Course curriculum

  • 1

    Chapter 1: What is an Audit?

    • Who performs an audit?

    • Why are audits done?
  • 2

    Chapter 2: Policies, SOPs, Forms

    • Introduction to: Critical SOPs

    • Consenting

    • Archiving

    • Investigator File

    • Serious Adverse Events (SAE)
  • 3

    Chapter 3:Regulatory environments

    • Canada

    • USA
  • 4

    Chapter 4: Tools for collaboration

    • Microsoft teams

    • Microsoft FORMS

    • Microsoft Power apps
  • 5

    Chapter 6: The Start-up

    • Regulatory submission

    • Source documents

    • Creating team and monitoring plan
  • 6

    Chapter 8: Preparing for an audit - dos and dont's

    • What they will want to see

    • Documentation ALCOA Standards
  • 7

    Chapter 9: Critical SOPs

    • .001 Document Control and Archiving

    • .002 Informed Consent and Assent

    • .003 Adverse and Serious Adverse Events, Safety Letters

    • .004 Principal Investigator (PI) Oversight and Delegation of Authority

    • .005 Drug Transportation, Storage, Distribution, and Destruction

    • .006 Source Documents and Case Report Forms

    • .007 GCP, TCPS 2 and Division 5 Training

    • .008 Pre-screening

    • .009 Study Participant Safety and Safety Plan for Aggressive Patients

    • .010 Natural Disaster Plan

    • .011 Equipment Calibration and Maintenance

    • .012 Collection, Handling, and Shipping Biological Samples