Translating Research into Highest Quality Patient Care

Proper Conduct of Research Courses (PCR)




Course Overview
The Proper Conduct of Research (PCR) SOP are a set of guidelines developed by the NHG Group Research to provide detailed procedures on conducting research in accordance with applicable guidelines and regulations.

The Proper Conduct of Research (PCR) courses seek to equip Clinical Research professionals with the knowledge and skills in the proper conduct of research.

The entire series of PCR Courses comprises 4 main modules, with multiple topics covered under each module. Participants are encouraged to sign up for all 4 modules to obtain a holistic appreciation of all the aspects of PCR. There are no pre-requisites to be fulfilled for taking each PCR Modules.


Who Should Attend:
Investigators, Researchers, Clinical Research Coordinators, Research Assistants


New PCR Course features:
 

  • Contents updated with the latest regulatory controls, guidelines and SOPs
     
  • Blended Learning format (with online lectures) for greater flexibility and accessibility
     
  • Classroom workshops focuses on practical aspects and skills for research conduct
     
  • Case studies and Discussions for selected topics to deepen learning, understanding and knowledge application.


Introducing the new series of PCR Courses (monthly online lectures with Classroom workshops)

 
 

Courses Offered:

1. (PCR 100) Study Start Up: Case Report Form Design, Database Design, Using REDCap and Budgeting  

2. (PCR 200) Study Conduct I: Subject Recruitment and Informed Consent

3. (PCR 300) Study Conduct II: Documentation, Safety Reporting and Investigational Product (IP) 


4. (PCR 400): Monitoring, Audits and Inspections

 

 

 

1. (PCR 100) Study Start Up: Case Report Form (CRF) Design, Database Design, Using REDCap and Budgeting  

Participants will learn about the general principles involved in budgeting, design and use of a case report form, database design and have an overview understanding of how REDCap is used in NHG to aid in data analysis and capture in research.

This online module encompasses the following topics relating to the conduct of research studies:

  • Design Case Report Forms (CRF) - This topic details the introduction, general principles and components of case report forms and its completion guidelines. 
  • Introduction to Database Design - This topic details the introduction to types of database management systems, concepts and principles of good database design. 
  • REDCap – All you need to know about using REDCap in NHG - This topic introduces REDCap as a web-based electronic data capture solution that is designed for collecting clinical research data in a secure and systematic manner. 
  • Budgeting for Clinical Trials and Competitive Grants - This topic details the factors affecting budget and the considerations when budgeting for competitive grants. 
  • Account Maintenance - This topic details on managing accounts and study closure budget.

 

Learning Objectives:
  1. To design case report forms for use in clinical research studies and clinical trials.
  2. To design databases to organise information collected in research studies.
  3. To have an overview of how REDCap is used in NHG.
  4. To ensure that all the budgets are accounted for in clinical trials.
  5. To ensure that all factors are considered when budgeting for competitive grants.
  6. To have an overview of how study accounts are maintained from creation to closure.
Note: With effect from 1 Apr 2022, the classroom workshop has been converted to online learning via eLEARN.

 

Click here to register.
How to Download your eCertification on eLEARN 
Important notice for NHG Staff: Click here to register for the course.
Resgistration Guide for NHG Staff 


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2. (PCR 200) Study Conduct I: Subject Recruitment and Informed Consent 

 
Participants will acquire some strategies for subject recruitment and the principles of obtaining consent from research subjects and to apply the necessary safeguards for taking consent in vulnerable populations. Proper documentation required for consent taking will also be covered.  
 
This online module encompasses the following topics relating to the conduct of research studies:
  • Subject Recruitment, Follow-up & Retention and Innovative Recruitment Strategies
  • Developing Your Informed Consent Form 
  • Informed Consent Process, Documentation and Additional Requirements 
  • Informed Consent: Research Involving Minors, Pregnant Women and Prisoners  
  • Informed Consent: Research Involving Cognitively Impaired Persons
  • Informed Consent: Waiver of Consent in Special Circumstances 
Learning Objectives:
  1. To employ appropriate strategies for subject recruitment, follow-up and retention in research studies.
  2. To maintain proper documentation related to subject recruitment and follow-up.
  3. To understand the innovative strategies for subject recruitment in comparison to traditional recruitment strategies.
  4. To understand the concepts on how to:
    • Conduct the informed consent process for potential research subject.
    • Perform and maintain proper documentation for the informed consent process.
    • Apply the additional requirements and safeguards for consent taking in special subject populations (i.e. cognitively impaired persons, minors).
“Note for NHG Staff: NHG Study Team Members (e.g. Clinical Research CoordiHBR ERC Classroom Workshop Exemption Criterianators, Research Assistants) are exempted from completing the HBR ERC Classroom Workshop as part of the New NHG HBR Minimum Training Requirement if they had completed NHG PCR 200 prior to 1 April 2022 or SCRI-NHG (PCR200). Click on the following for the HBR ERC Classroom Workshop Exemption Criteria.”
 
Note: There will be no classroom workshop with effect from 1 April 2022.

 

Click here to register. 
How to Download your eCertification on eLEARN 
Important notice for NHG Staff: Click here to register for the course. 
Resgistration Guide for NHG Staff 

 

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3. (PCR 300) Study Conduct II: Documentation, Safety Reporting and Investigational Product (IP) 

 
The online topics introduces the types of essential documents to be maintained in the investigator file, the principles of good documentation and common documentation pitfalls. Participants will also gain a better understanding about the safety reporting requirements for both investigator-initiated and sponsored trials, and an appreciation of the myriad regulations governing investigational product management in clinical trials. Participants will learn about handling investigational products in according with Good Clinical Practice principles.
 
This online course encompasses the following topics relating to the conduct of research studies:
  • Essential Documents and Proper Documentation – This topic details the essential documents to be maintained in the investigator file, some good documentation practices and common documentation pitfalls.
  • NHG DSRB Safety Reporting Requirements - This topic seeks to inform researchers on DSRB’s safety reporting requirements
  • Safety Reporting in Clinical Trials (Part I & II) – This topic seeks to inform researchers on the safety reporting requirements in clinical trials.
  • Investigational Product (IP) Management and Documentation – This topic seeks to inform researchers on the principles of good IP management and documentation in accordance with Good Clinical Practice. 
 
Learning Objectives:
  1. To maintain the essential documents and investigator file for a research study.
  2. To perform proper documentation in a research study.
  3. To understand and apply the safety reporting requirements for research studies, as required by HSA and DSRB.
  4. To apply the regulatory requirements to investigational product management at the clinical trial site.
  5. To ensure proper handling of IP at the study site.
  6. To maintain proper documentation related to handling of investigational products in clinical trials.
Note: With effect from 1 Apr 2022, the classroom workshop has been converted to online learning via eLEARN

 

Click here to register. 
How to Download your eCertification on eLEARN 
Important notice for NHG Staff: Click here to register for the course. 
Resgistration Guide for NHG Staff 


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4. (PCR 400) Monitoring, Audits and Inspections 

 
This course features the closely related topics of monitoring, audits and inspections. The online modules will allow participants to understand the purpose of site monitoring, responsibilities of monitors, and concepts surrounding risk-based monitoring; including the process of audits and inspections, conducted either by external parties and/or regulatory authorities. 
 
This online course encompasses the following topics relating to monitoring, audits and inspections:
  • An Introduction to Site Monitoring
  • How to Conduct Site Monitoring (Site Monitoring Visit Preparation, Conduct & Follow-Up)
  • Overview of Monitoring, Audits and Inspections 
  • Preparing for Audits and Inspections 
  • Risk-Based Monitoring: An Introduction 
 
Learning Objectives:
  1. To apply concepts of risk-based monitoring to clinical trials.
  2. To be familiar with the procedures to be followed before, during and after audits and inspections.
  3. To prepare research studies for audits and inspections. 
Note: There will be no classroom workshop with effect from 1 April 2022.

 

Click here to register. 
How to Download your eCertification on eLEARN 
Important notice for NHG Staff: Click here to register for the course. 
Resgistration Guide for NHG Staff 

 

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For any enquiries, please contact the Research Course Admin at research_courseadmin@nhg.com.sg


Note/Disclaimer: Participants are encouraged to select the courses based on their learning needs. All courses are available to the public. Please note that course details are subjected to changes without prior notice. Please check course registration page for more information.