FDA Audit Readiness - ASCO

1 American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t: FDA Audi t Re a di nes s 1 TOOLKIT OF RESOURCES FDA Audit Readiness American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t: FDA Audi t Re a di nes s 2 Page Number Overview 3 FDA Inspections ASCO Research Community Forum At-A-Gl a nc e: FDA Inspections of Clinical Trials 5 Types of FDA Inspections 8 FDA Audi t Pr oc es s 9 Questions to Ask FDA 10 Sa mpl e FDA Form 482 11 Potential Audit Questions for Principal Investigator 12 FDA Inspection Preparation Checklist 15 FDA Inspection Site Summary 33 Si te Summa ry of Inspection 34 FDA Form 483 Do s and Don ts 36 Sa mpl e FDA Form 483 37 Sa mpl e Responses to FDA Form 483 38 Resources 42 TABLE OF CONTENTS American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t.

2 FDA Audi t Re a di nes s 3 This Toolkit was developed as part of an initiative led by the American Society of Clinical Oncology s Research Community Forum (ASCO RCF), which provides tools and resources to assist oncology research programs with conducting and managing clinical trials. It contains links to helpful references as well as templates, checklists, and forms related to FDA audits and Audit Readiness . This Toolkit was initially prepared for a workshop at the 2019 ASCO Research Community Forum Annual Meeting, When FDA Calls: Introduction to FDA Audit Readiness .

3 The references and resources are not exhaustive and decisions to include resources were based on the contributors own go-to resources, consultation with colleagues, and an environmental scan of available resources. Resources from commercial entities, or that are made available for profit, are generally excluded. The references are not necessarily endorsed by ASCO; they are listed based on the discretion and expertise of the contributors noted in the acknowledgements. If you have suggestions for additional resources for inclusion, please email them to ACKNOWLEDGEM ENTS There are several important contributors to this Toolkit, including: Andrea Buchmeier, MHA, CCRC, LSSGB from Sarah Cannon; Katie Goodman, RN, CCRC and James Reeves, MD from Florida Cancer Specialists; Susan Modugno, BSN, OCN, CCRC from Sarah Cannon Research Institute; Leslie Byatt, CPhT, CCRC from New Mexico Cancer Care Alliance.

4 And Aisha Peterson Johnson, MD, MPH, MBA from the US Food and Drug Administration. Some of the resources are adapted, with permission, from materials they or their colleagues at their affiliate organizations have developed to assist them with Audit Readiness . Patricia Hurley, MSc and Courtney Davis from ASCO s Center for Research and Analytics and the ASCO RCF also assisted with developing the toolkit. Disclaimer: This Toolkit contains templates and resources that are provided as examples only for research programs to consider as they formulate their own resources.

5 ASCO makes no warranties, expressed or implied, as to results obtained by individuals using the information and is not responsible for any action taken in reliance on the information contained herein. When citing this Toolkit, or any of its components, please include the following content in the citation: American Society of Clinical Oncology Research Community Forum Toolkit: FDA Audit Readiness . Alexandria, VA; American Society of Clinical Oncology; 2019. For more information contact OVERVIEW American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t: FDA Audi t Re a di nes s 4 FDA INSPECTIONS OF CLINICAL TRIALS American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t.

6 FDA Audi t Re a di nes s 5 KEY CONSIDERATIONS, TIPS, AND BEST PRACTICES Reasons for FDA Audits Top Reasons for an FDA inspection1 Common Deficiencies1 Risk based ranking of site Sites with a high number of enrollments Sites with known issues from previous inspections Concern with scientific misconduct, outliers, and protocol vi olations A compl aint a bout the PI or the s ite Failure to conduct an investigation in accordance with signed i nves tigator s tatement or a greement/investigational pl an/applicable regulations Inadequate or inaccurate case histories inadequate i nvestigator s ubject records Inadequate drug/device disposition records Failure to obtain informed consent in accordance with Part 50 When the FDA Critical Questions to ask the FDA Key Steps to Prepare for an FDA Inspection W h i c h s tu dy is under r eview?

7 Wha t type of a udit i s i t? What is the inspector s name? When would they like to visit? What is anticipated length of inspection? Who will be coming with inspector? W ha t r ec or ds will they r evi ew? Complete inspection preparation c h eck l is t Noti fy al l key s tudy s taff, s ponsor, and institutional official Pul l all original research records Review the protocol under inspection Revi ew a l l r eported s erious a dver se events Revi ew a l l pa rticipants c onsent for ms Revi ew a nd or ganize a ll regulatory documents I denti fy a quiet c onfer ence r oom for i nter view What to Expect Day of Inspection The Interview Dos and Don ts The Inspector Introduce themselves and show credentials Revi ew FDA for m 482.

8 Noti ce of i nspec tion, and give the i nvestigator the ori ginal form Review why the study is being inspected Review the inspection process and what to expect during the Audit Pr ovi de a pr ojected ti meline for the a udit Start the inspection by reviewing the regulatory binder, then move to informed consent and patient charts Conduct interviews with the investigator and s el ec t member s of r esear ch tea m Be c a l m - Don t be defens ive or get emoti onal Listen carefully and repeat the question - Ask for the question to be r epea ted or for c l arification Answer questions directl y, c ompletel y, a nd honestly.

9 I t i s fine to say I do not know. Do not guess or make up the answer Do not provide your opinion, only the facts Do not volunteer more information than necessary Do not a ns wer for s omeone el s e Ensure someone ta kes deta iled notes of the ques tions a sked Lea ve a s s oon a s the i nter view is over BOTTOM LINE A successful FDA inspection will lead to improved processes, improved communication, better training, and overall a higher quality research program. The following provides s ome s ugges ted best pr ac tices for r esearc h s ites to ens ure FDA a udit r eadiness.

10 A tool ki t i s also available a sc rch-commun ity-forum. FDA INSPECTIONS OF CLINICAL TRIALS AT A GLANCE KEEP CALM Conduct every study as if it will be inspected. Communicate with your team, study sponsor, FDA. Do not panic! Know the right questions to ask. Have an Audit plan and checklist ready. American Society of Clinical Oncology Research Community Forum Version: September 2019 ASCO Tool ki t: FDA Audi t Re a di nes s 6 After Inspection Follow-Up Conduc t a tea m meeti ng to r evi ew what went wel l a nd opportuniti es for i mpr ovement.