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Accredited Clinical Research Monitor Programme    Back

International Academy of Clinical Research Course Type: Short courses (CPD) Start Date: To be announced
Location: , United Kingdom Duration: Full time - 8 Days Fees/total cost: EUR 3,729.85 (GBP 2,714.00)

Description

PART 1 - Basic Technical Skills Workshop (Standard Stream Only)

This is a 3 day workshop for CRAs with less than six months experience which covers the following topics:

Context & Environment

  • Roles and responsibilities of a CRA
  • Investigator responsibilities
  • Clinical trial reports
  • Basics of clinical trial design
  • Clinical research protocols
  • Case report forms
  • Role of clinical laboratories
  • Participating in audits and regulatory inspections

Pre-Trial Preparation

  • Conducting pre-study evaluation visits
  • Regulatory environment and submissions
  • Managing essential documents
  • Conducting initiation visits
  • Pre selecting clinical investigators
  • Monitoring During Patient Recruitment
  • Review of on-site monitoring visit activities
  • Patient eligibility
  • Reviewing informed consent
  • Adverse event reporting
  • Source data verification and case report form review
  • Managing use of electronic records (including eCRFs and medical notes)
  • Managing essential documents
  • Detecting and handling fraud, misconduct and errors
  • Monitoring visit reports
  • IMP managementPost-Patient

Recruitment Activities

  • Managing essential documents
  • IMP accountability after patient recruitment
  • Conducting final (close-out) visits
  • Investigators post–study responsibilities

PART 2 - Professional Skills Workshop (Standard & Accelerated Streams)

This 2 day professional skills workshop is designed for all CRAs wishing to achieve the Accredited Clinical Research Monitor standard. It builds on the knowledge gained in the Basic Technical Skills workshop and skills acquired during planned workplace based learning and development activities (refer to IAoCR Competency Checklist for further information).

The Professional Skills workshop covers the following topics:

  • Experience sharing and reflections
  • Common issues at site and how to manage them
  • Taking a proactive, risk-based approach
  • Working with complex studies and challenging sites
  • Applying problem solving and decision making techniques to issues at site
  • Prioritising a busy workload to maximise effectiveness at site
  • Working with sites to encourage ethical patient recruitment

PART 3 - Professional Behaviours Workshop (Standard & Accelerated Streams)

This 3 day professional behaviours workshop is designed for all CRAs wishing to achieve the Accredited Clinical Research Monitor standard. It builds on the knowledge gained in the previous two workshops and skills acquired during planned workplace based learning and development activities (refer to IAoCR Competency Checklist for further information). For CRAs to perform their role effectively and professionally it is essential that they can work collaboratively with others and represent the Sponsor as a credible and professional organisation. The competencies covered in this workshop help CRAs to develop the essential professional behaviours required of them and consider how to apply them whilst at site and in the workplace.

The Professional Behaviours workshop covers the following topics:

Experience sharing and reflections

  • Assertive communication
  • Non-verbal communication
  • Effective and professional emails and letters
  • Informative visit reports
  • Telephone etiquette
  • Meeting and teleconference etiquette
  • Active listening and questioning techniques

Communicating effectively and professionally

Using professional communication techniques during pre-study evaluation visits, initiation visits and monitoring visits for study compliance

Interviewing potential investigators

Dealing assertively with objections and challenging situations

Managing difficult questions with confidence

Understanding the use of power, influence and negotiation

Learning Outcomes

Being finalised with accrediting body

Full time

Duration:
8 Days
Teaching method:
Blended
Language:
English
Venue:
, United Kingdom
Standard applicant fee:
EUR 3,729.85 (GBP 2,714.00)

Course contact information

Dr Martin Robinson
Principal Director
Learning & Education
mrobinson@iaocr.com
This course meets 9 out of 9 IMI Education & Training shared quality standards ( Show Details)
  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered
Last update: 21/09/2015