Pharmacovigilance & Drug Safety Certification — Foundation

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1. Module 1

   F-M1

   1 lesson · 7 h

   1. Locked.The vocabulary of safety7 h · Locked

      On completion you will be able to

      • On completion the learner can:
      • Define adverse event, adverse drug reaction, suspected adverse reaction, serious adverse event, serious adverse reaction and SUSAR, and cite the document each definition comes from.
      • Distinguish "serious" from "severe" and explain why the distinction determines a reporting obligation.
      • Apply the five seriousness criteria and the important-medical-event clause to described occurrences.
      • Explain why E2A and E2D define overlapping terms differently.
      • Identify deprecated and imprecise usage — "side effect", "AE" used where "ADR" is meant, "serious" used to mean "bad".
      • Recognise that an adverse event of special interest is a sponsor construct and not a regulatory seriousness category.

2. Module 2

   F-M2

   1 lesson · 5 h

   1. Locked.From a report to a case5 h · Locked

      On completion you will be able to

      • The learner can:
      • Determine whether an incoming report meets the minimum criteria to constitute a valid case, and state which list they applied.
      • Identify day zero for a described intake.
      • Classify a report by source — spontaneous, solicited, literature, regulatory authority.
      • Specify what follow-up must be sought and explain what a follow-up report restarts.
      • Explain why duplicate detection is a safety activity rather than an administrative one.

3. Module 3

   F-M3

   1 lesson · 6 h

   1. Locked.The three axes: serious, unexpected, related6 h · Locked

      On completion you will be able to

      • The learner can:
      • Assess seriousness, expectedness and causality as three independent judgements and explain why collapsing any two produces a reporting error.
      • Select the correct reference document for an expectedness assessment.
      • Apply E2A's specificity/severity rule to determine that a more specific or more severe manifestation of a listed reaction is unexpected.
      • State who may make a causality determination and explain why a sponsor's disagreement does not remove reportability.
      • Combine the three axes to reach a reporting decision.

4. Module 4

   F-M4

   1 lesson · 5 h

   1. Locked.Coding and grading5 h · Locked

      On completion you will be able to

      • The learner can:
      • Name the five MedDRA levels in order and state which provides maximum specificity.
      • Explain multi-axiality and state what the primary SOC prevents.
      • Distinguish MedDRA's purpose from CTCAE's and select the right one for a stated purpose.
      • Read a CTCAE grade correctly and explain why a grade is not a seriousness determination.
      • Identify a version-alignment problem between a protocol, a grading scale and a coding dictionary.

5. Module 5

   F-M5

   1 lesson · 5 h

   1. Locked.Clocks and destinations5 h · Locked

      On completion you will be able to

      • The learner can:
      • Determine whether a case qualifies for expedited reporting.
      • State the applicable timeline and name the jurisdiction it comes from.
      • List every party entitled to receive the report.
      • Distinguish the regulatory clock from the protocol clock and from the IRB/IEC requirement.

6. Module 6

   F-M6

   1 lesson · 3 h

   1. Locked.The safety landscape3 h · Locked

      On completion you will be able to

      • The learner can:
      • Contrast trial pharmacovigilance with post-marketing pharmacovigilance on reference document, population, denominator and reporting framework.
      • Name the principal spontaneous reporting systems and state what each covers.
      • Explain why spontaneous data cannot support incidence estimation.
      • Describe, at awareness level, what a signal is and what a risk management plan is for.