{"id":10982,"date":"2024-12-11T15:12:25","date_gmt":"2024-12-11T14:12:25","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/14-reporting-berichterstattung\/"},"modified":"2025-02-04T13:38:02","modified_gmt":"2025-02-04T12:38:02","slug":"14-reporting-reporting","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/14-reporting-berichterstattung\/","title":{"rendered":"14 Reporting Reporting"},"content":{"rendered":"

REP\/01 Study report<\/p>\n\n\n\n

REP\/01_01 Sample report English<\/a>Download<\/a><\/div>\n\n\n\n
REP\/01_02 Sample report German<\/a>Download<\/a><\/div>\n\n\n\n
REP\/01_03 Requirements GLP report<\/a>Download<\/a><\/div>\n\n\n\n
REP\/02 Reporting on adverse events<\/a>Download<\/a><\/div>\n\n\n\n
REP\/02-01 Text module CRF<\/a>Download<\/a><\/div>\n\n\n\n
REP\/02-01 Text module CRF<\/a>Download<\/a><\/div>\n\n\n\n
REP\/02-02 Report form<\/a>Download<\/a><\/div>\n\n\n\n
REP\/02-03 Text module test plan<\/a>Download<\/a><\/div>\n\n\n\n
REP\/02-04 Report form UEs alternative<\/a>Download<\/a><\/div>\n\n\n\n

Report a drug or medical device issue to the FDA<\/a>
For the coding of Adverse Drug Reactions we use MedDRA<\/a> Medical Dictionary for Regulatory Activities<\/p>\n\n\n\n

REP\/03 Report to the Ethics Committee<\/a>Download<\/a><\/div>\n\n\n\n
REP\/04-01 Sample of a clinical report<\/a>Download<\/a><\/div>\n\n\n\n
REP\/05 Report on dropout of a test person<\/a>Download<\/a><\/div>\n\n\n\n

REP\/06 Final report following a clinical trial
REP\/07 Final report: Special features of the bioequivalence study<\/p>\n\n\n\n

<\/p>","protected":false},"excerpt":{"rendered":"

REP\/01 Study Report Report of a drug or medical device issue to the FDAUse MedDRA Medical Dictionary for Regulatory Activities to code Adverse Drug Reactions REP\/06 Final Report after a Clinical TrialREP\/07 Final Report: Specifics of Bioequivalence Study<\/p>","protected":false},"author":1,"featured_media":0,"parent":10954,"menu_order":14,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10982","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10982","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=10982"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10982\/revisions"}],"predecessor-version":[{"id":15055,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10982\/revisions\/15055"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10954"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=10982"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10982"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}