{"id":10974,"date":"2024-12-11T15:11:48","date_gmt":"2024-12-11T14:11:48","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/10-prc-process-control-prozesslenkung-monitoring\/"},"modified":"2025-02-04T13:38:01","modified_gmt":"2025-02-04T12:38:01","slug":"10-prc-process-control-process-control-monitoring","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/handbuch-klinische-pruefung\/10-prc-process-control-prozesslenkung-monitoring\/","title":{"rendered":"10 PRC Process Control Process Control Monitoring"},"content":{"rendered":"
PRC\/00 Process control<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/01 Clinical Trial Schedule Phase 1 Bioavailability<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/01-01 Flow sheet<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/02 Project management<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/02-01 Individual steps of project realisation<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/02-02 Clinical trial action plan<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/03 Notification of a clinical trial<\/a>Download<\/a><\/div>\n\n\n\n
PRC03-01 Cover letter authority<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/04 Deposit according to \u00a7 40 AMG<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/04-01 First submission form<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/05 Preparation of a clinical trial<\/a>Download<\/a><\/div>\n\n\n\n
PRC\/06 Scheduling<\/a>Download<\/a><\/div>\n\n\n\n
MON\/01 Tasks of the monitor<\/a>Download<\/a><\/div>\n\n\n\n
MON\/03 Selection of test centre<\/a>Download<\/a><\/div>\n\n\n\n
MON\/03-01 Test centre checklist<\/a>Download<\/a><\/div>\n\n\n\n
MON\/03-02 First contact checklist<\/a>Download<\/a><\/div>\n\n\n\n
MON\/03-03 Requirements for a test centre<\/a>Download<\/a><\/div>\n\n\n\n
MON\/04 Agreement with clinical investigator<\/a>Download<\/a><\/div>\n\n\n\n
MON\/04-01 Interview with clinical investigator<\/a>Download<\/a><\/div>\n\n\n\n
MON\/05 First visit to test centre<\/a>Download<\/a><\/div>\n\n\n\n
MON\/05-01 Discussion with employees<\/a>Download<\/a><\/div>\n\n\n\n
MON\/05-02 Inspection of documents at the test centre<\/a>Download<\/a><\/div>\n\n\n\n
MON\/06 Test sample request and forwarding<\/a>Download<\/a><\/div>\n\n\n\n
MON\/06-01 Delivery note test sample<\/a>Download<\/a><\/div>\n\n\n\n
MON\/07-01 Test sample certificate<\/a>Download<\/a><\/div>\n\n\n\n
MON\/07 Control of the whereabouts of test samples<\/a>Download<\/a><\/div>\n\n\n\n
MON\/08 Monitoring in the test centre<\/a>Download<\/a><\/div>\n\n\n\n
MON\/08-01 Memo<\/a>Download<\/a><\/div>\n\n\n\n
MON\/08-02 Monitoring checklist<\/a>Download<\/a><\/div>\n\n\n\n
MON\/08-03 Status sheet ongoing study<\/a>Download<\/a><\/div>\n\n\n\n
MON\/08-04 Table of test samples<\/a>Download<\/a><\/div>\n\n\n\n
MON\/08-05 Brief audit of test centre<\/a>Download<\/a><\/div>\n\n\n\n
MON\/09 Graduation<\/a>Download<\/a><\/div>\n\n\n\n
MON\/09-01 Final study meeting<\/a>Download<\/a><\/div>\n\n\n\n
MON\/09-02 Topics of discussion Final meeting<\/a>Download<\/a><\/div>\n\n\n\n
MON\/09-03 Archiving of test documentation<\/a>Download<\/a><\/div>\n\n\n\n

Attachments<\/h3>","protected":false},"excerpt":{"rendered":"

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