Clinical Trials Design & Management: Certificates

Clinical Trials Design & Management Curriculum

Take all required classes (17.4 CEU, or 174 hours) to complete the certificate.
First two classes in italics are prerequisites to all other classes.

Subject/
Course #
Required Course CEU
IT 9357
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.
1.8
IT 9358
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.
1.8
IT 9387
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.
1.8
IT 9388
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.
1.8
IT 9359
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.
1.8
IT 9386
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.
1.8
IT 9531
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.
1.2
IT 9539
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.
1.2
IT 9351
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.
1.8
IT 9354
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.
1.8
IT 9392 OR
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.
 

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.
.6

Clinical Development Fundamentals Curriculum

Take seven required classes (10.2 CEU, or 102 hours) to complete the certificate.
First two classes in italics are prerequisites to all other classes.

Subject/
Course #
Required Course CEU
IT 9357
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.
1.8
IT 9358
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.
1.8
IT 9388
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.
1.8
IT 9531
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.
1.2
IT 9543
Prerequisite: Overview of Drug/Biologic Development, or Overview of Device Development
This course will introduce you to the concepts and requirements necessary for compliance with current Good Manufacturing Practice (cGMP) for pharmaceuticals and biopharmaceuticals. This course will prepare you to establish and document a system of GMP controls required to manufacture drug products in the United States, the European Union, Japan and many parts of the world.
1.2
IT 9542
Prerequisite: Overview of Drug/Biologic Development, or Overview of Device Development
This course will introduce you to the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP). This course will help prepare you to establish and document a system of GLP controls required to test medical products where data is intended for inclusion into a regulatory filing in the United States, the European Union, Japan and in many parts of the world.
1.2
IT 9539
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.
1.2

How to Begin Taking Classes

  • There is no application process to begin taking classes.
  • Obtain SF State ID and Password.
  • Register for classes based on individual goals and prerequisites.
  • Payment is due upon registration. Space is limited. Please register three weeks in advance.
  • Apply for Certificate after all classes have been successfully completed.
  • Log in to iLearn using your SF State ID and Password.

For SF State ID and registration questions, please contact Enrollment Services at 415.405.7700; press '5' to speak with a staff person.

Clinical Trials Design & Management Certificates of Completion

Students may take individual courses based on experience and professional goals. An understanding of Medical Terminology is recommended. We will offer the one-day medical terminology class at least twice a year for those students without the medical background. (This does not count toward the certificate.)

Candidates for each certificate must complete all required courses (17.4 CEUs for Clinical Trials Design & Management, or 10.2 CEU for Clinical Development Fundamentals) in the curriculum. Once a candidate has completed the necessary coursework, an application for the Certificate of Completion must be submitted. Applications are due, along with a $50 non-refundable fee and unofficial SF State transcripts, showing successful completion of all necessary classes.

Intended Audience

Individuals who pursue a Clinical Trials Design & Management, or Clinical Development Fundamentals certificate from SF State Extended Learning are professionals, often with advanced degrees, working in science, health care, technology, or management.

Length & Cost of Program

The time it takes for participants to finish the certificate of completion varies according to students' availability and experience. The 17.4-CEU Certificate of Completion (174 hours) may be accomplished in as short a time as three semesters, or students may take as long as needed, up to three years.

The cost of the program is calculated on a per-class basis. Class tuition is available online at our website with each course description. Prices may vary each semester. There are no additional costs for course materials, except a certificate fee of $50.

The cost of the certificates of completion are $2,725 for Clinical Development Fundamentals, and $4,465 for Clinical Trials Design & Management.

Location & Frequency of Classes

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 ID and Password.

Please Register Early!

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.

Board of Registered Nursing (BRN)

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.

CalJOBS

As a result of the Workforce Innovation and Opportunity Act (WIOA) of 2014, CalJOBS provides connections to customer-focused employment training for adults and dislocated workers. SF State is an approved provider for WIOA funds. SF State is listed on the Eligible Training Provider List (ETPL) on the CalJOBS website. Search on Keyword: SF State.

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