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Clinical Trials Administration Office (CTAO)
Clinical Trials conducted at UCLA under an industry-developed protocol or an investigator-developed protocol must have a contract in place with the industry sponsor. As soon as a Principal Investigator "PI" has decided to participate in a study the PI should submit the required paperwork to the CTAO. The CTAO negotiates all of these contracts. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, under Phase I, II, III, or IV, although they can be designed with the sole purpose of collecting and analyzing data about approved drugs or devices in order to contribute to medical knowledge about the treatment of a disease or medical condition. Financial support for a clinical trial must be provided by a private entity, including pharmaceutical companies, interest groups, or charities. In all cases, the study must include the prospective enrollment of human subjects and the controlled testing of a drug, device, or diagnostic under an approved protocol.
- Contact the CTAO: The CTAO’s For Faculty/Staff web pages are for INTERNAL USE ONLY and access is restricted to UCLA employees. To obtain log-in credentials to access these pages, please contact the Clinical Trials Administration Office at 310-794-8322 or email@example.com
- Coverage Analysis Required: Additionally, Effective July 15, 2012, UCLA Policy 915 requires that all clinical trials complete the Coverage Analysis Process. This analysis identifies all costs that may be billed to insurance or third party payers and must be in alignment with the information in the informed consent documents. For further information, please visit the For Faculty/Staff section of the site.
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Clinical Research Management Forms and Tools
The forms and checklist below are designed to assist in the conduct and management of clinical research. The forms and checklist can be used as guidance for setting up clinical research studies and conducting periodic self-quality assurance reviews.
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Preparing for an FDA Clinical Investigator Inspection
For routine inspections expect to receive an FDA pre-announced inspection phone call from one to three days in advance of the visit.
- Notify the UCLA OHRPP. For consultation and guidance, call Marcia Malmet, RN at 310-983-3150.
- If the FDA will be inspecting a drug study(s), notify the UCLA Department of Pharmaceutical Services, Investigational Drug Section at 310-267-8522.
- Have available:
- All study documents (except financial/internal audits). You may need to obtain these from offsite storage.
- Staff/persons knowledgeable about the study
- Make arrangements to provide space where the inspection will take place (desk, chair, access to photocopier)
- Set time aside for the duration of the inspection: typically 3-7 days.
- Review the FDA guidance document: FDA Inspections of Clinical Investigators
For directed or for-cause inspections you may receive a one-day notice or the inspectors may arrive unannounced.
- Follow the same directions as above
- The visit will last as long as needed
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Websites with Information about Clinical Trials
In addition to referring to the UCLA OHRPP website, the following websites will assist you in understanding and correctly applying the many regulations and policies regarding research with human subjects:
HHS Office for Human Research Protections (OHRP)
Provides assurances and IRB registration, education, policy guidance, and workshops.
||U.S. Food and Drug Administration (FDA)
Provides FDA regulations and guidance on the conduct of clinical trials. Also, provides links to FDA documents relating to human drugs, vaccines, other biologics, blood products and medical devices.
- FDA Forms & Submission requirements for Investigational New Drugs (IND), New Drug Applications (NDA), Abbreviated New Drug Application (NDA), Orphan Drug Products, and Electronic Regulatory Submission and Review (ERSR)
- Running Clinical Trials: FDA Guidances, Information Sheets, and Notices provide information about adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP).
- FDA Device Advice: Device Regulation & Guidance provides comprehensive regulatory assistance for devices.
- FDA Office of Good Clinical Practice (GCP) is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA.
- Center for Drug Evaluation and Research performs essential public health tasks by making sure that safe and effective drugs are available to improve the public health of the people in the United States.
- FDA Warning Letters, Inspections, Compliance, Enforcement and Criminal Investigations: Warning letters are issued for violations of regulatory significance and made available to the public on its website. It is the FDA’s practice to give individuals the opportunity to take voluntary and prompt action before it initiates the enforcement action. Warning letters are issued to achieve voluntary compliance and to establish prior notice.
The Society of Clinical Research Associates, Inc.
A non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.
The Association of Clinical Research Professionals (ACRP)
The primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.
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We are interested in your feedback and welcome your suggestions. Send us your comments and let us know what training and information you would like us to provide. Contact us at OHRPPEQI@research.ucla.edu.
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Page Last Updated: December 16, 2014