WSQ Diploma in Clinical Research

The WSQ Diploma in Clinical Research provides the trainees with an excellent basic to progress their studies.

About Singapore Workforce Skills Qualifications (WSQ)

The Singapore Workforce Skills Qualifications (WSQ) is a national credentialing system. It trains, develops, assesses and recognises individuals for the key competencies that companies look for in potential employees.
WSQ is based on national standards developed by WDA in collaboration with various industries comprising industry sectoral frameworks which serve to:

  • Professionalise the industry, particularly where recognition of Continuing Education and Training (CET) qualifications are lacking
  • Improve labour mobility allowing companies in growing industries to easily recruit workers with the necessary skills whilst improving opportunities for workers to enter these industries.

The WSQ system is designed to be a practical, accessible and affordable launching pad for individuals to take charge of their own careers and advancement. It is also a powerful business tool for employers to access and maintain a skilled workforce as it enhances their competitive edge and advancing their businesses.

FAQS

 

Course Duration

For local students: 6 months. (Part time)
(3 hour lesson/day, 1 day/week)

Course Structure

There are a total of 11 modules on WSQ Diploma in Clinical Research.

Course Module and Synopsis

1. Manage documentation in Clinical Research

In this module you will handle documents in the clinical trials settings, perform efficient filing in clinical trial management and ascertain that the document are being handled in accordance with regulatory guidelines.

2. Monitor progress in Clinical Trials

In this module you will learn to perform specific tasks in monitoring clinical trials, manage clinical Trial Site using Monitoring tool, perform Data Monitoring in Clinical Trials, manage the electronic data capture (EDC) and interpret Electronic Source Data in Clinical Trials.

3. Apply principles of pharmacology in clinical research

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.

4. Manage Lab related matters in Clinical Research

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.

5. Apply ethical theories to trial design

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

6. Use of biostatistics in clinical research

In this module you will identify and appraise the pertinent literature surrounding biostatistics in clinical trials, discuss the biostatical approaches applied in the clinical research process, determine if the correct biostatical approach is being use in clinical research process and document all non compliance in accordance to organizational procedure.

7. Interpret Clinical Development & product life cycle in Clinical Research

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.

8. Application of Clinical Trial in Drug development process

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

9. Apply good clinical practices in Clinical Research

In this module you will apply international principles of ethical conduct and subject protection, apply good 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.

10. 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

In addition to these modules you will also undertake a work-based learning module, a Research methods module, an option module and, finally, a dissertation relating to Clinical Research.

11. 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.

Course Learning Objectives

This Diploma focuses on the Practical aspects, Legislative/Regulatory components and theoretical underpinnings of the CRA (Clinical Research Associate) role and required the trainees to demonstrate that they are competent to:

  • Manage documentation in Clinical Research
  • Monitor progress in clinical trials
  • Apply the principles of pharmacology in clinical research
  • Manage lab related matters in clinical research
  • Apply ethical theories to trial design
  • Use of biostatistics in clinical research
  • Interpret product life cycle and its influence on the clinical trials industry
  • Review of clinical development and drug development in clinical research
  • Apply good clinical practices in clinical research
  • Manage clinical research trials
  • Initiate a clinical trial

Delivery Mode

The Practice module is delivered face-to-face over alternate weeks and then one day for assessment. This Diploma also compromises of online study and required to meet minimum number of hours.

Course Commencement

Every Month.

Assessment Methodology

Assessments/Exams are conducted after every module.

Examinations, practicals, projects, assignments.

Graduation Requirements and Awards

Graduation Requirements and Awards

To graduate, a student must complete and pass a total of 11 modules to be awarded the WSQ Diploma in Clinical Research.

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

Career Opportunities

  • Clinical research associate
  • Research fellow

Entry Requirement

  • Bachelor or equivalent in Life Sciences or relevant fields.
  • 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 overall band of 6.0 with no element scores lower than 5.5 or equivalent.

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

Local students

Step 1 – Fill up the following online forms:

  • Application Form – CSM Academy International Pte Ltd

Step 2 – Attached the following documents:

  • A copy of passport-size photographs with white background
  • A copy of passport (must have at least 1 year validity for foreigners with valid pass) / NRIC (For Singaporean / PRs)
  • Notarised/Certified true copies of all your educational transcripts and completion certificates
  • Proof of English Proficiency; either IELTS/TOEFL score sheet or equivalent qualification (if applicable)
  • A copy of resume
  • Application fee (non-transferable and non-refundable):
  • Payment mode:
    • Via Paypal
    • Via Demand Draft / Cheque payable to “CSM Academy International Pte Ltd”; or by Telegraphic Transfer:
      • Account Name: CSM Academy International Pte Ltd
      • Company Address: 250 Sims Avenue #03-01 SPCS Building Singapore 387513
      • Account Number: 3183003044
      • Bank Name: United Overseas Bank Limited
      • Bank Address: Tanjong Pagar Blk 1 Tanjong Pagar Plaza #01-37/40 Singapore 082001
      • Bank Code: 7375
      • Branch Code: 009
    • Note:All documents must certified true copies of the original documents. If documents are not in English, official translations must be included.
      Please ensure that your application forms and documents reach us at least 2 months before course commencement.

Step 3 – Acceptance by the School
Upon receipt of your completed application, you will be notified of the outcome of your application within 2 weeks. Successful applicants will receive Letter of Acceptance via email and mail out the original copy to applicants.

Step 4: Offer Acceptance
If you decide to accept the offer, you will need to sign the Letter of Acceptance via email/post.

Step 5: Payment of Programme Fees
Upon receipt of your signed Letter of Acceptance, you will be required to bring the original certificates for verification and to sign the student contract and follow by course fee payment.

Resources

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