Data Availability Policy

Data Sharing and Research Data Transparency Policy

The Journal of Pharmacovigilance and Drug Research (JPADR) supports transparency, reproducibility, and integrity in scientific research. Authors are encouraged to make research data available wherever ethically, legally, and practically possible to facilitate verification, reproducibility, and further scientific advancement.

JPADR follows the principles of open scientific communication and aligns its editorial practices with recommendations from the Committee on Publication Ethics (COPE), the International Committee of Medical Journal Editors (ICMJE), and internationally accepted standards for research integrity.

1. Purpose of the Policy

This policy aims to:

  • Promote transparency in scientific reporting.
  • Encourage reproducibility and validation of research findings.
  • Improve research integrity and accountability.
  • Facilitate responsible data sharing.
  • Support long-term preservation of scientific data.

Authors are encouraged to share data supporting the findings of their published work while respecting ethical, legal, privacy, and confidentiality obligations.

2. Data Availability Statement

All manuscripts submitted to JPADR should include a Data Availability Statement immediately before the References section.

The statement should clearly indicate:

  • Whether data are available.
  • Where the data can be accessed.
  • Conditions for access.
  • Reasons for any restrictions.

Examples of Data Availability Statements

A. Publicly Available Data

"The datasets generated and/or analyzed during the current study are available in the [repository name] repository at: [DOI or URL]."
B. Data Available on Request

"The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request."
C. Restricted Data

"The data are not publicly available due to patient confidentiality and institutional ethical restrictions."
D. No New Data Generated

"No new datasets were generated or analyzed during the current study."

3. Data Sharing Expectations

Authors are encouraged to share:

  • Raw data
  • Processed datasets
  • Statistical analysis files
  • Research protocols
  • Software code (where applicable)
  • Supplementary materials
  • Laboratory methods
  • Survey instruments
  • Pharmacovigilance datasets (where ethically permissible)

Shared data should be sufficiently detailed to permit:

  • Verification of findings.
  • Independent reanalysis.
  • Reproducibility of the study.

4. Reproducibility and Research Integrity

Authors should maintain accurate and complete records of:

  • Experimental procedures.
  • Data collection methods.
  • Statistical analyses.
  • Software tools used.
  • Data processing workflows.

Editors may request:

  • Original datasets.
  • Ethics approvals.
  • Laboratory records.
  • Statistical outputs.
  • Supporting documentation.
Failure to provide supporting data when requested may result in manuscript rejection, retraction of published articles, or notification to affiliated institutions where appropriate.

5. Recommended Data Repositories

Authors are encouraged to deposit datasets in recognized public repositories appropriate to their discipline.

Suitable repositories include:

  • Institutional repositories.
  • General repositories.
  • Subject-specific repositories.
  • Clinical trial repositories.

Examples include:

  • Zenodo
  • Figshare
  • Dryad
  • Open Science Framework (OSF)
  • Harvard Dataverse
  • ClinicalTrials.gov
  • WHO International Clinical Trials Registry Platform (ICTRP)

Datasets should preferably receive:

  • Persistent identifiers (e.g., DOI).
  • Stable repository links.
  • Appropriate metadata descriptions.

6. Raw Data Requests

JPADR reserves the right to request raw data during:

  • Editorial evaluation.
  • Peer review.
  • Post-publication investigations.

Authors should retain original data and supporting records for a reasonable period after publication in accordance with institutional or regulatory requirements and cooperate fully with legitimate verification requests.

7. Clinical Trial Data Transparency

For clinical trials and interventional studies, authors should:

  • Register the trial in a recognized public trial registry before participant enrollment.
  • Provide trial registration numbers within the manuscript.
  • Clearly disclose outcome measures and study protocols.
  • Report deviations from registered protocols where applicable.

Authors are encouraged to make de-identified participant-level data available whenever ethically and legally permissible.

JPADR supports transparency in:

  • Clinical trial reporting.
  • Safety reporting.
  • Pharmacovigilance data reporting.
  • Adverse event reporting.
Selective reporting or suppression of clinical trial results is considered unethical.

8. Ethical and Legal Considerations

Data sharing must comply with:

  • Patient confidentiality requirements.
  • Institutional ethics approvals.
  • Informed consent agreements.
  • National and international privacy regulations.

Personally identifiable information should never be publicly disclosed unless explicit informed consent has been obtained.

Where restrictions apply, authors should clearly explain these limitations within the Data Availability Statement.

9. Sensitive and Confidential Data

Certain datasets may require restricted access due to:

  • Patient privacy.
  • Commercial confidentiality.
  • Legal obligations.
  • National security concerns.
  • Intellectual property protections.

Where restrictions exist, authors should provide:

  • A justification for restricted access.
  • Conditions under which access may be granted.
  • Contact information for legitimate requests where feasible.

10. Data Citation

Authors are encouraged to cite publicly available datasets within the reference list using accepted citation formats.

Data citations should include:

  • Author(s).
  • Dataset title.
  • Repository name.
  • Year.
  • DOI or other persistent identifier.

Proper data citation promotes transparency and ensures appropriate recognition for data creators.

11. Artificial Intelligence and Generated Data

Authors using artificial intelligence (AI) or automated systems in data analysis, image generation, or manuscript preparation must:

  • Disclose such use transparently.
  • Describe the methodologies employed.
  • Ensure the accuracy and integrity of all generated outputs.

Authors remain fully responsible for all data, analyses, interpretations, and conclusions presented in their manuscript.

12. Editorial Assessment of Data Availability

Editors and reviewers may evaluate:

  • Adequacy of shared data.
  • Transparency of reporting.
  • Reproducibility of analyses.
  • Compliance with ethical standards.

Additional clarifications or supporting documentation may be requested before a manuscript proceeds to publication.

13. Non-Compliance with Data Availability Requirements

Failure to comply with this policy may result in:

  • Delay in editorial processing.
  • Manuscript rejection.
  • Publication correction.
  • Retraction of published articles.
  • Notification of affiliated institutions in serious cases.

JPADR follows guidance issued by the Committee on Publication Ethics (COPE) when addressing concerns relating to data integrity and reproducibility.

14. Commitment to Open and Responsible Science

JPADR encourages responsible data sharing practices that balance:

  • Scientific transparency.
  • Ethical obligations.
  • Participant confidentiality.
  • Legal requirements.
  • Research integrity.

The journal supports initiatives that strengthen reproducibility, openness, accountability, and public trust in scientific communication.

References

  1. Committee on Publication Ethics (COPE). Core Practices and Data Integrity Guidance.
  2. International Committee of Medical Journal Editors (ICMJE). Recommendations for Clinical Trial Registration and Data Sharing.
  3. World Health Organization (WHO). International Standards for Clinical Trial Registration and Reporting.