Geisinger provides extensive value to its sponsors.
General Information
Clinical Research Resources (CRR)
Clinical Research Resources includes five research cores at Geisinger:
Office of Clinical Research Operations (OCRO)
Investigator Initiated Research Operations
Biostatistics Core
Phonemic analytics & Clinical data Core
Survey Research and Recruitment Core
Audits and Inspections
No 483 warning letters issued from three FDA audits over the past 10 years
OCRO SOPs and Best Practices
SOPs available upon request
Staff
More than a decade of experience managing trials in multiple therapeutic areas-cardiovascular, pulmonary, gastroenterology, endocrine, OB/GYN, palliative care, critical care, laboratory medicine, general internal medicine.
More than 90% of Clinical Research Coordinators (CRC) are RNs
All CRC’s and Project Managers are required to be SOCRA and/or ACRP certified.
All study staff and investigators are required to complete and maintain Basic Human Subjects, Responsible Conduct for Research and Good Clinical Practice training through the Collaborative Institutional Training Initiative (CITI)
Study Monitors
Wireless Internet available
CRO & Sponsor Monitors are provided with laptop and access to subjects’ EMR; 2 weeks advance notice needed for access approval
Space provided for monitoring visits
Remote monitoring access available with provisions
Different Types of Sponsor Experience/Funding Sources
Industry
NIH, NIDDK, NHLBI, Foundations
Investigator Initiated
Trial Phase Capabilities
II, III, IV
Miscellaneous
Epic: EMR 21 CFR Part II compliant
Dedicated computers for each staff member
High speed internet access
Internet browser–Internet Explorer Version 11.0
Prompt reporting of inpatient hospitalization SAEs through a unique process which alerts study staff to participants’ in-system hospitalizations on a daily basis
Long Term Storage
GSS Storage Facility
400 Railroad St., Danville, PA 17821
Contains information on > 4 million unique patients.
Records provide real time and historical data useful in pre-identifying potentially eligible study patients.
Allows access for provider referrals in multiple therapeutic areas.
Large Trial Recruitment Process
Using the Electronic Medical Record (EMR), data pulls specific to study inclusion/exclusion criteria are programmed primarily by ICD and procedure codes.
Identified eligible patients are invited to learn more about the study.
Potential patients are listed on a study tracker and contacted by staff.
Our process has shown to deliver high enrollment rates, realistic enrollment expectations and low screen failure rates.
Dedicated Research Data & Recruitment Manager
Oversees implementation of trial recruitment strategies and enrollment optimization.
Facilitates management of data requests, externally and internally
Excellent Retention Rates
The experience and dedication of OCRO staff, convenient patient tools and a low out-migration rate results in excellent retention rates that are well above average.
OCRO has a 10+ year history of conducting 3-5 year outcomes trials with excellent retention rates over 95%
MyGeisinger.org
MyGeisinger.org - A patient web-based portal that provides a convenient way for patients to access their medical record, contact providers/study staff and manage their health.
MyChart Mobile - This app provides a MyGeisinger user with secure access to features such as messaging providers, viewing your own and family medical records, upcoming and past appointments, test results, etc. These tools are helpful with both recruitment and retention of study patients.
Full Board review occurs twice monthly. Submission deadline for board review required approximately 3 weeks prior to meeting date.
Exempt and Expedited submissions take approximately 2-3 weeks for review and approval.
Full Board submissions typically take 1-2 months from submission to approval.
GIRB uses iRIS, an electronic document platform for all submissions and tracking
The IRB consists of 11 members, 2 co-chairs, 2 ex-officio members, plus 12 alternates.
GIRB is fully accredited by AAHRPP
HHS Federal-wide Assurance Protection for Human Subjects
Number: FWA00000063
Expires 17SEP2027
Regulatory and IRB Support
One Sr. CRC and a Project Coordinator dedicated to supporting regulatory tasks for the group.
IRB submissions, amendments, communications and tracking completed centrally for GHS OCRO through this central support service
IRB Fees
A one-time fee will be charged for IRB review of all externally-funded research studies. The IRB fee covers initial review and all continuing reviews, amendments and unanticipated problems submitted to the IRB for the life of the study.
Centralized team responsible for CDA’s, agreements, contract & budget negotiation at all Geisinger sites.
Average timeline for contract execution: 3-4 months
Current overhead and applicable fees will apply as appropriate
Contracting Entity: Geisinger Clinic (for all Geisinger sites)
Payee & Address: Geisinger Clinic
Attn: Research Finance, MC 30-69
100 N. Academy Avenue
Danville, PA 17822-3069 researchach@geisinger.edu
Point of Contact: Candice Laubach, MBA, CRCP (or designee assigned) Sr. Director, Research Administration and Strategic Initiatives Geisinger Clinic 100 N. Academy Ave Danville, PA 17822-4400 researchcontracts@geisinger.edu Phone: 570-214-5067
Academic Medical Center and Outpatient Specialty Clinics
Number of Beds North Central Region
560 beds at Geisinger Medical Center (GMC)
72 beds at Geisinger Bloomsburg Hospital
55 beds at Geisinger Shamokin Area Hospital
123 beds at Geisinger Lewistown
311 beds at Holy Spirit Hospital
Research Staffing
18 Clinical Research Coordinators
14 Registered Nurses
4 Cardiovascular Research Coordinators
7 Research Assistants
6 Project Managers
2 Project Coordinators
Investigational Pharmacy
Contact: Adam Gross, PharmD, CCRP
Coordinator – Investigational Drug Service
Enterprise Pharmacy
100 Academy Avenue
Danville, PA 17822-4201
Services & Equipment
Drug procurement, preparation & labeling
Secure, monitored storage
Accountability (Vestigo)
Storage room and refrigerator equipped with the TempTrak 24-hour monitoring and alarm system. Traceable to NIST standards.
Monthly digital temperature records accessible to study staff/sponsors
Refrigerator connected to the hospital’s back-up generator system
Disposal of study drug; incineration at off-campus sites
Local Laboratory
Contact: Mike Weaver
Analytical Specialist
Referred Lab Testing
Referred Testing Staff all IATA Certified CLIA and CAP certificates available
Services & Equipment
Manages collection and processing of research samples (blood or tissue)
Packaging and shipment of samples outside of Geisinger
Research sample storage, refrigerated or frozen
Freezers and refrigerators used to store samples equipped with electronic TempTrak 24-hour monitoring and alarm system.
Monthly temperature records accessible to study staff/sponsors
Refrigerators/freezers connected to the hospital’s back-up generator system
Equipment calibration/validation completed annually with records accessible to study staff
-20 and -70 degree C freezers
On site in-patient and out-patient facilities and equipment
ECG machines, scales, blood pressure cuffs and sphygmomanometers, otoscopes.
DEXA, X-ray, MRI, CT, echo, etc.
