Submissions

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Author Guidelines

Authors are invited to make a submission to Annals of Real-World Data & Evidence. All submissions will be assessed by an editor to determine whether they meet the aims and scope of this journal. Those considered to be a good fit will be sent for peer review before determining whether they will be accepted or rejected.

Before making a submission, authors are responsible for obtaining permission to publish any material included with the submission, such as photos, documents and datasets. All authors identified on the submission must consent to be identified as an author. Where appropriate, research should be approved by an appropriate ethics committee in accordance with the legal requirements of the study's country.

An editor may desk reject a submission if it does not meet minimum standards of quality. Before submitting, please ensure that the study design and research argument are structured and articulated properly. The title should be concise and the abstract should be able to stand on its own. This will increase the likelihood of reviewers agreeing to review the paper. When you're satisfied that your submission meets this standard, please follow the checklist below to prepare your submission.

Fast-Track AI-Assisted Review (Optional & Free) 

We offer an optional, transparent, AI-assisted fast-track process that reduces review time by 70% at no additional cost.

To utilize this:

  1. Obtain an AI evaluation of your manuscript at Evidence AI. 

  2. Have your Evidence AI Review file (without altering the file) ready to upload alongside your manuscript. 

  3. Use your Cover Letter to address any specific feedback provided by the AI. Please note that our human reviewers can override any comments provided by Evidence Ai.

Submission Preparation Checklist

All submissions must meet the following requirements.

  • This submission meets the requirements outlined in the Author Guidelines.
  • This submission has not been previously published, nor is it before another journal for consideration.
  • All references have been checked for accuracy and completeness.
  • All references are mentioned in Vancouver format at the end of the document, with reference numbers in brackets throughout the manuscript.
  • All tables and figures have been numbered and labeled.
  • Permission has been obtained to publish all photos, datasets and other material provided with this submission.

Original Research Articles

Full‑length, peer‑reviewed studies using real‑world data to generate clinical, regulatory, or policy‑relevant evidence. Manuscripts of up to 5,000 words must demonstrate methodological rigor, transparency, and appropriate analytical design. 

Study Protocols

Protocols for RWE studies, registries, data platforms, and analytical pipelines. Protocols must describe rationale, objectives, data sources, governance, methods, and planned analyses. Only publically verifiable peer-reviewed protocols are accepted. The peer-review shall be conducted by an independent committee such as EMA's Pharmacovigilance Assessment Committee (PRAC), the journal will then waiver the peer-review process and document the already conducted peer-review. The authors are requested to submit the proof of peer-review of the protocol along with its manuscript. This section does not have any word count limit.

Methods & Analytics

Methodological innovations, causal inference approaches, statistical frameworks, data quality methods, and analytical tools of up to 4,000 words relevant to real‑world data and evidence.

Data Resources & Networks

Descriptions of registries, databases, digital health platforms, and federated networks of up to 5,000 words. Must include governance, structure, data quality, linkage, and analytical readiness.

Reviews & Syntheses

Systematic reviews, scoping reviews, methodological syntheses, and state‑of‑the‑field overviews of up to 5,000 words. Must follow recognized review standards.

Perspectives & Commentaries

Invited or submitted expert viewpoints on emerging issues, regulatory developments, methodological debates, or conceptual advances in RWE of up to 1,000 words.

Guidelines & Standards

Consensus statements, methodological guidelines, reporting standards, best‑practice frameworks, and expert recommendations relevant to the design, conduct, analysis, and reporting of real‑world data and real‑world evidence studies. Submissions may originate from professional societies, working groups, regulatory collaborations, or expert panels. All guidelines must demonstrate methodological rigor, transparency, and broad applicability.
Both invited and submitted guidelines are considered. No word limit is imposed.

Tools, Software & Applications

Concise, practical descriptions of tools, software platforms, analytical applications, algorithms, dashboards, and products relevant to real‑world data and real‑world evidence generation. Submissions of up to 1,000 words may include demonstrations, feature overviews, use cases, workflows, or implementation notes. These contributions are not peer‑reviewed but undergo editorial screening for clarity, relevance, and accuracy. Commercial products must include transparent disclosure of funding or affiliations.

Editorials

Invited pieces of up to 1000 words from the Editor‑in‑Chief or guest editors introducing issues, discussing field developments, or framing special topics.

Special Issues & Supplements

Themed collections or sponsored supplements. All scientific content undergoes full peer review; sponsorship is transparently disclosed.

Short Communications

Concise reports of early findings, methodological notes, or rapid insights of up to 1000 words.

Letters to the Editor

Short scholarly responses to previously published ARWDE articles of up to 500 words.

Copyright Notice

Authors who publish with Annals of Real-World Data & Evidence (ARWDE) agree to the following terms:

  1. Copyright Ownership: Authors retain copyright of their work. Upon acceptance, authors grant ARWDE a non-exclusive license to publish, distribute, and archive the submission in all formats and media.

  2. License to Publish: By submitting, authors confirm that the manuscript is original, does not infringe on any third-party rights, and has not been published elsewhere. Authors grant ARWDE the right to make the work publicly available under the terms of the selected license.

  3. Open Access and Licensing: All articles are published open access under a Creative Commons Attribution License (CC BY 4.0) (creativecommons.org in Bing), unless otherwise specified. This permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

  4. Author Responsibilities: Authors are responsible for obtaining permission to use any third-party material included in their submission and must disclose any conflicts of interest.

  5. Archiving and Indexing: ARWDE reserves the right to deposit published articles in institutional repositories, indexing services, and digital archives to ensure long-term accessibility.

Privacy Statement

The Annals of Real-World Data & Evidence (ARWDE) is committed to protecting the privacy of its authors, reviewers, and readers in accordance with the General Data Protection Regulation (GDPR/RGPD). The journal is published by the Elixir Institute, a brand of Toussilver SAS (the Data Controller).

1. Data Collection and Purpose

The personal data collected (names, affiliations, email addresses, and ORCID iDs) is used solely for the standard functioning of a peer-reviewed scholarly journal, including:

  • Editorial Workflow: Managing manuscript submissions, peer review, and publication.

  • Communication: Notifying authors and reviewers of status updates or editorial decisions.

  • Dissemination: Displaying author metadata alongside published articles for indexing and citation purposes.

2. Legal Basis for Processing

We process your data based on the performance of a contract (facilitating the publication process) and our legitimate interest in maintaining the integrity and transparency of the scientific record.

3. Data Retention and Third Parties

  • Permanence of Record: Author metadata (name and affiliation) remains part of the permanent scientific record upon publication to ensure academic accountability.

  • Service Providers: Data is shared only with essential services required for scholarly publishing, such as DOI registration (Crossref), indexing services (e.g., PubMed, Google Scholar), and digital archiving (LOCKSS/CLOCKSS).

  • No Commercial Sharing: We do not sell or share your personal data with third parties for marketing purposes.

4. Security and Hosting

Your data is stored on secure servers with industry-standard encryption. As our hosting services may be global, we ensure that all data transfers comply with standard contractual clauses for international data protection.

5. Your Rights (GDPR)

Under the GDPR, you have the right to:

  • Access and Rectify: View or correct your personal data.

  • Erasure: Request the deletion of your account (the "Right to be Forgotten"), provided it does not conflict with the integrity of already published scholarly work.

  • Object/Restrict: Limit how your data is processed.

To exercise these rights or to contact our Data Protection Officer, please email: contact@arwde.org.