Clinical Research Coordinator Level 1 Programme

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Course Date
March 2023 Intake:	3 March 2023 to 21 April 2023 (Except 7 April)
September 2023 intake:	1 September 2023 to 13 October 2023
Every Friday, 9:00am to 6:00pm
Course Duration
Approximately 2 months / 7 weeks
Course Location
March 2023 Intake:	NTU@One-North (Buona Vista)
September 2023 Intake:	NTU@One-North (Buona Vista)
(Kindly note the course location may be subjected to changes.)
Registration Period
For every March Intake:	15 November to 15 January
For every September Intake:	15 June to 15 July

Course Description

- The Clinical Research Coordinator (CRC) is a specialised research professional working with the research investigator to ensure smooth progress of the research project. The CRC Level 1 Programme (Blended) is designed for CRCs with less than one year of experience and who are interested in gaining knowledge about coordinating clinical trials. The programme offers a comprehensive introduction to the operations of clinical trial at site and practical, hands-on training through the blended learning approach to provide flexible and effective learning. Participants will self-learn through the interactive study materials, followed by face-to-face (F2F) classroom sessions (physical or virtual) to reinforce the application of core CRC skills through classroom discussions, case scenarios, demonstrations and practice-based activities. This programme is also valuable for individuals seeking a new career as a CRC.
- The SCRI Academy was launched in August 2017 by the Senior Minister of State (Ministry of Health and Ministry of Transport) to house the training efforts for CRCs. The SCRI Academy is part of the Singapore Clinical Research Institution (SCRI), which is a business unit under the Consortium for Clinical Research and Innovation Singapore (CRIS), a wholly owned subsidiary of MOH Holdings.
- This training programme is funded by the Ministry of Health in collaboration with Health Sciences Authority, Singapore Health Services, National Healthcare Group, National University Health System, and Nanyang Polytechnic.

Learning Outcome

- - Describe the clinical trial activities from study initiation to closure
  - Discuss the importance of Good Clinical Practice
  - Understand the investigator and sponsor responsibilities in a clinical trial
  - Define the requirements for ethics submissions, source documentation and essential documents
  - Discuss the informed consent process
  - Discuss strategies for subject recruitment and retention
  - Prepare your site for a monitoring visit
  - Define safety reporting guidelines
  - Describe the process for management of investigational product at site

Who Should Attend

- - CRCs with less than one year of experience

Entry Requirements

- - At least a Diploma in Biomedical Sciences, Life Sciences, Nursing, Pharmacy or equivalent.
  - With current experience in CRC or equivalent duties

Course Outline

Week One

Programme Overview
Introduction to Clinical Trials*
Drug Development Process*
ICH Good Clinical Practice*
Clinical Trial Framework in Singapore*
Research Team
Elements of Protocol*
Protocol Feasibility
Study Budget
Billing and Payment to Sponsor
Clinical Trial Agreement
Site Start-up Activities and Workflow
Subject Screening
Randomisation and Unblinding
Essential Documents, Investigator Site File, Tools and Templates

Week Two (Full Day Class)

Overview of Singapore’s Healthcare System
Understanding Medical Records
Health Assessment by Observation
Administration of Medication
Specimen Collection
Documenting Real-time Progress Notes
Overview of Key Research Therapeutic Areas – Diseases and Investigations*
Common Medical Conditions and Related Medications*
Understanding Eligibility Criteria in Clinical Trials and Related Investigations*

Week Three

Central Laboratory Overview
Study Kits and Supplies
Collection of Biological Specimens, Processing and Shipping
Ethics Board and Application Process
Source Documentation
Safety Reporting to IRB
Protocol Deviations, Study Amendments and Reporting
Investigator Meeting and Site Initiation Visit*

Week Four

Subject Recruitment and Follow-up Documentation
Recruitment Strategies
Elements of Informed Consent Form
Informed Consent Process and Documentation
Safeguarding Vulnerable Populations
Wavier of Consent in Special Circumstances
Monitoring Visit Preparation and Follow-up*
Responding to CRF Queries*

Week Five

Regulatory Requirements of Clinical Trials
Clinical Trial Safety and Reporting Adverse Events to Regulatory Authorities
Clinical Trial Registry, PRISM
Overview of GCP Inspection
Common Inspection Findings
Notification of Serious Breaches

Week Six

Regulatory Requirements for Clinical Research Materials
Management and Handling of Investigational Product, and Documentation
Drug Dispensing and Accountability
Subject Visits, Follow-up and Retention
Subject Discontinuation
Payment to Subjects
Site Closure Activities
Early Termination of Study and Record Retention

Week Seven

MCQ Examination
Oral Assessment

* This is an e-learning module. If required, guidance and support will be provided by the trainers via email.

Please note that the above schedule may be subjected to changes.

E-Learning Session

Participants will be given access to the e-learning materials one month before and after the F2F classroom sessions. Participants are required to complete all e-learning videos and quizzes by Week 7 of the programme.

Technical Requirements

This is only applicable if the F2F classroom session is conducted virtually.

It is mandatory to fulfill ALL the following minimum technical requirements:

- 1. Use of PC or Laptop for MCQ Examination, as the system is not compatible on Mobile devices (e.g. mobile phone or tablets). You are also strongly encouraged to access the Zoom virtual class via a PC or Laptop for better learning experience as you need to refer to the training handouts while attending the class.
  2. Stable internet connection (3G or 4G/LTE), with minimum bandwidth of 600kbps is recommended. You can check your Internet bandwidth using www.speedtest.net or http://bandwidthplace.com/.
  3. Supported browser versions:
    - Windows: IE11+, Edge 12+, Firefox 27+, Chrome30+
    - Mac: Safari 7+, Firefox 27+, Chrome30+
    - Linux: Firefox 27+, Chrome 30+
  4. Headphone (preferred) or speaker to listen in (built-in / USB plug-in / wireless Bluetooth)
  5. Microphone for class discussion (built-in / USB plug-in / wireless Bluetooth)
  6. Webcam (built-in / USB plug-in). It is compulsory to turn on the camera for the duration of the Zoom virtual class for attendance authentication.

Application Procedure

To register for the CRC Level 1 Programme, applicants and their supervisors must complete the following electronic registration forms below.

Registration Form

[To be completed by Applicant]

https://for.sg/l1registration

Registration Form (Section C)

[To be completed by Supervisor / Reporting Officer]

https://for.sg/l1sectionc

Registration priority will be given to CRCs core-funded under the NMRC CRC programme. Priority will also be given to CRCs from Singapore’s public healthcare clusters under MOH Holdings.

Course Fees

Full Price	$3,100 (inclusive of 7% GST)
CRCs from Singapore’s Public Healthcare Clusters under MOH Holdings (After 90% subsidy)	$310 (inclusive of 7% GST)

Qualification

Participants who have completed all modules of the programme and have passed the examination will obtain:

- 1. E-Certificate of Participation (Essentials in Clinical Practice) from Nanyang Polytechnic,
  2. Certificate of Achievement (CRC Level 1 Programme) from SCRI Academy

For downloading of the programme brochure, please click here.

Enquiries

For enquiries, please contact scriacademy@scri.cris.sg.

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