Clinical Trials Design and Management Certificate

Drugs, biologics and devices require structured clinical testing in humans prior to approval for marketing and post-marketing safety surveillance. This class provides an introduction to the clinical research industry including trends and opportunities, clinical program and trial development and management, regulations, ethics and the role of regulatory agencies, sponsors, investigators, IRBs and the public as study subjects or patients.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. (ICH E6(R2). This class will review the regulations (laws), guidance and best practices for drug, biologics and device research for the US and globally. We will focus on application of GCPs in sponsor companies and clinical research study sites from recruitment and consent of subjects to audit requirements. Fluency in GCPs is essential toward optimal employability, and will serve you well over the course of your career.

This course provides the foundation for monitoring clinical trials. Topics include roles and responsibilities of the sponsor and investigator site defined by the FDA and applied to monitoring activities from study start-up to completion. Study site selection, initiation, interim monitoring and closeout procedures are reviewed. Regulatory documents, source documents, safety reporting of adverse events, study drug accountability and compliance are reviewed. Principles of investigator grant budget, contract and payment are also reviewed.

This course will provide students with basic understanding of clinical trials design and will review techniques used to prevent potential bias that could impact the approval of a new drug to the market. Topics include Phase I to IV trials, project team roles, trial methodology and regulatory requirements. Processes and components of protocol development will include synopsis, hypothesis, scientific rationale, study objectives, sample size, endpoints, procedures, safety, ethical considerations and analyzing and reporting the results. Quality of life, pharmacoeconomics, management of clinical supplies and new technology will also be discussed.

Today's Clinical Trials depend on clean, fully integrated scientific databases, ready for statistical analysis and in full compliance with regulatory guidelines. This class teaches you to frame research questions accurately, in terms that work for the trial and for the database, to choose the most appropriate technology to capture and store the data, and to translate the data into terms understood by biostatisticians and the analysis programs most commonly used.

This course provides basic statistical concepts for the non-statistician involved in clinical trial design, implementation and report writing. Topics include the role of the statistician, statistical terms, study designs, sampling techniques, hypotheses, endpoints, data management and analysis plans.

The FDA and other regulatory agencies establish rules and guidelines for clinical development and marketing of medical products. This course provides an overview of the regulatory pathway necessary to gain approval to market medical products. Upon completion of this course, you will have a basic understanding of the regulations involved in clinical development and understand how manufacturing and preclinical/nonclinical areas interact with clinical development.

Collection, monitoring and evaluation of safety data is a key responsibility of the Sponsor and Investigator and the first goal listed by the FDA. Adverse events and serious adverse events are key data elements to review the safety of a product. An adverse event is defined as an untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. This course will introduce you to common safety monitoring practices and the regulatory reporting responsibilities for medical products.

Prerequisite: Introduction to the Clinical Trials Process; Good Clinical Practices

Hybrid (First day in the classroom, other classwork online) Each day a drug is delayed from reaching the market, the sponsor loses up to $8 million. Pharmaceutical, biotech and device companies are always looking to conduct clinical trials faster and more cost effectively. The Clinical Project Manager (CPM) is the main operations person leading the team charged with the day-to-day conduct of the clinical trial. This course examines how the CPM takes a clinical protocol and moves it through the start-up and conduct stages of a clinical trial. We will review several key processes including vendor selection, establishing study processes, selection and training of clinical investigator sites, regulatory and IRB submissions, management of drug supply, enrollment, data entry and monitoring to name a few.

Prerequisite: Clinical Project Management I

Hybrid (First day in the classroom, other classwork online) Each day a drug is delayed from reaching the market, the sponsor loses up to $8 million. Pharmaceutical, biotech and device companies are always looking to conduct clinical trials faster and more cost effectively. The Clinical Project Manager (CPM) is the main operations person leading the team charged with the day-to-day conduct of the clinical trial. This course examines how the CPM works through the study close-out stage of a clinical trial. We will review how the team moves through he final data collection and cleaning processes, database lock, analysis, support for closing down clinical investigator sites and vendors and development of the clinical study report.

Case Report Form Design

The case report form (CRF) is the primary data collection tool in clinical trial conduct, analysis and reporting of results. The sponsor is responsible for development of a CRF that accurately represents the protocol, management of CRF production, monitoring and auditing. The study site is responsible for accurate and timely completion of the CRF. This short course provides an overview of key elements in design and management of the CRF.

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Compliance Audits/FDA Inspections

Regulatory authorities may conduct routine or for-cause inspections of sponsor and study sites during clinical trials and routine inspections prior to product approval. This is an overview of FDA and sponsor audit procedures, roles, processes and responses to findings.

For SF State Login and registration questions, please contact Enrollment Services at (415) 405-7700.

All classes are held online. Required courses are generally offered two to three times a year. Electives are held once or twice a year, as necessary. Once you have registered and paid for classes, you may log in to iLearn using your SF State Login & Password.

To ensure you have access to the course before the first class meeting, please enroll at least THREE weeks before the start date. Payment is due upon registration.

Some classes have been approved for contact hours by the California Board of Registered Nursing. California BRN Provider #CEP15289. Certificate of contact hours will be retained for a period of four years after the course concludes.

Once you have completed the necessary coursework, submit the Certificate of Completion Request Form.