WSQ Diploma in Clinical Research (CSM Academy International)

Language requirements:

At least a C6 at GCE O/A Level English or equivalent or Academic IELTS 6.0 and above or equivalent.

Academic requirements:

Bachelor or equivalent in Life Sciences or relevant fields.

• Clinical Trials
• Research & Development
• Multi-centre & Global Trials
• Phase I, II, III and IV drug trials
• Pharmaceutical Industries
• Therapeutics, Diagnostics, Theranostics
• Pharmacogenomics and Pharmacokinetics & Pharmacodynamics (PK/PD studies)
• Drug Formulations, Nutrition & Dietetics
• Neutraceuticals
• Drug Delivery & Drug Development
• Clinical Trial Hub – Singapore (All Drug Trial regulations are in place)
• Asia will have about 40-45% of Global Drug Trials.

Career Path

• Clinical Research Associate (CRA) or
• Clinical Research Coordinator
• Clinical Trial Supervisor
• Trial Manager
• Sr Manager / Country Manager
• Asst Director
• Deputy Director
• Director (for example – Asia pacific)
• Global Director

Clinical research also considers the ethical issues that could arise from their implementation for prevention, treatment, diagnosis or for relieving symptoms of a disease.

The Clinical Research Programmes offered are:

• WSQ Diploma
• WSQ Specialist Diploma
• WSQ Graduate Diploma

It’s the first of its kind in the clinical research industry. Endorsed and validated by the industry. Each diploma equips the students with practical knowledge and competency-based skills to prepare them for a career in the field of Clinical Research.

Apply the principles of pharmacology in clinical research (Synchronous & Asynchronous e-learning)

In this module, you will recognise the basic pharmacological principles in clinical trials, apply basic pharmacology in clinical trials and monitor the clinical research process to ensure that the correct pharmacological principles are used.

Apply ethical theories to trial design (Synchronous & Asynchronous e-learning)

In this module, you will identify and appraise the vital ethical theories that are employed within clinical research critically, determine the fundamental ethical principles that should be adhered to within clinical trial design to assure the safety of patients, verify that the moral laws are followed in clinical trials and document all non-compliance in accordance to organisational procedure.

Manage lab related matters in clinical research (Synchronous & Asynchronous e-learning)

In this module, you will identify the different laboratory-related matters, interpret Laboratory results in clinical trials, apply principles of toxicity in clinical trials and calculate the correct drug dosage and IV flow rate using given formula.

Use of Biostatistics in Clinical Research (Synchronous & Asynchronous e-learning)

In this module, you will identify and appraise the pertinent literature surrounding biostatistics in clinical trials, discuss the biostatistical approaches applied in the clinical research process, determine if the correct biostatistical method is being used in the clinical research process and document all non-compliance in accordance to organisational procedure.

Interpret product life cycle and its influence on the clinical trials industry (Synchronous & Asynchronous e-learning)

In this module, you will identify the phases of the product life cycle, describe the relationship between clinical trials and product life cycle, identify the relationship between the product life cycle and the clinical trial and document how clinical trial industry audit the product life cycle.

Review of clinical development and drug development in clinical research (Synchronous & Asynchronous e-learning)

In this module, you will identify and appraise the phases of drug development in clinical trials, identify and appraise the stages of clinical development in clinical trials and describe the association between clinical development and drug development.

Apply Good Clinical Practices in Clinical Research (Synchronous & Asynchronous e-learning)

In this module, you will apply international principles of ethical conduct and subject protection, apply proper clinical practices guidelines (International Conference on Harmonisation (ICH), Food and Drug Administration (FDA), Singapore Good Clinical Practice (SG GCP) and European Union (EU) Clinical trials directive), apply European Union – Good Manufacturing Practice (EU-GMP) in Clinical Trials and differentiate FDA Regulations from EU Regulations.

Manage documentation in clinical research (Synchronous and Asynchronous e-learning)

In this module, you will handle documents in the clinical trials settings, perform efficient filing in clinical trial management and ascertain that the report is being handled by regulatory guidelines.

Monitor progress in clinical trials (Synchronous and Asynchronous e-learning)

In this module, you will learn to perform specific tasks in monitoring clinical trials, manage the clinical trial site using a monitoring tool, perform data monitoring in clinical trials, manage the electronic data capture (EDC) and interpret electronic source data in clinical trials.

Initiate a Clinical Trial

In this module, you will learn to prepare a research proposal in clinical trial management manage contract negotiation for clinical trials and adhere to safety regulations during reporting in a clinical trial.

Manage Clinical Research Trials

In this module, you will manage Clinical Trials, manage data management issues, report adverse events, perform drug accountability and track corrective and preventative actions.

Assessment Methodology

Practical Assessments and/or Summative Assessments

In case students fail the main examination of a particular module, they are allowed to sit for ‘One’ supplement assessment with payment of the appropriate fee*.

Students are to re-take the module, shall they fail the supplementary assessment. Modules are independent of each other.

* Refer to the Miscellaneous Fees