OBJECTIVES: Post-authorization interventional clinical trials (CT) and non-interventional clinical studies (NIS) are increasingly used to evaluate safety and other outcomes in real-world settings.  Previously, NIS clinical study report (CSR) templates used International Society for Pharmacoepidemiology (ISPE; www.pharmacoepi.org) reporting guidelines and/or were modified from International Conference on Harmonisation (ICH) E3 guidelines.  Resulting CSR templates may not have contained adequate instructions to develop CSRs for regulatory review and subsequent corresponding manuscripts.  We reviewed various published documents and developed robust NIS CSR templates for use in regulatory submission. METHODS: Guidelines reviewed included ISPE (based on FDA guidance and EU documents) and Guideline on Good Pharmacovigilance Practices – module VIII  (www.ema.europa.eu),  which describes post-authorization safety studies (PASS) and updated CSR guidelines,  following implementation of revised pharmacovigilance legislation in July 2012.  For NIS manuscripts, STROBE (STrengthening the Reporting of oBservational studies in Epidemiology) guidelines (www.strobe-statement.org) were reviewed.  We also reviewed other NIS-related documents, as well as interventional CT-related documents, including ICH CSR guidelines and CONSORT (CONsolidated Standards of Reporting Trials) or other design-specific guidelines (www.equator-network.org) for writing corresponding manuscripts.  Additional instructional and preferred/optional text was developed for the templates.  RESULTS: Overall, PASS guidelines provided additional NIS details and were aligned with most regulatory sections common in ISPE and aligned closely with STROBE statements.  ISPE guidelines provided few details for CSR template development.  Other guidelines and a literature review provided additional CSR template text and the inclusion of STROBE–based text supported development of manuscripts.  By utilizing multiple document sources, new templates were developed that contained improved instructions and text while meeting regulatory requirements.  Furthermore, decision trees were included to support the numerous types of NIS study designs. CONCLUSIONS: By aligning CSR guidelines with design-specific publication guidelines, template quality was improved for regulatory submissions and authors could easily identify important report content when writing peer-reviewed publications.