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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
  • Drug Development Process
  • History of Research Ethics
  • PI and Sponsor's Responsibilities in Clinical Research Studies
  • Responsibilities of a CRC during the pre-study phase
  • 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
  • Human Biological Research Act (HBRA) Essentials
  • User Guide for SCM CTR Research Note
Part 2: Webinar lectures
  • Regulatory Requirements for Clinical Trials
  • SingHealth CIRB
  • Responsibilities of a CRC during study phase and close-out
  • Informed Consent Process and Documentation
  • Management of Investigational Products
  • How to prepare for a monitoring visit
  • What a CRC should take note of in safety reporting
  • How to prepare for an audit and inspection
  • How to manage patients
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: 7 Sep - 7 Oct 2020 (1 month)
  • Part 2 - Webinar lectures: 8 & 9 Oct 2020 (Thur & Fri)
  • Part 3 - Online quiz: 12 - 18 Oct 2020 (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$599 (SingHealth staff, excluding GST)
S$719 (Non-SingHealth staff, excluding 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/NInvolvementWeightage (%)
1Clinical trials (interventional studies involving drug/biologics, medical device or procedures) 
2Clinical Research (non-interventional studies) 
3Medical Records Review (non-interventional and non-invasive) 
4Questionnaire/Survey/Interview (non-interventional and non-invasive) 
5Others (Please list):
Total100

 

Example:

S/NInvolvementWeightage (%)
1Clinical trials (interventional studies involving drug/biologics, medical device or procedures)20
2Clinical Research (non-interventional studies)30
3Medical Records Review (non-interventional and non-invasive)50
4Questionnaire/Survey/Interview (non-interventional and non-invasive)
5Others (Please list):
Total100

Please register by 30 Sep 2020.

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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