Overview

Graduate Certificate Clinical Trials Design and Management

Offered through the College of Pharmacy Regulatory Affairs, the University of Georgia’s online Graduate Certificate in Clinical Trials Design and Management will prepare you to lead and manage the development and implementation of scientifically valid clinical study design including monitoring of clinical trials and directing daily clinical trial operations.

This interdisciplinary program encompasses critical core competency areas including biostatistics, federal regulations, bioethics, and project management. These areas are integral in drug product development and medical device design validation required for federal regulatory market clearance and commercialization.

The program plan is ideal for working professionals and consists of 17 semester credit hours, delivered online, with occasional face-to-face sessions at the UGA Gwinnett Campus. The certificate course work may be applied toward a Master’s Degree in Pharmacy with an emphasis in Regulatory Affairs.

Accreditations

The University of Georgia is accredited by the Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) to award baccalaureate, masters, specialist, and doctoral degrees. Contact the Commission on Colleges at 1866 Southern Lane, Decatur, Georgia 30033-4097, or call 404-679-4500 for questions about the accreditation of the University of Georgia.

College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE).

Technology Requirements

  • Computer with current operating system (Windows or Mac). Additional peripherals such as webcam, headphones and printer may be required.
  • High Speed Internet Access.

Cost

Tuition and Fees

Online Tuition $729 per credit hour 17 credit hours $12,393 USD
Student Fees $597 per semester 3 semesters $1,791 USD
Total Program Cost     $14,184 USD

If you register for less than 5 credit hours, student fees are reduced to $372 in that semester.

Tuition and fees are subject to change. Tuition is the same regardless of residency. Current tuition and fees are available on the Office of the Registrar website

Online students pay the following fees: Connect UGA, Green, Special Institutional, and Technology. See UGA Tuition and Fees for the complete schedule of fees.

Other Costs

Additional costs may include:

  • Textbooks
  • Exam proctoring fees
  • Technology upgrades 

Financial Aid

Visit the Office of Student Financial Aid for information about financial assistance.

Corporate Assistance

Consult your employer about the availability of tuition reimbursement or tuition assistance programs.

Military Assistance

Active duty military, veterans, and military families should visit Veterans Educational Benefits to take full advantage of available financial assistance and educational benefits.

University System of Georgia Tuition Assistance Program (TAP)

The purpose of TAP is to foster the professional growth and development of eligible employees. For more information, see Tuition Assistance (refer to the Distance Learning section). 

Admissions

Credit and Transfer

Total Hours Required to Earn Certificate:  17 (credit hours)
Maximum Hours Transferable into Program:  N/A

Admission Requirements

Students applying to The University of Georgia must be accepted by the Graduate School. Persons holding a bachelor's degree from any institution accredited by the proper regional accrediting association are eligible to apply for admission to the Graduate School. Preference will be given to applicants with a degree in sciences, healthcare, or engineering.  Preference will also be given to applicants employed in the pharmaceutical, medical device, biotechnology industries or related field.

Applying to the Certificate in Clinical Trials Design and Management Program is a two-step process. You will need to submit our departmental application and an application to the UGA Graduate School.

Students applying to the graduate school for non-degree status are not required to take entrance exams or to submit test scores and letters of recommendation. However, applicants are encouraged to include a company support letter in their application documents.

Non-Degree Application Checklist

  1. UGA Graduate School Application – Submit to the Graduate School online.  Application fee: $75 Domestic/$100 International.
  2. Certificate in Clinical Trials Design and Management Application (pdf) - Complete and Mail to the department:

Regulatory Affairs Graduate Education Program
The University of Georgia Gwinnett Campus
2530 Sever Road
Lawrenceville, Georgia 30043-4005

  1. Test Scores – International applicants must also submit TOEFL or IELTS scores.
  2. Statement of Purpose – Send to the department graduate coordinator. A statement of intent should clarify the candidate’s relevant background, interests, and goals, and indicate their intent for the online program in their statement.
  3. Résumé or curriculum vita – Send to the department graduate coordinator.
  4. Official Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission.

Application Deadlines

  • Fall:  June 1

International Applicants

  • Fall:  April 15

Curriculum

Program Structure

The program plan is ideal for working professionals and consists of 17 semester credit hours, delivered online, with occasional face-to-face sessions at the UGA Gwinnett Campus.

Course Sequence

Fall Term Spring Term Summer Term
  • Intro to the Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • Ethical Issues in Research (3 hrs)
  • Clinical Trials Design and Monitoring (4 hrs)
  • Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 hrs)
  • Project Management in Clinical Trials (3 hrs)

News & Events

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Alumna Profile: Kelly Winn's BioPharma Degree Was Along Her Natural Career Path

Kelly Winn recently graduated from the online M.S. in Pharmacy, BioPharma Regulatory Affairs program in December 2015, and has used her degree to propel herself along her natural career path where she works at the Georgia Institute of Technology. She started the degree up in January of 2014 with the intention of evolving her role as a regulatory compliance administrator into developing the first Regulatory Affairs program at Georgia Tech. 

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Over 30 of the University of Georgia's faculty and staff who teach online courses participated in a Quality Matters workshop last semester offered through UGA's Office of Online Learning. Quality Matters is a faculty-centered, peer review process intended to promote the design and development of quality online courses, and the Applying the Quality Matters Rubric workshop introduces course designers to these standards. 

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Engaging in Sustainable Online Course Development

The instructional design team at the Office of Online Learning takes pride in working with faculty to create online learning experiences that live up to the academic standards of the University of Georgia. We also consider how the environment we work in can support the continued offering of the courses we help develop. To this end, we encourage faculty to engage in sustainable course development practices for all online courses.

Financial Hardship Resources at UGA

The University of Georgia recently introduced a new website to deal specifically with financial hardship issues that arise in students' lives after they begin at UGA. 

Pages

Contact Information

Contact the online Clinical Trials Coordinator for answers to any additional questions you may have. 

Email us using the request for information form

or call