Partnering in Research and Innovation
Welcome to the Clinical Trials Office (CTO). Whether you are a novice investigator or an experienced researcher aiming to commence a new study, our knowledgeable and committed CTO team is prepared to assist you. We’re here to help you navigate the regulatory, institutional, operational, and educational requirements essential for conducting clinical research with the highest quality standards.
The CTO coordinates and manages all sponsored clinical trials and clinical research studies conducted at St. Luke’s.
Getting started: research readiness
All researchers at St. Luke’s must complete “research readiness” requirements and receive a “green light” from our regulatory team before joining any study or performing any research activities. Please follow the detailed instructions below to get research ready.
It is the responsibility of study personnel, including Investigators, to remain in compliance with research readiness requirements and not allow any qualifications to lapse. The CTO team will notify you as expiration approaches. It is important to address this outreach immediately to ensure regulatory compliance on your study.
When completing your trainings and forms, please use your full legal name on all regulatory documents.
If you need support getting research ready, please contact Jasdip Kaur, Senior Study Start-Up Project Coordinator.
Jasdip.Kaur@sluhn.org | 484-658-1828
Complete training available here: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
IMPORTANT REQUIREMENT: Before exiting the training, you must print the completion certificate, save an electronic copy, and email it to Jasdip Kaur (Jasdip.Kaur@sluhn.org). Please note that there is no way to retrieve the certificate once you exit the program.
The NIH tutorial certificate is valid for four years. IRB administration staff will notify you and request an updated certificate as expiration approaches.
Complete the form here: FCOI Form and keep your confirmation number.
IMPORTANT REQUIREMENT: Email your confirmation number to Jasdip Kaur (Jasdip.Kaur@sluhn.org).
This form is required to be completed annually. IRB administration staff will notify you and request your annual form as expiration approaches.
You are required to complete two online courses which are outlined below. Both online trainings take approximately 4-5 hours to complete. Once completed, please save and email a copy of your completion certificate to Jasdip.Kaur@sluhn.org.
- Registration link: www.citiprogram.org
- Select Your Organization Affiliation: St. Luke’s Hospital & Health Network – Bethlehem, PA
- Please make sure to save your username and password in a safe place.
Course 1: Good Clinical Practice
- The CITI Program – GCP Course completion certificate is valid for 3 years.
- The CITI Program and St. Luke’s Clinical Trials Office staff will notify you and request a refresher certificate as expiration approaches.
Course 2: Biomedical Researchers
- The CITI Program – Biomedical Researchers Course is a one-time course. Your completion certificate does not expire.
If you already have an account with CITI Program, please login and affiliate your account with St. Luke’s Hospital & Health Network – Bethlehem, PA. You may use current valid training certificates from previous institutions to satisfy these training requirements. You are encouraged to retake the course through SLUHN if you are nearing the 3-year expiration mark.
- Prepare a research-focused CV at this link:
- Once completed, print your CV and sign and date the first page. Scan and email a copy to Jasdip Kaur (Jasdip.Kaur@sluhn.org).
Your CV is valid for two years. The Clinical Trials Office staff will request an updated CV as expiration approaches.
Please provide your current valid medical or other license (MD, DO, PA, CRNP, RN, Pharm, other) to Jasdip Kaur (Jasdip.Kaur@sluhn.org).
Florence eBinders is an electronic Investigator Site File (or Regulatory Binder) maintained by the St. Luke’s Clinical Trials Office. You must complete this training to receive login credentials for access to study documents and to complete electronic signature on study documents as necessary.
Researcher Training (Investigators, Pharmacist/Pharmacy Technician, other)
- This training can be completed here: PI Training for eTMF and eISF (3 modules, 15 minutes)
- Register Organization: St. Luke’s University Health Network
- Save and email a copy of your completed certificate to Jasdip Kaur (Jasdip.Kaur@sluhn.org)
- Florence eBinders training is one-time. Your completion certificate does not expire. As needed, there are training modules that are available for follow-up training.
- Following completion of the Florence training, you will receive an email invitation to complete the registration within 48 – 72 hours. Once received, click on the link in the invite and follow the prompts to activate your account.
Study Staff Training (Clinical Trials Office and Investigational Pharmacist/Technician ONLY)
- This training can be completed here: Florence eBinders training for study staff (11 modules, 1.5 hours)
- Register Organization: St. Luke’s University Health Network
- Save and email a copy of your completed certificate to Jasdip Kaur (Jasdip.Kaur@sluhn.org)
- Florence eBinders training is one-time. Your completion certificate does not expire. As needed, there are training modules that are available for follow-up training.
- Following completion of the Florence training, you will receive an email invitation to complete the registration within 48 – 72 hours. Once received, click on the link in the invite and follow the prompts to activate your account.
Supporting our research community
The Clinical Trials Office (CTO) supports all aspects of clinical research, from initial feasibility to final record archiving. As a central resource for investigators, the CTO ensures trials are efficient, compliant, and uphold high standards of patient care. We provide expert guidance and support at every stage, helping investigators focus on medical discoveries and improving patient outcomes.
All new sponsored study opportunities must be evaluated for feasibility by the St. Luke’s Clinical Trials Office before launching at St. Luke’s. Our team works with investigators and other key stakeholders to assess feasibility by considering:
- Medical and Scientific Rationale & Study Design
- Research Needs, Interests, and Priorities
- Patient Population Data Analytics
- Logistical and Operational Feasibility
- Resource Availability
- Funding & Budget
Our CTO team will work in close collaboration with principal investigators to complete sponsor and internal feasibility questionnaires and analyze study costs to ensure your study is set up for success.
Our oncology clinical trials program Scientific Review Committee (SRC) is the first step in study feasibility. The Committee evaluates all new cancer clinical trials for the above criteria and reviews accrual progress every twelve months at IRB renewal. Trials must be approved by the SRC prior to initiating start-up activities.
Compliance with federal, state, and local regulations, standards, and guidelines, as well as institutional policies and procedures is essential. The CTO has experienced dedicated staff that will support the oversight, completion, and maintenance of the following:
Regulatory Requirements
- Training and Qualifications: All Investigators and Key Personnel must complete research readiness requirements to ensure adherence to ethical and regulatory standards.
- Institutional Review Board (IRB) Oversight: All human subject research must be reviewed and approved by an IRB before any study-related activities are performed and must be maintained for the duration of the study. NOTE: PIs are required to present their studies at IRB meetings. Cayuse is our IRB portal system. Cayuse training can be found here.
- Essential Regulatory Documents: All research studies must have an Investigator Site File (or Regulatory Binder) created and maintained within the CTO which contains relevant essential regulatory documents for the study. These documents include, but are not limited to, 1572 or equivalent, Finance Disclosure Form (FDF), and Delegation of Authority Log (DOAL). Florence eBinders is our eRegulatory system.
- IT Security & HIPAA/Patient Privacy: All electronic systems and devices being used in research studies are vetted through St. Luke’s IT security and Enterprise Architecture to ensure the protection of participant data.
Billing Compliance is critical to the appropriate financial conduct of clinical research. The CTO has experienced staff that will support the oversight, completion, and maintenance of the following in both the pre- and post-award environments:
Budget
- Coverage Analysis (CA): Studies that meet certain criteria (qualifying studies) require a CA to ensure proper billing pathways for study tests, procedures, and services.
- Cost Analysis and Study Budget: CTO staff will conduct an initial cost analysis and develop, negotiate, and provide ongoing management of study budget for each study.
- Study Financial Approval: Certain studies required approval from the Chief and/or Chair of the medical department before proceeding with start-up. CTO staff will prepare documentation and support obtaining signatures.
Contract
- Confidentiality Agreement (CA): Many sponsors require a confidentiality agreement be in place prior to sharing the study protocol and other study documents. Investigators are not permitted to sign CAs on behalf of the Network.
- Clinical Trial Agreement (CTA) or Master: Sponsored studies require contract negotiation with the institution’s legal and financial teams. Master agreements are recommended with study sponsors that St. Luke’s partners with frequently.
- Clinical Trials Services Agreement: Some studies require services that are external to St. Luke’s. The services agreement must be in place prior to study initiation.
- Acceptable Use Agreement (AUA): An AUA is required for monitoring of studies to ensure appropriate conduct while accessing St. Luke’s Network. CTO staff will work with sponsors to put this agreement in place with study monitors.
Billing
- Epic Research Module: CTO staff will build study protocols within Epic, conduct two-tier billing reviews, and provide ongoing maintenance of study builds for the duration of studies.
- Sponsor Billing and Collections: Sponsors will be invoiced and payment will be collected per agreed upon budget and signed contract.
- Financial Audits: Research Finance staff will conduct audits to ensure appropriate billing of research studies.
Grants
Research finance staff will support the following for grant funded research:
- Correspondence with coordinating site
- Letter of Intent
- Statement of Work
- BioSketches
- Facilities and Resources
- Sub-Award Agreements
- Budget Development
All sponsored-research studies are started up and conducted through the Clinical Trials Office (CTO). The CTO has experienced dedicated staff that will support all of the following:
Study Start-up
- Pre-Study Visits (PSV): As the final step in feasibility, clinical trials management and assigned research coordinators/nurses review each study protocol and are present at PSVs with study sponsors.
- Site Initiation Visit (SIV): As the final step in start-up, clinical trials management and assigned research coordinators/nurses/associates will be present for the SIV which serves as sponsor protocol training prior to study activation.
Study Conduct
- Pre-Screening and Screening: Clinical Research Coordinators/Nurses (CRC/N) will use existing resources to pre-screen and complete screening activities to identify patients who may be eligible for available clinical studies.
- Informed Consent Process: CRC/N will be present during consent and will support the informed consent process within the scope of their role and qualifications.
- Participant Study Visit Coordination: CRC/N will work closely with patients to navigate them through study requirements (e.g. scheduling treatments, tests, procedures) ensuring protocol adherence, prioritizing patient safety and quality data collection. Clinical trials staff will be present a study visits as necessary.
- Safety Management: CRC/N will support the logging and reporting of safety events to sponsor and to regulatory for submission to the IRB per policies and procedures.
- Data Management: CRC/N and/or Associates will perform data entry and query resolution in compliance with protocol and institutional procedures.
All sponsored-research studies undergo ongoing monitoring hosted by the Clinical Trials Office (CTO) and Principal Investigators. The CTO has experienced dedicated staff that will support all of the following:
Regulatory Maintenance
- Investigator Site File (ISF): CTO teams will maintain study documentation in compliance with applicable regulations, the protocol, and institutional policies and procedures for the duration of the study through closeout and archival.
- Institutional Review Board (IRB): Study IRB approvals will be maintained in compliance with relevant regulations and institutional policies and procedures including renewals, modifications, and closeout.
Billing Compliance
- Invoicing: Study related activities will undergo billing review and will be invoiced appropriately per the coverage analysis and agreed upon budget and contract.
- Amendments: Study amendments are reviewed for coverage analysis, budget, and contract impact and updated appropriately.
Monitoring & Audits
- Interim Monitoring Visits (IMV): Research Regulatory and Clinical Operations teams host study sponsors and are present for monitoring visits with study monitors and Investigators. Teams will provide documentation and respond to queries as required.
- Audits: Research Regulatory and Clinical Operations teams prepare for and participate in study audits and contribute to post-audit activities.
- Closeout Visit (COV): As the final step in study conduct, clinical trials management and assigned research regulatory and clinical research coordinators/nurses will prepare the study for closeout and are present at COVs with study sponsors and Investigators.
- Record Archival: CTO teams will compile study records and prepare them for shipment to our off-site climate controlled storage facility for the period agreed upon in the study agreement.
About our clinical trials office
Supporting the complex and multifaceted nature of clinical research
St. Luke’s Clinical Trials Office (CTO) plays a pivotal role in the execution and management of clinical research. We ensure that clinical trials are conducted efficiently, ethically, and in compliance with regulatory standards. Our office structure is designed to support these goals at every stage of a clinical trial by providing comprehensive oversight regarding leadership and administration, regulatory affairs, clinical operations and study coordination, research finance, data management and analytics, pharmacy coordination, quality assurance, and patient and participant support. The structured approach of our CTO advances medical knowledge, improves patient outcomes, and contributes to the overall success of clinical research efforts across the Network.
Additionally, our CTO office works in collaboration with various stakeholders, including academic institutions, healthcare providers, and pharmaceutical and medical device companies. These partnerships enhance the scope and impact of clinical research. Effective communication and coordination among these entities are crucial for the seamless execution of trials.
To learn more, please contact our Clinical Trials Office: clinicaltrials@sluhn.org | 484-658-5080
A vital partner in your research
Our CTO experts are your #1 resource
All new sponsored study opportunities must be evaluated and conducted through the St. Luke’s Clinical Trials Office (CTO). Our robust CTO team provides invaluable support to you from interest through to implementation. Here are all of the ways we partner and are a resource to you.
Please note that this is a high-level overview of the support the Clinical Trials Office provides and does not fully describe all processes and procedures involved in the conduct of clinical trials and research at St. Luke’s.
Need Assistance? Contact the Clinical Trials Office: clinicaltrials@sluhn.org | 484-658-5080