Clinical Trials Division
The Department of Research & Evaluation Clinical Trials Division promotes research that focuses on advancing the practice of medical care to improve health outcomes. Kaiser Permanente Southern California clinician investigators are practicing physicians who bridge the gap between research and clinical practice. Typically, research in Kaiser Permanente is aimed at evaluating the impact at the bedside and using this perspective to conduct studies that answer meaningful and clinically relevant questions.
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The following information provides guidance in the conduct of clinical trials for investigators and sponsors.
- Key Steps for Conducting Clinical Trials
- Investigator Initiated Clinical Trial Protocol Template
Clinical Trial Newsletters & Annual Reports
- Current and Previous Newsletters and Annual Reports
Working with Outside Academic Partners
- Working with Outside Academic Partners
Training & Education
- Research Personnel Training Attestation Form
- Collaborative Institutional Training Initiative (CITI) Good Clinical practices Training - (An Orientation for KP Researchers)
Standard Operating Procedures (SOPs)
Append B - New Record Retention Memo
- Participant Letter: Re-Consent (Mail Only)
- Participant Letter: Re-Consent. Spanish vs (Mail Only)
- Participant Letter: Unable to Contact (Certified Mail)
- Quality: CT Site Report
- Quality: Elements of a Site Plan
- Quality: Research Site Plan
- Quality: Sample PI Quarterly Report
- Quality Tool: ICF Verification
- Quality Tool: Regulatory File Review
- Quality Tool: Chart Review
- Temperature Pharmacy Record - Ambient
- Temperature Pharmacy Record - Refrigerated
- Trial Registration at Clinicaltrials.gov Website
- Archiving Process
Please contact Nydia Soler, RAIII @ Nydia.M.Soler@kp.org
KP HealthConnect® Tools for CT
KP HealthConnect instructions for monitor access
- KP HealthConnect Chart Review Access Form
- KP HealthConnect Training Attestation for Monitors
- Request to add study drug to KP HealthConnect
- KP HealthConnect (http://kpnet.kp.org/kphealthconnect/)
- How to create research episodes
- KP HealthConnect Part 11 Compliance Memo
iRIS Tools for CT
iRIS CT and IRB FAQ Version 3
- Attachment A - 21 CFR Part 11 Compliance Memo for iRIS™
- Attachment B - Clinical Trials Guide: CV and Training Account - Profile Update Instructions in iRIS™
- Attachment C - iRIS CT Signoff Instructions
- Attachment D - CT Guide Delegation of Submission Signoff in iRIS
- Attachment E - CT Guide IRB Pre-review Process
- Attachment F - CT Guide Revising An IRB-approved ICF
- Department of Research & Evaluation Finance
- Budget Checklist
Institutional Biosafety Committee (IBC)
- Key Steps for PI's
- Kaiser Permanente Southern California (KPSC)BioSafety Procedures
- IBC Review Process
- Laboratory BioSafety
- IBC Contact List
- Instructions for completing the IBC registration form for Recombinant DNA and/or Infectious Agents
- Request for IBC Protocol Modification
- Kaiser Permanente Southern California (KPSC) Biosafety Committee Annual Review Report
- Gene Therapy Clinical Trials
- NIH Biotechnology
- Appendix M
Articles of Interest
- Clinical Trials Budgets
- Supervisory Responsibilities of Principal Investigators
- The Clinician as Investigator
- Reforming the Regulations Governing Research with Human Subjects
Clinical Trial Services
The SCPCT has completed numerous clinical trials. These have been funded by government, industry, and foundations, and have encompassed not only most therapeutic areas but also the areas of health policy, economics, statistics, and quality of life.
The Clinical Trials services coordinates and facilitates ACCESS, QUALITY and EFFICIENCIES through
- Sponsor and Contract Research Organization (CRO) contacts.
- Institutional Review Board application support.
- Budget Development and contract negotiations.
- Site initiation and management.
- Regulatory support.
- Quality and compliance review.
- Clinical Trials staff research training and tracking.
- Personnel recruitment support.
What do our Scientific Leaders do?
- Develop ideas and protocols for new clinical research projects.
- Act as principal investigators for SCPCT projects.
- Make scientific presentations at professional meetings.
- Author manuscripts for peer-reviewed journals.
- Mentor fellows and medical students.
- 24-hour coverage via pager.
- Provide expert support for clinical program development plans and FDA and international regulatory meetings.
The Regulatory Services department was officially formed at SCPCT in June, 2002. Capabilities of this group include
- Regulatory resource for SCPCT investigators.
- Filing and maintenance of investigator-initiated INDs/IDEs.
- Protocol review.
- New project consultation.
The comprehensive services of the SCPCT include site management and clinical monitoring capabilities. SCPCT Site Management offers the following capabilities
- Investigator qualification/selection and site recruitment.
- Investigative site start-up and training.
- Facilitation of clinical trial enrollment.
- Ensuring site regulatory compliance.
- CRF completion, data collection and query resolution.
- Expedited adverse-event reporting.
Southern California Permanente Clinical Trials has extensive experience collaborating with federal, academic and industry sponsors.
In summary, SCPCT scientific leaders are uniquely positioned to understand and implement numerous project designs.
Clinical Trials Team
The Southern California Permanente Clinical Trials Research Program promotes research that focuses on advancing the practice of medical care to improve health outcomes.
If you are interested in more information about our services, feel free to contact:
(626) 564-5667; tie: 8-338-5667
100 S. Los Robles Ave, Pasadena, 91101