Society of Clinical Research Associates (SOCRA): Clinical Site Coordinator/Manager Workshop - PowerPoint Presentation

1. Society of Clinical Research Associates (SOCRA): Clinical Site Coordinator/Manager WorkshopNovember 9-10, 2017San Diego, CA Heather M. Quinlan-Baron, Grants Manager, Endocrinology February 26, 2018

2. What is The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia.

3. Incorporated in 1991, with local chapters across the U.S. and Canada, along with international chapters in Belgium, Brazil, Poland and Saudi ArabiaMembership includes conferences, workshops, a journal and online learningAnnual conference takes place in the Fall of each year Workshops on such topics as Clinical Investigators and GCP; Drug Development and Clinical Science; Project Management; and Advanced Site Management: Finance and Productivity Certified Clinical Research Professional (CCRP) programIndustry-recognized certification, with review course and examination offering

4. Why did I attend the Clinical Site Coordinator/Manager Workshop? Came from a research background before working at BU/BMC and hoping to become more involved with ongoing clinical trials in a research versus solely financial capacityWorking on developing a Clinical Trials Unit in our SectionExpand my knowledge regarding research study visit design and implementationBecome more familiar with the regulatory/IRB processStop bothering my colleague, Ashley McCarthy, all the time!

5. Workshop PresentersBoth research nurses and CCRP certified, with combined 62 years of clinical research experienceFrom Canada (Calgary and Toronto)One working for the Center for Addiction and Mental Health in Toronto, the other in an independent clinical research consulting organization Very knowledgeable, especially strong on GCP regulations, informed consent, and source documents

6. Workshop Attendees: 26 in total, with 2 presenters, and 3 SOCRA admin staff Most regions of the U.S. represented…West Coast: California, OregonSouthwest: Arizona, New MexicoMidwest: Michigan, Ohio, Missouri, Indiana South/Southeast: Texas, North CarolinaMid-Atlantic: Maryland Alas, only me from the Northeast! I was the farthest American traveler at the conference. Outside of U.S.Vancouver, BCToronto, ONSeoul, South Korea

7. Workshop Topics and Agenda The Regulatory EnvironmentGood Clinical Practice at the Research SiteInformed Consent ProcessSafety for the Research Subject Study ImplementationMonitoring VisitsAudits and InspectionsContinuous Quality Improvement

8. So, what exactly is GCP and why is it so important? Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected Major theme of the workshop and discussed throughout each topic

9. The Regulatory Environment Evolution of GCPExperimentation/research atrocities during WWII lead to Nuremberg Code in 1947Thalidomide (1959-1962) resulted in amendment to the FDA Cosmetics Act in 1962 Declaration of Helsinki: adopted in 1964, statement of ethical principles and guidance for physicians and others conducting researchTuskegee Syphilis study (1932-1972): subjects not informed of purpose of study, treatment deliberately withheldBelmont report (1979): informed consent, and special protection for those with diminished autonomyInternational Council on Harmonization (ICH): implemented in 1997, developed GCP guidelines that are in use today

10. Good Clinical Practice at the Research Site Guiding principles of clinical GCPDelegation log and other documentationInvestigational productResearch ethics boards

11. Informed Consent Process GCP for informed consentEnvironment and interpersonal factors that affect receiving consentIssues affecting information and understanding such as age, culture, learning style and languageDid an exercise on ICH guidelines for GCP of Informed Consent (Elements A-T) that was particularly helpfulTip sheet on drafting Informed Consent in my workbook is also a useful tool

12. Safety for the Research SubjectSafety reportingAdverse Events (AEs)Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment Serious Adverse Events (SAEs)Exercise determining if AE/SAE related to study participation

13. Study Implementation: Part 1 and 2Part 1Role of Study CoordinatorSteps for setting up the study…Review protocolEssential documentation collectionReview or complete budgetDevelop consent formComplete IRB submission Important: Getting whole staff involved, thank you gifts, roll-out breakfast/lunch celebration Part 2Once study has been implemented…Collecting informationCase report formSource documents/documentationElectronic dataHad exercise on visit monitoring notes

14. Monitoring Visits The role of site/study monitorHow to have a successful site visitFun skit on everything that can/could go wrong at a monitoring visit

15. Audits and InspectionsThe purpose of an audit/inspection is to evaluate the conduct of the trial and assess compliance with protocols, SOPs, GCP, and the applicable regulatory requirementsQuality management systemsQuality assuranceComplianceDocumentationTransparencyEthical conduct How to prepare for site audits and inspections

16. Continuous Quality Improvement “All improvement involves change, not all changes are improvement”Proactively assessing performance of the study teamHow to develop a Corrective Action/Preventive Action Plan (CAPA)The importance of Standard Operating Procedures (SOPs)

17. What else did I learn? Question to my fellow attendees: Do you charge PI salaries on your studies/trials? Answer was a resounding YES! They work in the negotiating stage to be sure salaries are covered appropriately, and begin charging salaries to accounts right away. Question to presenters/SOCRA organizers: As a newcomer to clinical trial research, what workshops would you recommend? The annual meeting does pre-conference workshops for beginners, that cover GCP, budgeting/finances, IRB and more. Would recommend that over taking additional workshops for newcomers. Question to presenter: We are in the starting phasing of proposing a clinical trial unit at our hospital, do you have resources available in that regard? Email us at anytime, and we can send you an outline/checklist of what you’ll need to get your program started

18. And finally…The workshop was great and glad I attended, but would definitely be interested in attending the beginner pre-conference workshops in the future. Would recommend membership to anyone working in clinical trialsSan Diego is a beautiful city with culture, history, and education…and 72 degree weather in November!Many thanks to the DOM Admin Professional Development grant, and the support of my Section, especially Administrative Director, Jen Fosbroke and Section Chief, Alan Farwell, for this opportunity