Investigators

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.

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.

The Central Business Office typically reviews, completes, and approves all negotiations with the sponsor within 60-90 business days from receipt of draft contract, budget, and final/latest protocol. This is done concurrently with the IRB approval process.

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

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).

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

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.

Principal investigators and study site staff will work with sponsors to facilitate monitoring and auditing processes. Monitors and auditors acting under the confidentiality and contractual agreement of the clinical trial can be provided “Read Only” access to view source documentation for enrolled subjects while on site at a Kaiser Permanente facility.

Yes. Each of our medical centers has one or more fully staffed pharmacies. Both the principal investigator and the sponsor must agree on the involvement of any of our pharmacies. The principal investigator and research team will work directly with the local pharmacy operations based on protocol needs, which may include secure space to receive, inventory, and dispense the investigational drug.

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.

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.