Specialist Diploma in Clinical Research Management

The Specialist Diploma in Clinical Research Management aims to develop competent clinical trials professionals. This course will equip them with in-depth knowledge on healthcare trends and legislation and skills that will allow them to respond effectively in a rapidly changing healthcare arena.

What You'll Study

Post-Diploma Certificate in Clinical Research Principles

Module 1: Drug Development Process [30 hours]

Drug development process is essential for learners to understand the process of bringing a new pharmaceutical drug to the market once a potential chemical compound has been identified through the process of drug discovery. Learners will learn step-by-step approach in stages of drug development, starting from the discovery of a new chemical entity through pre-clinical safety, efficacy and toxicology testing with emphasis on the definition, purposes and challenges faced in preclinical studies. Learners will also gain an insight to the route of clinical testing and phases of clinical trials before a potential medicine makes its way to pharmaceutical manufacturing. Learners will be able to visualize the final stage of drug development in the perspective of market launch of new medicine and post marketing surveillance.

Module 2: Clinical Research Ethics [30 hours]

Clinical research ethics is the code of conduct that guides the values and behaviors of a clinical research professional to achieve ethical research practice. Learners will acquire the fundamental legal and moral principle relating to clinical research. Learners will learn to interpret and apply the principles of biomedical ethics and legal obligations in an appropriate manner to protect the rights and welfare of human research participants. Learners will also have a good grasp of the types of regulatory guidelines in clinical research.

Module 3: Clinical Research Project and Methodology [45 hours]

Good clinical research proposals require astute application of clinical research project and methodology. Learners will have a good grasp of the various research skills such as selecting literature review research design, performing data collection and data interpretation. Learners will also acquire the skills in applying the principles of scientific inquiry, identify sampling techniques and formulating research questions for their research proposal.

Module 4: Good Clinical Practice in Clinical Research [30 hours]

Good Clinical Practice (GCP) in clinical research is the guiding principles for conducting clinical research. Compliance with GCP provides public assurance that the rights, safety, and well-being of research subjects are protected, and clinical research data are credible. Learners will familiarize with the international GCP guidelines as established by global regulatory authorities. Learners will be proficient with the GCP requirements by gaining an insight on the roles and responsibilities of study investigators, ethics committee and sponsors. Learners will be equipped with the best practices and approaches to implementing GCP guidelines for various processes of clinical research and their applications to clinical research.

Post-Diploma Certificate in Clinical Research Management

Module 1: Principles of Clinical Research Management [45 hours]

Effective management of pre-study activities is crucial for a successful clinical study. Using interactive exercises, learners will acquire the knacks of protocols and case report forms development, as well as the requirement for regulatory document submissions. Learners will also grasp the practical aspects of planning and preparing for pre-study site visits, drafting of site contracts and budget development for clinical research.

Module 2: Clinical Research Operation [45 hours]

The foundational knowledge of principles of clinical research management allows for the progression into clinical research operation where the focus is on various operational activities during a clinical study. Learners will be equipped with the strategies for subject recruitment and retention, as well as preparing for routine site monitoring and clinical audit. Learners will also adopt specific monitoring processes for timeline planning and daily operation of clinical research.

Module 3: Patient Oriented Skills in Clinical Research [30 hours]

Performing patient assessments are essential for a clinical research professional. Patient Oriented Skills in Clinical Research equip learners with skills for patient assessment that are pertinent for the conduct of clinical research. Learners will acquire the skills in performing Basic Cardiac Life Support (BCLS) and first aid which are essential for protection of research participants.

Certification

Participants who meet the assessment and attendance requirements of four modules under the each post-diploma cert (PDC) will be awarded the respective PDC.

Participants will be awarded the Specialist Diploma in Clinical Research Management upon successful completion of 2 PDCs. The award of the Specialist Diploma is governed by the Polytechnic’s examinations rules and regulations.

Specialist Diploma in Clinical Research Management

What You'll Study

Module 1: Drug Development Process [30 hours]

Module 2: Clinical Research Ethics [30 hours]

Module 3: Clinical Research Project and Methodology [45 hours]

Module 4: Good Clinical Practice in Clinical Research [30 hours]

Module 1: Principles of Clinical Research Management [45 hours]

Module 2: Clinical Research Operation [45 hours]

Module 3: Patient Oriented Skills in Clinical Research [30 hours]

Certification

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Specialist Diploma in Clinical Research Management

Module 1: Drug Development Process [30 hours]

Module 2: Clinical Research Ethics [30 hours]

Module 3: Clinical Research Project and Methodology [45 hours]

Module 4: Good Clinical Practice in Clinical Research [30 hours]

Module 1: Principles of Clinical Research Management [45 hours]

Module 2: Clinical Research Operation [45 hours]

Module 3: Patient Oriented Skills in Clinical Research [30 hours]

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