2.A Checklist of Important Points in Research Using JADER

Author:

SAKAI Takamasa1

Affiliation:

1. Drug Informatics, Faculty of Pharmacy, Meijo University, Japan

Publisher

Japanese Society for Pharmacoepidemiology

Subject

General Medicine

Reference13 articles.

1. 1) Paludetto MN, Olivier-Abbal P, Montastruc JL. Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France? Pharmacoepidemiol Drug Saf 2012;21:1289-94. doi:10.1002/pds.3333.

2. 4) European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module Ⅸ (Rev.1). [https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf (accessed 2020-8-30)]

3. 5) Food and Drug Administration. Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.[https://www.fda.gov/files/drugs/published/Good-Pharmacovigilance-Practices-and-Pharmacoepidemiologic-Assessment-March-2005.pdf (accessed 2020-8-30)]

4. 6) Schulz KF, Altman DG, Moher D;CONSORT Group. CONSORT 2010 statement:updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. doi:10.1136/bmj.c332.

5. 7) Vandenbroucke JP, von Elm E, Altman DG, et al. the STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE):explanation and elaboration. Int J Surg 2014;12:1500-24. doi:10.1016/j.ijsu.2014.07.014.

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