements:
- Industry-funded human subjects research (both industry-initiated and investigator-initiated)
- Subcontracts from industry-funded human subjects research
- Master agreements and Letters of Intent to pursue industry-funded human subjects research
- eIND and sIND expanded access agreements
REC services include:
- Recruitment plan consultation and development
- Facilitate recruitment opportunities across CHOP and UPenn
- Identification of potential participants through the Electronic Health Record (HER)
- Paper and electronic invitations to potential participants
- Study advertising to all CHOP employees
Clinical research professional staff with diverse backgrounds, education, and experience are available to help clinical investigators and teams. Our staff are experienced with many types of clinical research studies.
Available full or part-time, temporary or long-term.
Some examples of support provided include:
- Full study coordination activities
- Study start up (IRB, CTRB, and eTrack submissions)
- Preparation of regulatory documents and consent forms
- Subject recruiting and consenting
- Data entry and management
- Study visit coordination
- Safety reporting
Clinical Trial Financial Management
CTFM provides financial management throughout the lifecycle of a clinical research study and assists in the following areas:
- Budget preparation and negotiation
- Research subject registration and study visit financials
- Research procedure charge review
- Sponsor invoicing
- Grant close outs
Investigation New Drug/Investigational Device Exemption (IND/IDE) Support
Provides regulatory and operational support for CHOP physician-initiated FDA regulated clinical trials.
- Guidance on whether a drug/device is exempt from IND/IDE designation
- Protocol development and review
- FDA regulatory strategy, submissions, and reporting requirements
- Training, education, tools, and resources
- Maintenance of institutional records of FDA submissions
CHOP Research Navigator
Serves as a liaison that connects research teams to available research resources at the institute.
- Addressing inquiries
- Listening to your concerns
- Consultation for your ideas
- Disseminating relevant information across the institute
- Proposing opportunities for process improvement and education
If you don’t know where to start, start with the Research Navigator.