The Beginning – A CRC’s Guide to Clinical Research Management

Overview

A beginner's course that equips entry-level Clinical Research Coordinators (CRCs) with the necessary know-hows, competencies and skills to perform and support clinical research studies. Participants will gain insights on how to manage a study from initiation to close out including the roles and responsibilities of a CRC; management of investigational products and biological samples; how to prepare for a monitoring visit and more.

This course is part of the cluster CRC training series brought to you by SingHealth Clinical Trials Coordinating Centre (CTCC).

Learning Objectives

Training will be delivered in 3 parts:

Part 1: eLearning modules

Human Biological Research Act (HBRA) Essentials
IRB 101 - Overview of CIRB and iShare Submission
Drug Development
History of Research Ethics
PI and Sponsor's Responsibilities in Clinical Research Studies
Responsibilities of a CRC During the Pre-Study Phase
Responsibilities of a CRC During Study and Post Study
What to take note of in a protocol
Protecting Subject Confidentiality
Essential documents
Management of Biological Samples
Maintenance of Investigational Site File
Fraud and Misconduct
Safety Reporting
Investigational Product (IP) Accountability and Storage
Preparing for Monitoring Visit
Audit and Inspection
Overview of Clinical Trial Insurance
How to Manage Research Patients
User Guide for SCM CTR Research Note

Part 2: Webinar lectures

Regulatory Requirements for Clinical Trials
Informed Consent Process and Documentation
HBRA Consent

Part 3: Online quiz

Participants are required to complete Part 1 and 2 before they will be allowed to attempt the online quiz

Note: Attendance will be taken for all components and an e-certificate of completion will be issued after completion of the course.

*Programme may be subjected to change

Target Audience

All newly-hired CRCs involved in the conduct of clinical trials and clinical research studies (new hires and staff with less than 2 years of CRC experience);

CRCs with less than 6 months of clinical trial experience (i.e. interventional studies) would also benefit from attending the course.

Dates

Part 1 - eLearning: 27 February - 11 April 2023 (1.5 months)
Part 2 - Webinar lectures: 12 April 2023 (1 half day)
Part 3 - Online quiz: 13 April - 19 April 2023 (1 week)

Time

Part 2 - Webinar lectures: 9.00am to 1.00pm

The session will be opened 10 minutes prior in order to give all participants sufficient time to setup their account and contact us for any technical difficulties.

Note: Participants are advised not to schedule appointments/ meetings within the duration of the webinar.

Course Fees

S$646.92 (SingHealth staff, including GST)

S$776.52 (Non-SingHealth staff, including GST)

NOTE: Course fees* are not chargeable for Research Coordinators/ Clinical Research Coordinators (i.e. staff mapped to the CRC CDP) as it will be offset from your institution’s CT Vouchers programme. Please contact CTCC (ctcc@singhealth.com.sg) to check if you are eligible for this scheme.

* Full course fees will be charged to your department if you do not attend the course.

Class Size

50 - 70 pax

Venue

Online (via Webconference platform)

Organiser

SingHealth Academy & Clinical Trial Coordinating Centre

Registration Details

NOTE: Please inform and attain approval from your supervisor and respective institution HRs before sending in your registration.

To register, please email the following information to ask@singhealthacademy.edu.sg -

Full name:

Contact number:

Designation:

Department

Institution:

Email address:

SingHealth eLearning Portal User ID:

Mode of payment: Cheque/ Sponsored by Department/ CT Voucher

Supervisor's name:

Supervisor's designation:

Supervisor's email address:

Number of years of CRC experience:

Nature of research involved (apportion percentage if you are involved in >1 type of research):

S/N	Involvement	Weightage (%)
1	Clinical trials (interventional studies involving drug/biologics, medical device or procedures)
2	Clinical Research (non-interventional studies)
3	Medical Records Review (non-interventional and non-invasive)
4	Questionnaire/Survey/Interview (non-interventional and non-invasive)
5	Others (Please list):
Total		100

Example:

S/N	Involvement	Weightage (%)
1	Clinical trials (interventional studies involving drug/biologics, medical device or procedures)	20
2	Clinical Research (non-interventional studies)	30
3	Medical Records Review (non-interventional and non-invasive)	50
4	Questionnaire/Survey/Interview (non-interventional and non-invasive)
5	Others (Please list):
Total		100

Please register by 20 February 2023.

Registration is on a first-come, first-served basis. Successful registrants will be notified via email with information on payment details and instructions for completing the course.

In line with the Singapore Personal Data Protection Act (PDPA), please note that we have updated our SingHealth Data Protection Policy, a copy of which is available at http://www.singhealth.com.sg/pdpa. Hard copies are also available on request.

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