In-Person Class Courses

The Clinical Research Coordinator (CRS)

Duration:

2 months, 80 hours

Frequency:

Weekend

Location:

Dubai and Abu Dhabi

Follow-up:

one-to-one coaching sessions available for following 2 months

Register Interest

Content:

  • Drug Development
    – Background of medicines development
    – Research and discovery stage & product development
    – Clinical development
  • GCP and historical milestones
    – Nuremberg Code
    – Declaration of Helsinki
    – ICH GCP E6 (R2)
    -FDA Regulation
  • Regulatory Authorisation
    – Clinical Trial Authorisation and approval
    – Ethic Committee
  • Study Design
    – Visit Schedule
    – Randomization
    – Informed Consent Form
  • CRO and the Monitor
    – Site management by CRO
    – The sponsor
    – Contractual Agreements
  • Site Staff
    – Delegation Log
    – Study team and back-up
    – CV and training records
  • Monitoring Visit
    – Communication with CRA
    – Visit activities
    – Issues management
    – Source Documents
    – Medical Records
    – ALCOA principles
  • Safety and Adverse Events
    – AE and SAE
    – identification and reporting of safety events
    – medical history
    – concomitant medication
  • Investigational Medicinal Product Management
    – Drug dispensing to patients
    – Role of pharmacy staff
    – Temperature excursion management
  • Data Entry
    – Clinical research form (CRFs)
    – Data query process

The Clinical Research Associate (CRA)

Duration:

2 months, 80 hours

Frequency:

Weekend

Location:

Dubai and Abu Dhabi

Follow-up:

one-to-one coaching sessions available for following 2 months

Register Interest

Content:

  • Drug Development
    – Background of medicines development
    – Research and discovery stage & product development
    – Clinical development
  • GCP and international standards
    -ICH GCP E6 (R2)
    -FDA Regulation
  • Regulatory Framework
    -Clinical Trial Authorisation and approval
    -Regulatory Inspections
  • Clinical Trial Protocol and ICF
    – Elements of a Study Protocol
    – Protocol Amendment
    – Informed Consent Form
  • CRA responsibilities
  • Study Start-up
    – Site selection, feasibility
    – Site Qualification Visit
    – Site Initiation Visit
    – Setting of Investigator Site File
  • Monitoring and Closing Clinical Trial Sits
    – Planning, conducting, documenting, reporting Visit
    – Issues management and escalation
  • Safety and Adverse Events
    -AE and SAE
    – identification and reporting of safety events
  • Investigational Medicinal Product Management
    – Drug Accountability
    – Role of pharmacy staff
    – Temperature excursion management
    – Managing expiry dates
    – Return of IMP
  • Data Management
    – Clinical research form (CRFs)
    – Source data verification
    – Data query process

The Principal Investigator (PI)

Duration:

2 weeks, 20 hours

Frequency:

Weekend

Location:

Dubai and Abu Dhabi

Follow-up:

one-to-one coaching sessions available for following 2 months

Register Interest

Content:

  • Responsibilities of a PI
  • The importance of leadership and supervision on a study team
  • The importance of direct oversight on study subjects and trial conduct
  • Tools available for the PI to conduct efficient and successful trials
  • Site Selection
  • The informed consent process
  • The communication with the CRA
  • The communication with the Medical Monitor
  • The Clinical Trial Protocol
  • The Investigator Brochure
  • The reporting of AE/SAE
  • The Investigational Product dispensing
  • Subject recruitment and retention
  • Scientific misconduct in clinical trials
  • Site visit, site audits
  • Site regulatory Inspections

ONLINE MODULES

The following modules have been developed by ClinQA Solutions to address the educational needs of different end-users, having different level of knowledge on Clinical Research (from beginners, to experienced).

The modules can be delivered on a ‘stand-alone’ basis or as part of tailored courses comprising of a selection of modules as per client requirements.

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WORKSHOPS

Our workshops are developed to address our clients’ needs and are delivered in-person or remotely, depending on the number of instructors required. The workshop have a duration of 1, 2 or 3 days.

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Ad-hoc classes can be scheduled with organisations in need of a group training to be delivered.

If you would like to discuss ad-hoc classes,
BOOK A CALL with our team.

BOOK A CALL