Introduction

Course Learning Objectives
This graduate diploma focuses on Research Method and Clinical Governance pertinent to the CRA role and requires the trainee to demonstrate that they are competent to:

• Apply privacy legislation and data protection in clinical trials
• Manage insurance and indemnification
• Manage pharmacovigilance activities
• Select appropriate research design for clinical trials
• Formulate research problems into empirically testable hypothesis
• Use medical statistics in clinical trial management
• Evaluate published research reports and apply to clinical practice
   

Duration of the programme:
Diploma in Clinical Research: *6 months; (11 modules)
Specialist Diploma in Clinical Research: 4 months; (7 modules)
Graduate Diploma in Clinical Research: 4 months; (7 modules)
Total: 14 Months, Part Time.

Course Module and Synopsis

1. Apply privacy legislation and data protection in clinical trials

In this module you will identify and appraise Privacy provision in Singapore, appraise Data Privacy in Clinical trials and identify and appraise Commercial Confidentiality in Clinical Trials.

2. Manage insurance and indemnification

In this module you will identify and appraise Insurance in Clinical Trials, identify and appraise Indemnification in Clinical Trials and evaluate the importance of insurance and indemnification in Clinical Trials.

3. Manage pharamacovigilance activities

In this module you will identify and appraise Pharmacovigilance process, monitor activities in relation to Pharmacovigilanc and describe roles and responsibilities in Pharmacovigilance process.

4. Select appropriate research design for clinical trials

In this module you will formulate a search for appropriate research design for clinical trials, conduct a search for appropriate research design for clinical trials and evaluate the literature on appropriate research design for clinical trials and document and apply this to practice.

5. Formulate research problems into empirically testable hypotheses

In this module you will formulate search for Formulating Research Problems into Empirically Testable Hypotheses, conduct search for Formulating Research Problems into Empirically Testable Hypotheses and evaluate the evidence gathered on Formulating Research Problems into Empirically Testable Hypotheses and document how this evidence is applied to Formulating Research Problems into Empirically Testable Hypotheses.

6. Use medical statistics in clinical trial management

In this module you will formulate Search for the Use of Medical Statistics in Clinical Trial Management, conduct search for the Use of Medical Statistics in Clinical Trial Management and evaluate the identified literature on the Use of Medical Statistics in Clinical Trial Management and document how these apply to the Clinical Research Industry.

7. Evaluate published research reports and apply to clinical practice

In this module you will formulate search for published research reports that apply to clinical practice, conduct search for published research reports that apply to clinical practice and evaluate the identified published research reports and document how these apply to clinical practice


Delivery Mode
All modules are delivered 80% online. 20% face-to-face over 3 days per month and then one day for assessment.

Course Commencement
Every month.

Assessment Methodology
Examinations, practicals, projects, assignments.

Graduation Requirements and Awards
To graduate, a student must complete and pass:

1. 11 modules to be awarded with WSQ Diploma in Clinical Research
2. 7 modules to be awarded with WSQ Specialist Diploma in Clinical Research
3. 7 modules to be awarded with WSQ Graduate Diploma in Clinical Research

Competency Assessment: Achievement of Statement of Attainment (SOA) after completion of every module.

Career Opportunities

• Biostatistician
• Clinical data analyst
• Clinical research associate
• Clinical team manager
• Laboratory scientist
• Project manager
• Quality assurance auditor
• Research fellow

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Entry Requirements

Entry Requirement

• Bachelor or equivalent in Life Sciences or relevant fileds.
• If you do not possess a degree or equivalent, your application will be considered on an individual basis dependent upon sufficient relevant work experience.

English Requirement

At least a C6 at GCE O/A Level English or equivalent or Academic IELTS 6.0 or equivalent; no element lower than 5.5 or equivalent

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Fees & Funding

Course Fees

$12000 (before GST)

Application Fee (Non-Refundable and non-transferrable)
Local student: S$50 (before GST)*

*Local student refers to Singaporeans/PRs/Employment Pass/Dependant pass holders

Course Fee
Local students: S$12,000 (before GST)

Insurance Fees

• Fee Protection Scheme***: Subject to prevailing market rate
• Medical Insurance Fee****: Subject to prevailing market rate

***The Fee Protection Scheme (FPS) serves to protect students’ paid fees.
****It is compulsory for all local and international students to purchase medical insurance which is valid throughout their course of studies with the CSM Academy International. Local students (Singaporeans, PRs & Non-student’s Pass holders) may opt-out for this scheme if they can provide the proof of adequate medical insurance coverage in Singapore.

Note:

• Payment of fees is in Singapore Dollars.
• Payment method only by Cheque/ Nets/ Telegraphic Transfer