Start here

Choose the document before you choose the template

Chapter 1 of 292 min read

A template can make a document look familiar before the team has decided what the document needs to do. Route the work through five questions first:

  1. What decision or understanding must the output support? Publication, study conduct, authority review, safety assessment, reimbursement, professional education, patient choice, or another use?
  2. Who is the primary reader? Specialist, general clinician, investigator, regulator, payer, author team, learner, patient, caregiver, or public audience?
  3. What is the evidence object? One study, a development program, a case, a body of literature, a model, post-market information, expert discussion, or a controlled claim set?
  4. What level of method must be visible? Narrative synthesis, reproducible evidence review, formal study reporting, regulated dossier integration, instructional design, or plain-language transformation?
  5. What is the destination? Journal, congress, authority, sponsor system, payer body, field team, website, participant, or internal decision forum?

The answers identify the family and subtype. A study-based manuscript and a narrative review may both be journal articles, but their evidence engines differ. A plain-language summary of a paper and a lay summary of clinical-trial results may share communication techniques while serving different source and process requirements. A clinical protocol manuscript describes a study to the scientific community; a regulated clinical protocol controls how the study will be conducted.

Routing table

Starting pointLikely familyDecisive distinction
Results from one planned studyOriginal research manuscript, abstract, poster, CSR, or public results summaryReader, regulatory status, detail, and destination
A defined question across many studiesNarrative review, systematic review, meta-analysis, HTA, CER, or evidence dossierSearch rigor, appraisal, jurisdiction, and decision use
Planned researchProtocol, protocol paper, grant, ethics application, consent materialConduct control versus scientific communication
One patient or clinical eventCase report or safety narrativePublication lesson versus regulated case documentation
Product or program evidenceIB, CTD overview/summary, scientific platform, value dossier, medical-information responseLifecycle, authority, and approved-use context
Expert meetingAdvisory-board brief, slides, minutes, executive summary, or scientific reportPre-meeting objective, attribution, and post-meeting use
Non-specialist audiencePLS, trial-results summary, patient information, consent, leaflet, public communicationDecision need, legal context, literacy, and testing
Learning needCME/CE module, training deck, learning resourcePractice gap, objective, instructional format, and evaluation