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


PCR Course features:

  • Contents updated with the latest regulatory controls, guidelines and SOPs
  • Online Learning format for greater flexibility and accessibility
  • Interactive lectures and quizzes to enhance learning and understanding
  • Case studies for selected topics to deepen learning, understanding and knowledge application

 
 

Courses Offered:

1. (PCR 001) Subject Recruitment and Informed Consent* 
    * The previous PCR200 has been replaced with PCR 001 (new course content)
 

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

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

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

 

 

 

1. (PCR 001) Subject Recruitment and Informed Consent 

Participants will gain knowledge and application principles for research subject recruitment and informed consent based on ethical and regulatory requirements throughout the phase of planning, designing, conducting and maintaining proper documentation. Best practices, tips and common errors will also be covered in this course which includes interactive case scenarios, and quizzes and informative reference materials.

This online module encompasses the following topics:                                                                             

Core Modules: 

  • Subject Recruitment
  • Informed Consent Requirements For Research
  • Informed Consent Process and Conduct

Supplementary Modules & Readings:

  • Waiver of Consent
  • Remote Consent
  • Additional reading materials on Subject Recruitment & Informed Consent

Learning Objectives:
      
Core Modules: 

  1. Understand the considerations for subject recruitment during the planning, designing, conducting and maintaining proper documentation.
  2. Understand the requirements and process for informed consent based on local regulations and guidelines.
  3. To apply relevant concepts and considerations when designing the informed consent process, obtaining informed consent and maintaining proper consent documentation for the different subject populations and study type.
  4. To identify and gain awareness of common errors in the subject recruitment and informed consent process.

Supplementary Modules & Readings:

  1. Understand the definition of remote consent, its appropriate application in research, the processes involved and documentation requirements.
  2. Understand the criteria for waiver of consent for Human Biomedical Research (HBR) and non-HBR studies, be familiar with the requirements and information to be included when requesting for waiver of consent.
  3. To identify the informed consent requirements for other special subject populations (e.g. research involving pregnant women, neonates and prisoners).
  4. Understand other processes involved in subject recruitment e.g. pre-screening, determining subject’s eligibility, subject follow-up and retention strategies.

 

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

 

 

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2. (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.
Self-Registration 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. 
Self-Registration 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. 
Self-Registration 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.