more common and increaseef昀椀ciency, they do not allow forthis handwriting comparison.This has brought about the useof individual signature pages (seeDiagram 3). In this situation, themain DOA Log is electronic, witheach study member completingan individual signature page inhard copy, which is then 昀椀led ina central location.The clinical investigator mustcon昀椀rm their approval andoversight of delegation byinitialing or signing and datingeach entry on the DOA Log.Depending on the log requiredby the clinical research site/Sponsor, the clinical investigatormay sign/initial and date eachentry either only at the beginningof a staff member’s participationor at both the beginning andend of participation. Althoughlapses of days, weeks, ormonths in clinical investigatorinitial/signature and date havebeen noted, obtaining thisdocumentation prior to the staffperforming delegated duties isbest practice.Overall clinical investigatorauthorization is found at thebottom of each log, where theclinical investigator can sign priorto consenting the 昀椀rst subjector at the conclusion of thestudy, based on the processesof the clinical research site, theSponsor, and the log’s format.If the clinical investigator changesduring the study, a new DOA Logcan be created or the original logcan be revised.If a new log is created, the oldlog should be 昀椀nalized andretired by following these steps:•••Add stop dates to active staffObtain former clinicalinvestigator’s initial anddate for all entriesFormer clinical investigatorDiagram 3The clinical investigator must confirm their approval and oversight of delegashouldtheon the DOA Log.See Table1 (on nextpage)foranddatingcompleteeach entryDependingon thelog requiredby thauthorization昀椀eld,ifnotmoreinformationoncompletionSponsor, the clinical investigator may sign / initial and date each entry eitheralready doneof the DOA Log.staffmember’s participation or at boththe beginning and end of participation• weeks,Stop dateon oldinlogand investigator initial / signature and date have beeor monthsclinicalOur assessment of the moststart date on new logdocumentationpriortothestaffperformingdutiesis best practice.commondelegated昀椀ndings onreviewshould coincide with IRBof DOA Logs by monitors /con昀椀rmation of the clinicalauditorsOverallclinicalchangeinvestigator authorizationis is:found at the bottom of each log,investigatorinvestigator can sign prior to consentingthe firstsubjector at the conclusion• Studytaskshave beenIf processesthe currentofDOALogiskept:carriedoutbystaffthe clinical research site, the Sponsor, and thenotlog’s format.listed on the DOA Log• Strikethrough clinicalname at the• StafftasksIf investigator’sthe clinical investigatorchanges duringthebeingstudy,delegateda new DOALog can betopofeachpageandaddwithouttheappropriatecan be revised.the new clinical investigator’seducation, training, andlevelexperienceIf namea new log is created, the old log shouldbe offinalizedand retired by followi• New clinical investigator• Staff responsibilities areAddthestoplogdates to active staffshould reviewimproperly documentedObtainformerinitialand昀椀le,dateand sign/initialanddate clinical investigator’s• No DOA Logis onorfor all entriebeside theFormerpreviousclinical investigatorlogshouldcompletetheauthorizationfiis 昀椀led but blankclinical investigator’sStop date on old log and• startlog should coincide wLogdatehasonnotnewbeensignature/initials to con昀椀rmcompletedinatimelyclinical investigator changeacknowledgementmanner as staff changes• Create NTF to document the• Responsibilities or tasksIf detailsthe currentLogincludingis kept:of theDOAchange,are updated without anStrikethroughclinical investigator’sname at the top of each pagthe IRB approvaldateaudit trailinvestigator’s nameNew clinical investigator should review the log and sign / initialclinicalSOCRAinvestigator’ssignature/ initials toconfirm acknowledgSOURCE© November202441Create NTF to document the details of the change, including the
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