{"id":10972,"date":"2024-12-11T15:11:39","date_gmt":"2024-12-11T14:11:39","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/9-pro-protocol-pruefplanung\/"},"modified":"2025-02-04T13:38:00","modified_gmt":"2025-02-04T12:38:00","slug":"9-per-protocol-test-planning","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/9-pro-protocol-pruefplanung\/","title":{"rendered":"9 Pro Protocol test planning"},"content":{"rendered":"
PRO\/01 Contract review<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/02 Test design<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/05 Data collection and description of active ingredients<\/a>Download<\/a><\/div>\n\n\n\n
Pro\/06 Exchange of information between clinical pharmacologist and head of clinical trial<\/a>Download<\/a><\/div>\n\n\n\n

PRO\/08 Timetable<\/p>\n\n\n\n

PRO\/09 Creation and approval of a test plan<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/09-01 Form for test plan<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/10 Modification of a test plan<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/10-01 Amendments to a test plan<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/11 Investigator's Brochure<\/a>Download<\/a><\/div>\n\n\n\n

PRO\/11-01 Table of contents investigagor brochure<\/p>\n\n\n\n

PRO\/12 Creating and maintaining a checklist (CRF)<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/12-01 CRF sample<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/13 Preparation of information sheet and declaration of consent<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/13-01 Sample information sheet<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/13-02_ Declaration of consent<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/13-03 Sample consent for radioactive substance<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/14 Study plan<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/15 Obtain ethics vote<\/a>Download<\/a><\/div>\n\n\n\n
PRO\/15-01 Cover letter Ethics Committee<\/a>Download<\/a><\/div>\n\n\n\n

PRO\/16 Entry in the Clinical Trials Register<\/p>\n\n\n\n

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

PRO\/08 Timetable PRO\/11-01 Table of contents investigator brochure PRO\/16 Registration in Clinical Trials Register<\/p>","protected":false},"author":1,"featured_media":0,"parent":10954,"menu_order":9,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10972","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\/10972","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=10972"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10972\/revisions"}],"predecessor-version":[{"id":15049,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10972\/revisions\/15049"}],"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=10972"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10972"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}