Preparing for an Audit 8-09
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Preparing for an Audit 8-09

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CTEO TIP SHEET | Preparing for an AuditUpon receiving Notification of an Audit Confirm all appropriate study team members are notified about the audit including the researchpharmacy (if applicable) For an external Audit: Notify the Quality Assurance Office for Clinical Trials (QACT), Office forHuman Research Studies (OHRS), DFCI Research Pharmacy (and other participating institutionssresearch pharmacies), and Clinical Trials Offices for all external audits.research pharmacies), and Clinical Trials Offices for all external audits. Site study coordinators are responsible for reserving a space for the auditors at their location.Preparing for an Audit Review Regulatory Binder for completeness and accuracy Gather the requested information for each participant selected, this can include the following:Participant Entry and eligibility materials including informed consentPre-therapy, on-study, and follow-up requirement documentationTTrreeaattmmeenntt aaddmmiinniissttrraattiioonn aanndd ddoossee mmooddiiffiiccaattiioonnssToxicities and reporting of adverse eventsResponse assessmentsData Collection FormsDrug accountability Review information gathered for completeness and accuracy Review and update IRB correspondence Scan CRFs for empty data fieldsDDuurriinngg tthhee AAuuddiitt Give the auditor access to the requested records at the predefined time and place Be available for questions and help locate missing informationTIP SHEET Preparing for an ...

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CTEO TIP SHEET | Preparing for an Audit Upon receiving Notification of an Audit  Confirm all appropriate study team members are notified about the audit including the research pharmacy (if applicable)  For an external Audit: Notify the Quality Assurance Office for Clinical Trials (QACT), Office for Human Research Studies (OHRS), DFCI Research Pharmacy (and other participating institutionss research pharmacies), and Clinical Trials Offices for all external audits.research pharmacies), and Clinical Trials Offices for all external audits.  Site study coordinators are responsible for reserving a space for the auditors at their location. Preparing for an Audit  Review Regulatory Binder for completeness and accuracy  Gather the requested information for each participant selected, this can include the following: Participant Entry and eligibility materials including informed consent Pre-therapy, on-study, and follow-up requirement documentation TTrreeaattmmeenntt aaddmmiinniissttrraattiioonn aanndd ddoossee mmooddiiffiiccaattiioonnss Toxicities and reporting of adverse events Response assessments Data Collection Forms Drug accountability  Review information gathered for completeness and accuracy  Review and update IRB correspondence  Scan CRFs for empty data fields DDuurriinngg tthhee AAuuddiitt  Give the auditor access to the requested records at the predefined time and place  Be available for questions and help locate missing information TIP SHEET Preparing for an Audit Updated August 2009 1 Helpful Hints  Refer to the “Eligibility”, “Subject Entry”, and “Required Data” sections in the protocol when reviewing participant records for accuracy and completeness  Create a “note-to-file” when there is a discrepancy that requires clarification in the record. Signn aanndd ddaattee aannyy ““nnoottee--ttoo--ffiillee””,, aanndd iinncclluuddee hhooww tthhee iinnffoorrmmaattiioonn wwaass oobbttaaiinneedd  Refer to CTEO Tip Sheet “FDA Audit Etiquette” for guidance on FDA audits Common Errors Problem Preventions Lack of documentation in source documents about  Ensure that the consent PROCESS is outliinneedd consent process in each participant file and that it describeess hhooww ccoonnsseenntt wwaass oobbttaaiinneedd Participant not re-consented with updated informed  If it has been determined that participanttss consent form need to be re-consented, make sure that you are using the most recent consent forrmm to obtain consent and don’t forget to document the re-consenting process in thedocument the re-consenting process in the participant file Missing dates or signatures of participant, parent,  Review and verify the consent form containsains or investigator all appropriate signatures and dates and explain any missing information adequateellyy in a note-to-file Adverse events not reported to study teams  Ensure that all adverse events are reporteedd to the appropriate individuals including sttuuddyy teams at other institutions (if you are the lead site) and the overall PI (if you are thee non-lead site) AAddvveerrssee eevveennttss nnoott rreeccoorrddeedd oonn CCRRFFss  EEnnssuurree tthhaatt AALLLL aaddvveerrssee eevveennttss aarree rreeppoorrtteedd on the appropriate CRFs in the time framee indicated in the protocol Reasons for missed or delayed doses not  Explanation must be recorded in source documented documentation if the treatment, as outlineedd in the protocol, was modified in any way.. This includes missed or delayed doses. TheThis includes missed or delayed doses. The explanation should include why the dose was was missed or delayed Treatment administration details not documented  The details of how the treatment was administered must be in source TIP SHEET Preparing for an Audit Updated August 2009 2 documentation and include (if appropriate)e) dose, route of administration, length of administration and any other pertinent information No documentation of treatment compliance for at  Ensure that the protocol is using an IRB home medication approved “Drug Diary” and educate participants to fill out accurately and bringg iitt with them to each study visit as well as annyy remaining pills. Have participant sign andd date each Drug Diary and keep in researchch file as source documentation Performance status not documented  Have the Investigator use the QACT Eligibility Check List to dictate an on-studyEligibility Check List to dictate an on-study note. This will ensure all eligibility criteriaia are appropriately documented including Performance status Procedures and/or labs completed outside of  Develop a system that allows you to keepp required time points track of date requirements for ALL study pprroocceedduurreess aanndd eennssuurree tthheeyy aarree oobbttaaiinneedd aatt the appropriate time points as dictated byy the protocol. TIP SHEET Preparing for an Audit Updated August 2009 3