ICH-GCP: Good Clinical Practice for Study Nurses and Study Coordinators

This is an in-house seminar designed for companies / institutions working within the biopharmaceutical research industry, who would like to train their internal staff on becoming Study Nurses or Study Coordinators. To save travel costs for your employees the seminar can be held at the location of your choice.

PAREXEL Academy can arrange these in-house seminars following either our standard seminar programs or tailored to your particular needs. From experience, we consider that the optimum length for this seminar is 5 days.

Industry Trainings inhouse

ICH-GCP: Good Clinical Practice for Study Nurses and Study Coordinators

AIM

Over the past few years, regulations governing the conduct of clinical trials have become more and more stringent, placing greater demands on Investigators and study staff alike. To ensure the safety and wellbeing of subjects and patients at all times and the validity of data collected, clinical trials need to be carried out in accordance with national and international standards.

This intensive course teaches the basic principles of clinical research, and gives thorough insight into how clinical trials are conducted in hospitals and doctor’s practices. It also takes an in-depth look at recent developments in the field of clinical research and the latest legal and regulatory guidelines. Through the extensive use of authentic, blinded study documents and task-based learning, participants gain first-hand experience of the tasks required of a Study Nurse or Study Coordinator.

PARTICIPANTS

This intensive vocational course is aimed at medical staff wishing to qualify as Study Nurses or Study Coordinators. It is particularly suitable for:

  • Qualified nurses
  • Medical secretaries
YOUR BENEFITS

On completion of this course you will be able to work as Study Nurse or Study Coordinator on a clinical trial. The very practical nature of the course means that you will be familiar with all standard study documentation and procedures, and be able to perform all the tasks required of you in your daily work. You will obtain an understanding of the regulatory framework and the principles of Good Clinical Practice, both of which govern the conduct of clinical trials today. You will be aware of the roles and responsibilities of all parties involved in a trial, and the importance of accurate reporting and documentation to ensure patient safety and compliance with the study protocol. You will find out exactly what happens at qualification and initiation visits, and what to expect at regular monitoring visits once a study is up and running.

PROGRAM OVERVIEW

Note: The exact content of the course may vary in content and length in order to meet national and Ethics Committee requirements in different countries.

Introduction to Clinical Trials

  • Historical overview
  • The four phases of clinical trials
  • The drug development process

Study design

  • Guidelines and Laws in Clinical Research
  • The Nuremberg Code
  • The Declaration of Helsinki
  • Good Clinical Practice
  • International Conference of Harmonization

Roles and Responsibilities according to Good Clinical Practice

  • Investigator
  • Study Nurse
  • Monitor
  • Sponsor

Regulatory Framework

  • International and national legislation
  • Insurance cover
  • Data protection
  • Informed Consent

Submission and Application Process

  • Applications to the Ethics Commission
  • Applications to regional Responsible Authorities

Essential Documents

  • Study protocol
  • Patient information
  • Informed Consent process
  • Investigator Brochure

Patient Documentation in Case Report Forms (CRF)

  • CRF design
  • Paper vs. electronic CRF
  • Guidance for completion
  • Queries

Source Data

  • What constitutes source data?
  • Lab reports, ECG, etc.
  • Study-specific source data
  • CRF as source
  • Computerized medical records
  • Monitoring and source data

Practical Exercise

  • CRF completion from medical records

Investigator Brochure
Each participant will receive a sample Investigator Brochure

  • Contents
  • Central File / Trial Master File
  • File maintenance

Safety Reporting

  • Adverse Events (AE)
  • Adverse Drug Reactions (ADR) and causal relationships
  • Unexpected ADR
  • Severe Adverse Events (SAE)

Documentation and reporting procedures

  • Investigational Medicinal Products
  • Study and control treatment
  • Medical devices
  • Good Manufacturing Practice (GMP)
  • Labeling
  • Expiry, product stability, temperature
  • Randomization
  • Drug accountability, sample documentation
  • Unblinding

Laboratory Logistics

  • Local laboratory vs. central laboratory
  • Round-Robin
  • Test Certification, normal readings

Study Set-up

  • Site selection and Investigator recruitment
  • Pre-Study Visit
  • Responsibilities of the Investigator and study staff
  • Study Initiation Visit

Conduct of Study and Monitoring

  • Monitoring Visit
  • Responsibilities of the Investigator and study staff
  • Monitoring of CRF

Practical Exercise

  • Through the eyes of a Monitor

Quality Control, Audit and Inspection

  • Quality assurance
  • Quality control
  • Audits and audit reports

Study Coordination

  • Scheduling appointments with patients
  • Scheduling appointments with the Monitor
  • Observation of protocol guidelines
  • Patient compliance, patient guidance
  • Study logistics: blood samples | special examinations
  • Storage of study material
  • Payments

Data Management and the Query Process

  • Data cleaning
  • Scheduling
  • Purpose, participants, implementation
  • Investigator archiving
CONTACT US

To learn more about our in-house seminars and customized training options, or request a free proposal, contact us with information on the number of people to be trained, your preferred training location and your specific requirements.