14 Reporting Reporting Estimated reading: 1 minute 105 views Authors REP/01 Study report REP/01_01 Sample report EnglishDownload REP/01_02 Sample report GermanDownload REP/01_03 Requirements GLP reportDownload REP/02 Reporting on adverse eventsDownload REP/02-01 Text module CRFDownload REP/02-01 Text module CRFDownload REP/02-02 Report formDownload REP/02-03 Text module test planDownload REP/02-04 Report form UEs alternativeDownload Report a drug or medical device issue to the FDAFor the coding of Adverse Drug Reactions we use MedDRA Medical Dictionary for Regulatory Activities REP/03 Report to the Ethics CommitteeDownload REP/04-01 Sample of a clinical reportDownload REP/05 Report on dropout of a test personDownload REP/06 Final report following a clinical trialREP/07 Final report: Special features of the bioequivalence study Clinical Trial Manual - Previous 13 Statistics Next - Clinical Trial Manual 15 Arc archiving
