Information for Sponsors
As part of Kaiser Permanente’s integrated care system in Southern California, we participate in clinical trials that have the potential to improve care and health outcomes for our members and the communities we serve.
Our region has clinical trials programs in oncology (adult, gynecologic, pediatric, and surgical/radiation oncology), urology, gynecology, neurology, dermatology, metabolic diseases, nephrology, ophthalmology, infectious disease, cardiology, hepatology, and vascular surgery. Our research division has the ability to conduct clinical trials in almost any therapeutic area. Our experience with clinical trials includes:
- phase II to phase IV drug and biologics
- pilot, pivotal, and post-market device trials, and
- pragmatic trials
Connected care and electronic health records
As an integrated health care system—encompassing medical group, medical facilities, and health plan—our region provides an ideal environment for clinical trials research. A robust electronic health record, Kaiser Permanente HealthConnect®, links health information from different points of care, spanning hospital stays and medical office visits as well as orders for labs, medication, radiology, and other services.
Diverse patient population and extensive care operations
Southern California is Kaiser Permanente’s largest region, serving over 4.5 million members. The member population reflects the racial and ethnic diversity of the region. Kaiser Permanente has 15 medical centers and 231 medical offices in Southern California. For more information about our region, visit the Fast Facts section.
Experienced clinical trials investigators
Our investigators are practicing physicians who care for a diverse population of patients within Kaiser Permanente Southern California’s integrated system. They bring a real-world clinical perspective to their research as they seek to understand the impact of new drugs, biologics, and devices on patient health.
More than 140 practicing physicians from diverse sub-specialties serve as clinical trials investigators. They collaborate with hundreds of other multidisciplinary care providers, who provide clinical expertise from more than a dozen therapeutic areas (see About Clinical Trials).
Dedicated clinical trials staff
The Division of Clinical Trials Research within the Department of Research & Evaluation provides robust staffing and support for our principal investigators. More than 100 dedicated and experienced clinical trials staff provide support to our principal investigators. Some of the services our staff provides include:
- Orienting and training for clinician investigators and site staff
- Assisting with site feasibility assessment for potential studies
- Recruiting and hiring study site staff to support studies
- Developing workflow processes for successful participant recruitment and study implementation and management
- Reviewing for quality assurance and compliance to address and prevent noncompliance
- Assisting with external audit (e.g., Food and Drug Administration or cooperative group) preparation
- Supporting specific study activities, such as coordinating study monitor visits, site initiation and closeout visits, study data management, study procedures, and study lab specimens processing and shipping.
Regulatory specialists provide support to clinician investigators and staff to process IRB and regulatory submissions and ensure compliance with applicable regulations, policies, and procedures including the protection of the safety, rights, and welfare of research participants.
Learn more about how to work with us
If you are interested in exploring opportunities to partner with us on a clinical trial, please reach out to our clinical trials team. Below are answers to frequently asked questions about our program.
How do you proceed with participation in a clinical trial?
Before deciding if we will proceed with a clinical trial, we will execute a Confidentiality Disclosure Agreement (see “How to Work with Us” information in the right column), evaluate the protocol, and identify:
- physician interest in the trial protocol,
- a potential principal investigator in therapeutic area,
- feasibility within Kaiser Permanente, and
- value and risk to Kaiser Permanente patients.
Once we have confirmed a principal investigator, he or she is required to obtain additional approvals. This includes approvals from
- the local area research chair, chief of service, and department administrator,
- the Clinical Trial Oversight Board, and
- Kaiser Permanente Southern California’s Institutional Review Board.
Who negotiates contracts for clinical trials?
The Central Business Office team manages all research contracts for Kaiser Permanente Southern California. This ensures that contracts comply with institutional requirements as well as federal and state regulations.
Each study protocol is assigned to a Contracts and Grants Administrator who is responsible for that specific protocol. The administrator handles all aspects of budget development and contract negotiation on behalf of the principal investigator and the Southern California Permanente Medical Group.
After reviewing the sponsor’s protocol with the study team, the administrator will prepare a budget for the study that will include study costs, including a start-up fee.
How long does it typically take to negotiate a budget/contract?
Do you have an internal quality and compliance program?
Yes. The Division of Clinical Trials Research has a dedicated quality and compliance oversight program. Some of the services available to principal investigators and study site staff include:
- Reviewing for quality assurance and compliance to address and prevent noncompliance
- Assisting with external audit (e.g., FDA or cooperative group) preparation
Do you have a local Institutional Review Board?
Yes. Our research studies are reviewed by the Kaiser Permanente Southern California IRB. Meetings are conducted monthly, with applications due approximately 3 weeks prior to meeting date (see schedule here).
What kind of training do principal investigators and staff receive?
The Division of Clinical Trials Research requires clinician investigators and study site staff to have the following training completed before their involvement in a clinical trial:
- Collaborative Institutional Training Initiative Good Clinical Practice for clinical trials
- Collaborative Institutional Training Initiative Conflict of Interest
- HIPAA Privacy Rule and Research Training
- Principal Investigator Reportable Event and Incident Requirements (Kaiser Permanente Southern California-Institutional Review Board SOP-502)
- Investigational Drug Management Training, if applicable
- Department of Transportation CFR 49 Training – Shipment of Hazardous Materials, if applicable
How do you support source documentation and study data management?
Our electronic health record system, Kaiser Permanente HealthConnect®, is the medical record for all inpatient, ambulatory, and Kaiser Permanente services, including laboratory, pharmacy, and radiology. It provides the source data for clinical trials conducted within these facilities.
Subject-specific hard-copy study charts and hard-copy worksheets may be used to help organize source documents for studies in which a large amount of research data or complicated information will be collected.
What support is available to monitor and audit studies?
Do you coordinate investigational drug and pharmacy services?
Can you support specimen collection and shipping?
Yes. Principal investigators and study site staff have experience with a variety of labs. Those directly involved in the packing and shipping of specimens must have current certification for the Department of Transportation. The DOT training is provided by Kaiser Permanente Southern California.
In general, clinical trials conducted in our region utilize licensed phlebotomists within the Southern California Permanente Medical Group Regional Reference Laboratories. For more information on our laboratory capabilities, see the Facilities and Labs section.
What are your record retention practices?
We retain study records as required by federal and state regulations, protocols, and clinical trial agreements. When multiple retention periods apply, we follow the longest period (or most stringent standard). Unless otherwise specified in the clinical trial agreement, study records are retained no longer than 10 years after the study is closed with the Institutional Review Board.
In general, study records are archived within one year after closure with approval from sponsor. Standard practice is to send the records to an approved long-term storage facility.
More questions? Contact us.
If you have questions or need additional information, please contact:
Hai Linh T. Kerrigan, PharmD, Division Research Administrator at Clinical.Trials@kp.org
How to work with us
Our program works with cooperative groups, federal sponsors, and industry sponsors to conduct clinical trials for investigational drugs, biologics, and devices. To work with us, follow these steps.
Step 1: Contact us
If you represent a sponsor or a contract research organization interested in partnering with us, your first step is to contact our clinical trials team.
Step 2: Sign confidentiality agreement
The team will work with you to establish a confidentiality agreement, unless one is already in place. On average, a new agreement can be turned around in 24 to 48 hours.
Step 3: Send protocol for review
We will assess feasibility of the protocol and identify possible investigators and study sites. When this is completed, we will contact you.
Step 4: Negotiate budget/contract
An administrator from our Central Business Office will be assigned to manage budget and contract negotiation.
Step 5: Submit protocol to IRB
Clinical trials staff will assist with study application submissions to our regional Institutional Review Board. This can be done concurrently with the budget and contract negotiations.
Step 6: Initiate Trial
Once the clinical trials agreement (contract) is fully executed and the IRB approval is received, the study can be initiated at the site. The clinical trials team will work with you from study start up to closeout.