federal_register: 2013-22645

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2013-22645 Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Electronic Source Data in Clinical Investigations." This document provides guidance to sponsors, contract research organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. This guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission. 2013-09-18 2013 9 https://www.federalregister.gov/documents/2013/09/18/2013-22645/guidance-for-industry-on-electronic-source-data-in-clinical-investigations-availability https://www.govinfo.gov/content/pkg/FR-2013-09-18/pdf/2013-22645.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Electronic Source Data in Clinical Investigations." This document provides guidance to sponsors, contract research organizations (CROs), clinical...  

Links from other tables