Talk:Study Data Reviewer's Guide

From PHUSE Wiki
Jump to: navigation, search

Ongoing Feedback on v1.0 of the Study Data Reviewer's Guide

Celgene has reviewed the SDRG and has one comment about the use of blue font in the headings. The FDA Portable Document Format (pdf) Specifications, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf states "Black is the recommended font color except that blue can be used for hypertext links." We asked edata@fda.hhs.gov to comment on this issue, and this was their response. "If the SDRG is used in providing documentation for an NDA/BLA, it is appropriate that the pdf submission follow the FDA's specifications ... i.e., the pdf document should not to use the blue font." We will be implementing the SDRG at Celgene but will change the blue header fonts to black. We thought the PhUSE SDRG team would like to have this information. Anne Russotto Senior Manager, Clinical Data Standards Celgene

Naming convention for SDRG -- Manolya (talk) 05:36, 17 November 2016 (CST)

The naming convention as per Reviewer's Guide is "study-data-reviewers-guide". The last updated FDA conformance Guide (v3.2 October 2016) now says that the SDRG should be named as "cSDRG.pdf" for clinical submission, and "nSDRG.pdf" for non-clinical submission. But we can still use the last naming convention, I suppose? Is there an update for the SDRG Guideline in the near future?