Dossier patterns by document family

Every project includes a brief, governing material, working decisions, and the deliverable. The evidence roles differ.

Original clinical-research manuscript

Core sources commonly include the final protocol and amendments, statistical analysis plan, validated tables/figures/listings, clinical study report where available, registry information, and relevant literature. Add target-journal instructions, authorship and disclosure records, prior abstracts or presentations, and author input.

Questions to resolve:

• Which analyses are primary, secondary, sensitivity, subgroup, or exploratory?
• Which output version is authoritative?
• Which study population governs each result?
• Are manuscript claims consistent with the registry, CSR, and prior disclosures?
• Which results have already been published or presented?

Observational or real-world study manuscript

Add the study protocol or analysis plan, data-source description, cohort definitions, codebook, variable and outcome definitions, confounding strategy, missing-data approach, analysis outputs, and data-quality information. Literature should cover current knowledge and design-specific context.

Questions to resolve:

• How were patients, exposure, comparators, and outcomes identified?
• What is known about completeness, measurement error, and missingness?
• Which confounders were measured and adjusted, and which may remain?
• Does the language remain associative where causal inference is not justified?

Narrative review

The literature set is the core evidence. Include the review concept, audience, time and topic boundary, target, search notes, key and contradictory papers, clinical-practice context, and any author expertise used to shape interpretation.

Questions to resolve:

• What organizing problem does the review solve?
• How was coverage made balanced?
• Which sources are seminal, current, direct, or secondary?
• Is the method described honestly without implying systematic completeness?

Systematic review and meta-analysis

Include protocol or prespecified review plan, exact search strategies, dates and sources searched, deduplication record, screening decisions, exclusion reasons, included-study data, appraisal, extraction tables, synthesis plan, meta-analysis outputs where applicable, and flow information.

Questions to resolve:

• Can the search and selection process be reproduced?
• Are eligibility decisions consistent?
• Is study quality considered before synthesis?
• Are heterogeneity and limitations represented?
• Does statistical pooling have suitable specialist ownership?

Case report

Include the clinical record approved for use, chronology, diagnostic and treatment information, outcome and follow-up, relevant literature, patient consent documentation where applicable, privacy review, and target instructions.

Questions to resolve:

• What is the teaching or hypothesis-generating value?
• Which details are necessary and which increase identifiability without adding value?
• Does the conclusion stay inside the evidence of one case?

Congress abstract, poster, and oral presentation

Include the parent study sources, current analysis cutoff, validated outputs, target-congress instructions, prior disclosure status, author information, and the approved evidence interpretation. Posters and talks add visual assets and presentation constraints.

Questions to resolve:

• Are results final or interim?
• Which details must survive compression?
• Does the visual preserve scale, denominator, and uncertainty?
• Is the derivative consistent with the later or parallel manuscript?

Clinical protocol

Include development strategy, background evidence, product information, prior nonclinical and clinical findings, study concept, objectives and endpoints, design decisions, operational input, statistical input, safety monitoring, ethics requirements, data-management plans, and current template/guidance.

Questions to resolve:

• Does every objective have an endpoint, assessment, and analysis path?
• Are eligibility, treatment, safety, withdrawal, and follow-up operationally clear?
• Do amendments propagate to consent, registration, SAP, and related files?

Clinical study report

Include final protocol and amendments, final SAP, validated outputs, data-review and deviation information, patient narratives, exposure and disposition data, prior reports, and applicable template and guidance. A draft report or slide is context, not automatically the numerical authority.

Questions to resolve:

• What differed between plan and conduct?
• Are all objectives and endpoints accounted for?
• Do synopsis, body, tables, narratives, and appendices agree?
• Are safety interpretation and patient privacy under appropriate review?

Investigator's brochure and integrated regulatory summaries

Include current product identity, nonclinical and clinical reports, safety information, pharmacology and pharmacokinetics, prior versions, development decisions, and the current structural requirements. Integrated summaries add program-level study tables, cross-study analyses, and evaluative strategy.

Questions to resolve:

• What is new since the prior version?
• Which risks and uncertainties are material to investigators or reviewers?
• Are conclusions integrated across sources rather than copied from individual reports?

Safety documents

Include case data or aggregate outputs, exposure, safety database information, prior reports, reference safety information, coding and listedness context, signal evaluation, risk-management information, and current reporting instructions.

Questions to resolve:

• Is the case or aggregate period defined?
• Are dates, seriousness, outcome, causality, and coding reconciled?
• Is personal information limited to what the document needs?
• Which recurring conclusions changed, and why?

Device and IVD evidence work

Include device identity and intended purpose, classification and lifecycle context, prior plans/reports, clinical or performance evidence, state-of-the-art literature, risk-management material, investigations, post-market information, complaints and vigilance where applicable, labeling, and current regulatory framework.

Questions to resolve:

• Is every claim tied to the correct device configuration and intended purpose?
• Is the literature search reproducible and current enough for a living evaluation?
• Which linked plan or report changes when new evidence arrives?

HEOR, value, and HTA work

Include the decision problem, population, interventions and comparators, clinical and economic evidence, epidemiology, resource use, utilities, costs, model files, assumptions, scenarios, sensitivity analyses, jurisdictional methods, and payer template.

Questions to resolve:

• Which perspective and time horizon govern the result?
• Can every narrative claim be traced to evidence or a model input?
• Are uncertainty and scenario dependence clear?

Patient and public material

Include the authoritative scientific or regulatory source, intended-reader profile, user questions, glossary or terminology decisions, privacy constraints, applicable requirements, translation plan, visual assets, patient or public input, and user-testing results.

Questions to resolve:

• What decision or understanding does the reader need?
• Which scientific qualifications must survive simplification?
• What did intended users misunderstand?
• Does translation preserve meaning and cultural relevance?