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

Overview

A 2-day beginner's course that equips entry-level Clinical Research Coordinators (CRCs) with the necessary know-hows, competencies and skills to perform and support of 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 

Day 1
  • Drug Development Process
  • History of Ethics
  • SingHealth CIRB
  • Regulatory requirements for Clinical Trials
  • Responsibilities of a PI and Sponsor
  • Responsibilities of a CRC
  • What to take note of in a protocol
  • Human Biomedical Research Act (HBRA)
  • Protecting subject confidentiality
Day 2
  • Informed consent and rights of vulnerable subjects
  • Investigator's Site File and Essential documents
  • What a CRC should take note of in Safety reporting
  • Management of Investigational Products
  • Management of Biological samples
  • How to prepare for a monitoring visit
  • How to prepare for an audit and inspection
  • Fraud & misconduct
  • How to manage patients
  • Quiz

Note: It is compulsory to participate in the quiz at the end of Day 2 to receive the certificate of attendance.
*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

  • 24 & 26 Jul 2019 (Wed & Fri)
  • 8 & 10 Jan 2020 (Wed & Fri)

Time

9.00am to 6.00pm  
Registration starts from 8.30am
Note: Participants are advised not to schedule appointments/ meetings within the duration of the workshop.

 

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.

Class Size

50 - 70 pax


Venue

Academia, 20 College Road, Singapore 169856
Level 1, L1-S1

Organiser

SingHealth Academy & Clinical Trial Coordinating Centre

Registration Details

NOTE: Please ensure that you submit the training request form to your respective HR departments for approval before sending in your registration.

To register, please email the following information to ask@singhealthacademy.edu.sg -    
Course Title: 
Full name: 
Contact number:
Designation:
Department 
Institution:
Email address:
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 10 July 2019.

Registration is on a first-come, first-served basis. Successful registrants will be notified via email with information on payment details.

   
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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