Clinical Research Conduct and Management Professional Sequence Summer 2008

Clinical Research Conduct and Management

(EDP 402248)

About the Program

The human testing process known as the clinical trial is a key step in the drug development process. Regulations and guidelines govern clinical trials, and a thorough knowledge of procedures at every stage of the process is essential. The Professional Sequence in Clinical Research Conduct and Management provides broad knowledge of clinical trials, through coverage of FDA regulations, ICH GCP guidelines, practical procedural guidelines, and ethical considerations. The program prepares students for occupations as monitors, clinical research associates (CRAs), project managers, and study coordinators at biotechnology and pharmaceutical companies, contract research organizations, and investigational sites. Those already in the field will enhance their prospects for advancement.

Program Format

The professional sequence can be completed in two semesters (one year). It consists of four modules and three stand-alone courses. The modules must be taken in sequence. The stand-alone courses may be taken out of sequence. The program is offered in hybrid format in collaboration with ClinfoSource, and combines the convenience of online course access and the advantages of in-class meetings. Class meetings include lectures, discussions, exercises, and case studies. Any student is free to take individual courses rather than follow the complete program.

Access to Online Material

Students in the certificate program who register at least 10 days before the start of the class will be given access to the online material a week before the start of classes. All other students in the class will be given access to the online material no later than 3 business days after the first meeting of the class.

Who Should Attend

The program is for those considering a career in clinical research. It is recommended for those who are currently in allied areas in the biotechnology industry and wish to develop an understanding of clinical research and/or are considering a career change. The program is also intended for those who are new to the clinical research field.

Find Out More

The program was developed in collaboration with ClinfoSource.

Accreditation

All courses have been accredited by the California Board of Registered Nursing (BRN) to provide continuing education credit. Provider #00226.

Course Order and Prerequisites

The modules must be taken in sequence and some of the courses have prerequisites. Please read the course prerequisites before registering.

Required Courses

Module A: Introduction to Clinical Research X454 (2 units)

Clinical Trials: Phases and Design X440.6 (1 unit)

Module B: Clinical Trial Planning and Preparation X440.1 (2 units)

Project Management and Outsourcing X498.1 (1 unit)

Module C: Clinical Trial Initiation and Implementation X440.5 (2 units)

Data Management and Biostatistics X498.2 (1 unit)

Module D: Regulatory Reports and Audits X440.8 (2 units)

Medical Devices (under development)

Certificate Requirements

The modules and classes must be completed with a letter grade of C or higher to count toward a certificate of completion. The maximum time for the completion of the certificate is two years.

Registration Procedure

We recommend that you register for the professional sequence before you begin your second course in the program. To register, please (1) complete and submit the Program Registration Form or (2) print out and complete the form at www.unex.berkeley.edu/info/cert.php. Mail or fax it as it indicates, and include the nonrefundable registration fee. Professional sequence registration cannot be taken by phone.

Requirements may be updated based on new developments in the field of study; we recommend completing the program in a timely fashion.

Students in the certificate program who register at least 10 days before the start of the class will be given access to the online material a week before the start of classes. All other students in the class will be given access to the online material no later than 3 business days after the first meeting of the class.

The Professional Sequence in Clinical Research Conduct and Management is a hybrid program that consists of 50% classroom instruction and 50% online instruction. Listed below are the required courses for the certificate and the recommended order to complete them (determined by which term you begin with).

If you start the program in the fall semester:

Fall Semester	Spring Semester
1. Module A: Introduction to Clinical Research	4. Project Management and Outsourcing
2. Clinical Trials: Phases and Design	5. Module C: Clinical Trial Initiation and Implementation
3. Module B: Clinical Trial Planning and Preparation	6. Data Management and Biostatistics
	7. Module D: Regulatory Reports and Audits

If you start the program in the spring semester:

Spring Semester	Fall Semester
1. Module A: Introduction to Clinical Research	4. Project Management and Outsourcing
2. Clinical Trials: Phases and Design	5. Module C: Clinical Trial Initiation and Implementation
3. Module B: Clinical Trial Planning and Preparation	6. Data Management and Biostatistics
7. Module D: Regulatory Reports and Audits (This course is taken the following spring semester)

What We Offer

Streamlined one-year curriculum
UC Berkeley-approved courses
Evening and weekend class schedule. (Classes meet approximately every other Saturday, for two semesters.)
Online access to course materials
Hybrid format utilizing classroom instruction and the Web

Tentative Classroom Meeting Schedule

Meeting #	Date	Topic
Module A: Introduction to Clinical Research*
1	Feb. 9	Introduction to clinical research; Ethical considerations in clinical research
2	March 1	Principles of Good Clinical Practice (GCP); IRBs/IECs; Investigator responsibilities
3	March 15	Sponsor/vendor responsibilities; IND filing Module Exam
*Medical terminology module will be available online throughout Module A, but not discussed in class
Clinical Trials: Phases and Design
4	March 29	Drug Discovery and Development; Phases of Clinical Trials
5	April 12	Clinical Trials Design Exam
Module B: Clinical Trial Planning and Preparation
6	April 19	Protocol development; CRF design
7	May 3	Informed consent— elements and documentation; Informed consent— process and exceptions
8	May 17	Site selection; Pre-study visits; Site contracts and budgets Module Exam
Project Management and Outsourcing
9	Jan. 5	Project planning; Vendor selection
10	Jan. 26	Project management; Vendor management Exam
Module C: Clinical Trial Initiation and Implementation
11	Feb. 2	Regulatory documents overview and central files setup; Site initiation/ investigator meetings
12	Feb. 23	Subject recruitment and retention strategies; Global clinical trials
13	March 8	Routine monitoring; CRF review/source document verification; Study drug accountability
14	March 29	Safety reporting; Site/study close-out Module Exam
Data Management and Biostatistics
15	April 5	Data management
16a	April 12	Biostatistics and results interpretation
16b	April 19	Biostatistics and results Exam/Interpretation Project
Module D: Regulatory Reports and Audits
17	April 26	Clinical study report (CSR) writing; NDA filing
18	May 10	Sponsor/CRO: regulatory compliance and audits; Investigational site audits
19	May 31	Electronic records and signatures; Clinical trial SOP development; General Q&A on all topics; careers in clinical research discussion Module Exam

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