About Us
The Clinical Trials Program (CTP), under the direction of Medical Director Alan Go, MD, Senior Managing Director Victor Chen, and Associate Directors Andrew Ambrosy, MD, and Paradi Mirmirani, MD, is a centralized operational entity that is comprised of multiple sites across the Northern California service region. The CTP provides Kaiser Permanente members with direct access to high-quality clinical trials evaluating novel drugs and devices. The CTP also facilitates access to therapies through Compassionate Use (CU), Humanitarian Use Devices (HUD), and Early Access Programs (EAP).
The CTP advances research and optimizes clinical care and the member experience by expanding access to high-quality clinical trials across a range of interventions and therapeutic areas. KP members looking to participate in groundbreaking clinical trials can use the KP Study Search site to find specific trials in all the Kaiser Permanente regions.
The services we provide to TPMG physicians and other research partners include tools and infrastructure that can help ease the burden of conducting trials. This includes:
- Comprehensive protocol evaluation and preparation
- Trained staff and effective tools and processes
- Regulatory support as well as quality and financial monitoring
If you are a Kaiser Permanente clinician in Northern California who would like to initiate a research project or request research support or consultation from the CTP, please submit a request via the Research Collaboration Portal (RCP).
Collaborate With Us
Kaiser Permanente Northern California (KPNC) has a long history of successful collaboration on research studies with a wide range of other Kaiser Permanente (KP) and non-KP research entities. Because all projects involving KPNC patients require a KPNC researcher to be involved, the CTP can provide consultation and collaboration support to:
- Researchers outside of KP who are looking for a KP collaborator on their project
- Research sponsors who would like to work with KP
- KPNC researchers who are looking for KP collaborators
Please submit a request through the Research Collaboration Portal (RCP) if you are interested in collaborating with us.
To initiate a Confidentiality Non-Disclosure Agreement (CDA) for an Industry-sponsored study, please e-mail: CTPCollaborate@kp.org
Policies and Procedures for Collaborating with KPNC
The following information will be helpful in planning, applying for and implementing collaborative research projects.
Before developing a proposal or submitting a joint application, collaborators should discuss and agree upon the following issues:
- Determine who will be the overall study Principal Investigator (PI)
- Delineate specific roles and expectations of team members
- Develop an adequate budget to cover all study-related costs
- Clarify data-related issues (e.g., access, storage, use, etc.)
- Determine authorship of study-related manuscripts
- Ensure appropriate confidentiality agreements are implemented
- Conduct any relevant activities preparatory to research using approved methods
The post-award responsibilities for PIs of funded projects consist of the following:
- Oversee all aspects of the project implementation, to ensure that the work is performed as detailed in the agreed-upon Scope of Work.
- Ensure that the project is reviewed at least annually by the IRB at both institutions or at only one institution if an agreement to cede authority was established.
- For clinical studies, ensure that all activities adhere to Good Clinical Practice guidelines and FDA Code of Federal Regulations (CFR) for FDA regulated trials.
- Ensure that adverse events are reported to the approving IRB as required.
- Ensure that spending is within budget and follows federal guidelines for allowable changes.
- If a subcontract PI, ensure that invoicing is accurate and timely for the project.
- Maintain frequent communication with your collaborator to ensure compliance with reporting requirements, financial monitoring, and other project management tasks.
- Ensure that all agreements are up to date, including: Subcontracts, Consulting Agreements, Data Use Agreements, and Material Transfer Agreements.
- Ensure that any transferred data are returned or destroyed at the end of the study as specified in the agreement.
Learn More about Clinical Trials and Clinical Research
To initiate a research project or to request research collaboration, research support or consultation from the CTP, submit a request via the Research Collaboration Portal (RCP).
To find regularly updated information on current IRB approved clinical trials or clinical research projects at Kaiser Permanente, visit KP Study Search.
