SINGHEALTH MARKETPLACE / CLINICAL RESEARCH
Clinical Research Coordinator Essentials
Explore 12 focused e-learning modules covering essential topics in clinical research coordination, from drug development and research ethics to study conduct, documentation and investigational product management.
12 modules | 30 minutes per module | S$100 per module | 3 months access from purchase
Explore all 12 modules
Select a module to view its synopsis, learning outcomes and course outline. Each module is purchased separately through Intellicart.
Module 1: Drug Development · 30 min · S$100
Course synopsis
Drug development is an essential part of clinical research. This module touches on the importance of clinical trials and the arduous amount of effort and time required in developing new drugs.
Learning outcomes
This module will provide an insight to the timeline of drug development and the various phases of clinical trials.
Course outline
- Timeline of drug development
- Drug development process
- The different phases of drug development
- The importance of drug development in clinical trials
Duration: 30 minutes | Access: 3 months from purchase
Module 2: History of Research Ethics · 30 min · S$100
Course synopsis
Before we dive into the key component of clinical research, it is imperative to apprehend the background of research ethics on human participants. Unethical research may put human participants at risk and even jeopardise validity of the research findings.
Learning outcomes
This module will provide a brief history of research ethics and overview of the international ethical guidelines of clinical research involving human participants. This module will provide an insight to the timeline of drug development and the various phases of clinical trials.
Course outline
- Defining what is ‘Ethics’
- A brief introduction to the ‘History of Research Ethics’
- What is Belmont Report?
- How Good Clinical Practice came about
Duration: 30 minutes | Access: 3 months from purchase
Module 3: Protocol · 30 min · S$100
Course synopsis
The protocol is a vital study document in a clinical study. It provides key details of what is required of the study and it is crucial for a CRC to have comprehensive knowledge on the design of the study through the protocol.
Learning outcomes
This module will provide details to the elements that make up a well-designed protocol.
Course outline
- The definition of a protocol
- The responsibilities of a CRC in managing a protocol
- The common elements in a protocol
Duration: 30 minutes | Access: 3 months from purchase
Module 4: PI and Sponsor Responsibilities in Clinical Research Studies · 30 min · S$100
Course synopsis
CRCs will be assisting the Principal Investigators (PI) and Sponsors in coordinating the study procedures for the clinical study and also help to maintain the essential documents of the study. Therefore it is important for the CRC to know about the different responsibilities of the PI and Sponsor.
Learning outcomes
This module will provide details on the roles and responsibilities of the PI as outlined in the ICH GCP guidelines especially in the case of investigator-initiated trials, as well as the role of the Sponsor in industry sponsored trials.
Course outline
- CRC’s role in supporting the Principal Investigator (PI)
- Role & Responsibilities of a PI
- The role of a Sponsor as outlined in ICH GCP
Duration: 30 minutes | Access: 3 months from purchase
Module 5: CRC Responsibilities During Pre-study Phase · 30 min · S$100
Course synopsis
Being aware and understanding what your role as the CRC of a clinical research study is the first step in ensuring a smooth conduct of the study.
Learning outcomes
This module will cover the responsibilities required of the CRC during the pre-study phase of a clinical research study.
Course outline
- Importance of CRC in clinical research
- Training requirements
- CRC’s role in maintaining the ISF and essential documents
- CRC’s role in organising Investigator meetings and site initiation visits
Duration: 30 minutes | Access: 3 months from purchase
Module 6: CRC Responsibilities During Study and Post-study · 30 min · S$100
Course synopsis
Being aware and understanding what your role as the CRC of a clinical research study is the first step in ensuring a smooth conduct of the study.
Learning outcomes
This module will cover the responsibilities required of the CRC during the study as well as post study.
Course outline
- Subject Screening and Recruitment
- Study Scheduling
- Lab Reports
- IP Management
- Source Documents and Data Entry
- Safety Reporting
- Study Closeout
Duration: 30 minutes | Access: 3 months from purchase
Module 7: Essential Records · 30 min · S$100
Course synopsis
Essential records are important as they assist the investigator, sponsor and study monitor in the successful management of the study. The CRC plays a key role in helping to file and properly maintain the essential records at the study site.
Learning outcomes
This module will provide an insight to the management of the essential documents at all stages of the clinical study according to ICH GCP guidelines.
Course outline
- What are Essential Records?
- Why is it important?
- Who is responsible for maintaining the Essential Records?
- How are Essential Records maintained?
- Management of Essential Records Before, During and After a study
- Where should the Essential Records be kept?
Duration: 30 minutes | Access: 3 months from purchase
Module 8: Maintenance of Investigator Site File · 30 min · S$100
Course synopsis
The Investigator Site File (ISF) stores all the essential documents of the clinical study. The CRC in charge will need to help the Principal Investigator to properly maintain these documents in the ISF.
Learning outcomes
This module will provide details on the importance of the documents filed in the ISF according to the ICH GCP guidelines.
Course outline
- Importance of maintaining an Investigator Site File (ISF)
- How to maintain the documents in an ISF
- Common Issues Faced
Duration: 30 minutes | Access: 3 months from purchase
Module 9: Investigational Product Accountability and Storage · 30 min · S$100
Course synopsis
Management of the investigational product is an important role of the CRC as it ensures the protection, safety and well-being of the human participants enrolled into the clinical trial.
Learning outcomes
This module will provide details on the importance of maintaining and handling investigational product in a clinical trial according to the ICH-GCP guidelines.
Course outline
- What is an Investigational Product (IP)
- Sponsor’s Responsibility
- Investigator’s Responsibility
- IP Management
- Documentation
- Other IP Related Matters
- Scenarios
Duration: 30 minutes | Access: 3 months from purchase
Module 10: Management of Biological Samples · 30 min · S$100
Course synopsis
Most clinical research study procedures involve the collection of biological samples from human participants. It is essential for CRCs to understand what is their role when handling and managing such biological samples.
Learning outcomes
The standards that are outlined in this module follows the stringent requirements of ICH-GCP for the management and handling of biological samples which are collected while conducting human biomedical research studies.
Course outline
- GCP Considerations
- Specimen Handling
- Standard Operating Procedures or Lab Manual
- Local / Central Labs
- Shipping
- Reporting
- Laboratory Certificates
- Issues
Duration: 30 minutes | Access: 3 months from purchase
Module 11: Preparation for Monitoring Visit · 30 min · S$100
Course synopsis
It is important to ensure that all clinical trials are conducted in accordance with the protocol, ICH GCP guidelines and applicable regulatory laws. As such, monitoring visits may be conducted periodically on the study to ensure that no deviations have occurred. The role of a CRC is to assist the study team to prepare for each monitoring visit.
Learning outcomes
This module will provide details on how to assist the Principal Investigator in preparing for monitoring visits.
Course outline
- The objectives of monitoring
- The differences between monitoring, audit and inspection
- The differences between Quality Assurance and Quality Control
- How to prepare for a monitoring visit (MV)
- Some tips on Good Documentation Practices
- How to maintain electronic database
- The key qualities in maintaining data and study records
- The things to follow-up after completion of MV
Duration: 30 minutes | Access: 3 months from purchase
Module 12: Fraud and Misconduct · 30 min · S$100
Course synopsis
Despite the clear guidelines stated in ICH-GCP for the proper conduct of clinical research, there has been an increase in cases of fraud and misconduct committed by members of the study team in recent years. It is crucial for CRCs to be aware of the ICH GCP guidelines to ensure that the rights, safety and well-being of research subjected are well protected.
Learning outcomes
This module will provide insight on the types of fraud and misconduct that may be committed and explain the importance of preventing these from occurring.
Course outline
- Definition of Fraud
- Definition of Misconduct
- Types of Fraud and Misconduct
- Who commits Fraud and reasons for doing it
- Consequences of Fraud
Duration: 30 minutes | Access: 3 months from purchase
Important information
All purchases are final and non-refundable. Learners must complete each module within the 3-month access period. Materials are for individual learning only and must not be reproduced, shared or distributed without permission. Accounts may be deactivated after 6 months of inactivity.
Course enquiries: contactctcc@singhealth.com.sg
Technical assistance, access issues or reactivation: elearning.helpdesk@singhealthacademy.edu.sg
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