Medical Writing Certification — Professional

Lesson material opens once you are enrolled. The full syllabus and every learning outcome are shown here so you can judge the coverage before you pay.

1. Module 1

   1

   1 lesson

   1. Locked.The landscape, the two tracks, and the document lifecycleLocked

      On completion you will be able to

      • By the end, the learner can:
      • Place any named clinical document in the development lifecycle and state who owns it, who reviews it, and what consumes it downstream. [R]
      • Distinguish regulatory writing from medical communications as career tracks with different clients, deliverables, timelines and quality regimes. [R]
      • State accurately what AMWA/MWCC, EMWA, ISMPP and BELS each offer, and articulate the certificate/certification distinction in the terms those bodies themselves use. [R]
      • Analyse the confidentiality and conflict-of-interest obligations that attach to sponsor-side, CRO, agency and freelance engagements, and identify where they differ. [An]

2. Module 2

   2

   1 lesson

   1. Locked.Scoping the assignment: source packs, contributor maps, document plansLocked

      On completion you will be able to

      • Specify the complete source pack a named document requires before drafting can responsibly begin. [A]
      • Construct a contributor and review map identifying who provides content, who reviews, who approves, and who has no standing to change the document. [C]
      • Evaluate a proposed timeline against the review cycles it actually implies, and state where it will fail. [E]

3. Module 3

   3

   1 lesson

   1. Locked.The clinical study protocol as a documentLocked

      On completion you will be able to

      • Draft a protocol body from a supplied synopsis and statistical analysis plan with internally consistent objectives, endpoints, populations and analyses. [C]
      • Construct an objectives-and-endpoints table in which every objective has an endpoint, every endpoint has an analysis, and the primary / secondary / exploratory hierarchy is explicit. [C]
      • Analyse a supplied protocol for the six classes of internal inconsistency and produce a defect list. [An]
      • Evaluate eligibility criteria for operational workability at the site, and justify a recommended rewrite. [E]

4. Module 4

   4

   1 lesson

   1. Locked.Protocol amendments and the investigator’s brochureLocked

      On completion you will be able to

      • Draft a protocol amendment with change, rationale, affected sections, impact on enrolled subjects, and a summary-of-changes document. [C]
      • Distinguish a substantial from a non-substantial amendment and write to the correct standard. [A]
      • Draft and update an investigator's brochure, integrating nonclinical and clinical data into a benefit–risk statement. [C]
      • Evaluate a reference safety information section for whether expectedness assessment can actually be performed against it. [E]

5. Module 5

   5

   1 lesson

   1. Locked.ICH E3: the structure of the clinical study reportLocked

      On completion you will be able to

      • Reproduce the ICH E3 top-level section structure and place any supplied content fragment in its correct section and sub-section. [R] [A]
      • Plan a CSR from a protocol, a statistical analysis plan and a TLF package, producing a section-by-section source map. [C]
      • Analyse the sub-structure of E3 Sections 9, 11 and 12 and state what each sub-section is for. [An]
      • Evaluate whether an abbreviated report is appropriate for a supplied study and justify the conclusion. [E]

6. Module 6

   6

   1 lesson

   1. Locked.Writing the CSR: efficacy, safety, narratives and the review cycleLocked

      On completion you will be able to

      • Write efficacy and safety text that states what the tables show, without over-claiming, under-claiming, or introducing numbers absent from source. [C]
      • Write patient narratives for deaths, other serious adverse events and discontinuations for adverse events, to a consistent template and from source. [C]
      • Analyse a supplied CSR safety section against its supplied tables and produce a discrepancy log. [An]
      • Evaluate a set of review comments and determine which to implement, which to reconcile, and which to escalate. [E]

7. Module 7

   7

   1 lesson

   1. Locked.Submission architecture: the CTD, Module 2 and traceabilityLocked

      On completion you will be able to

      • Place any supplied clinical document in the correct Common Technical Document module. [A]
      • Draft Module 2 clinical summary and overview text from Module 5 source at the correct level of abstraction for each. [C]
      • Maintain and demonstrate traceability from a Module 2 statement back to the CSR and from the CSR back to the tables, listings and figures. [C]
      • Evaluate a supplied Module 2 summary for the failure mode of being a condensed CSR rather than a differently-argued document. [E]

8. Module 8

   8

   1 lesson

   1. Locked.Informed consent, readability and plain-language rewritingLocked

      On completion you will be able to

      • Draft an informed consent form and participant information sheet from a supplied protocol, covering the required elements. [C]
      • Apply a defined readability method and state what it does not measure. [A]
      • Rewrite clinical and regulatory language into plain language without losing accuracy, and identify rewrites that have lost accuracy. [An]
      • Evaluate risk communication in a supplied document against numeracy principles. [E]

9. Module 9

   10

   1 lesson

   1. Locked.Publication planning and GPP 2022Locked

      On completion you will be able to

      • Build a publication plan from a supplied clinical development plan: what is published, in what sequence, in what venue, with what author group, on what timeline. [C]
      • Apply GPP 2022 to a live publication-planning decision and state which provision governs. [A]
      • Evaluate a publication plan for selective-reporting risk. [E]
      • Analyse congress and journal rules for the interaction of embargo, encore presentation, prior publication and preprints. [An]

10. Module 10

    11

    1 lesson

    1. Locked.Authorship, acknowledgment, ghostwriting, disclosure and AILocked

       On completion you will be able to

       • Apply the four ICMJE authorship criteria to a supplied industry-sponsored author group and produce a defensible outcome, including declining authorship. [A] [E]
       • Write acknowledgment and funding statements that disclose professional medical-writing assistance correctly. [C]
       • Identify a ghostwriting arrangement from supplied contractual and correspondence evidence, and state precisely what makes it one. [An]
       • Apply a target venue's current AI-disclosure requirement to a concrete drafting scenario. [A]

11. Module 11

    12

    1 lesson

    1. Locked.Safety, benefit–risk and value documentsLocked

       On completion you will be able to

       • Draft a development safety update report from supplied safety data and reference safety information. [C]
       • Draft periodic benefit–risk evaluation report sections integrating exposure data, signal evaluation and benefit–risk conclusions. [C]
       • Distinguish a safety conclusion from a benefit–risk conclusion and explain why the second cannot be written from safety data alone. [An]
       • Evaluate a supplied benefit–risk narrative for concealed uncertainty. [E]
       • Analyse how the evidence standard in a value dossier differs from that in a regulatory submission. [An]

12. Module 12

    13

    1 lesson

    1. Locked.Style authorities, QC against source, and document controlLocked

       On completion you will be able to

       • Perform and document a fact-check of a supplied document against its source: every number, every derived statement, every cross-reference, every citation. [A] [C]
       • Design a QC plan proportionate to a document's risk, stating what is 100 %-checked and what is sampled, and why. [C]
       • Resolve conflicts between a style authority, a sponsor style guide, a journal's instructions and a regulatory template, in the correct order of precedence. [E]
       • Analyse a supplied document for the failure modes that survive proofreading. [An]
       • Maintain version control, change history and approval records to a standard that would survive inspection. [A]