Clinical Research Training Specialists

Transcription

1 Cliical Research Traiig Specialists Hero Bay Blvd, Ste 102, Coral Sprigs, FL Ph: (877) Fax: (800) Website: MRMCourse Catalog CRA Traiig 140 Hour CRA Certificate Program Fudametals of Cliical Research Oe-, Two- ad Three-day Cliical Research Semiars - Advaced Quality Moitorig - Coordiatig a Cliical Trial - Drug/Biologic GCP ad Moitorig - Medical Device GCP ad Moitorig - Writig Professioal Moitorig Reports Cliical Research E-Learig - Ivestigator s Traiig Program - Coordiator s Traiig Program - HIPAA Privacy Rule - GCP from the Ivestigator s Perspective Visit website to see expadig elearig library

2 Medical Research Maagemet - Who We Are MRM is oe of the atio s leadig providers of cliical research educatio ad customized traiig to leadig CROs; Pharmaceutical, Medical Device, ad Biotechology Compaies; ad Research Sites ad Uiversities. May Compaies are curretly usig MRM s e-learig courses as a requiremet for ew employees or ogoig GCP/ICH traiig. Sice 1999, Medical Research Maagemet Ic. (MRM) has offered the course Fudametals of Cliical Research, a 140 Hour CRA Certificate program, successfully graduatig thousads of professioals. This program is desiged for the professioal who wats to trasitio ito a CRA positio or eter the cliical research idustry. It offers comprehesive Educatio ad Hads-O Traiig of the cliical research process, the FDA regulatios, GCP (Good Cliical Practice), ad the Iteratioal Coferece of Harmoizatio (ICH) guidelies. MRM assists graduates of Fudametals with résumé preparatio ad job placemet ad also offers Employers complimetary job postig to our Alumi ad access to our résumé database. Jill Matzat, RN, BSN, Certified CRA ad ACRP Credetialed Cliical Research Traier. Course Desiger & Fouder Jill Matzat holds a Bachelor of Sciece i Biochemistry from the State Uiversity of New York at Stoy Brook, as well as a Bachelor of Sciece i Nursig from Barry Uiversity i Florida. She has over two decades of cliical research experiece icludig all aspects of moitorig ad maagig cliical trials, ivestigator recruitmet, cliical ivestigatioal plas, regulatory strategy, IDE / HDE / IND submissios, report developmet, protocol ad CRF developmet, SOP writig, developmet of study specific educatioal materials, ad project maagemet. Her experiece icludes biologics, drugs, devices ad combiatio products. I 1998, Jill fouded Medical Research Maagemet, Ic. ad developed Fudametals of Cliical Research. She is also oe of the fouders of a Cotract Research Orgaizatio, CRA Solutios, Ic. ( that curretly offers cosultig services to Medical Device, Pharmaceutical, ad Biotechology compaies iteratioally i the capacity of project maagemet ad moitorig. Jill is a frequet guest speaker at cofereces ad semiars. She addressed a coferece sposored by the Office of Huma Rights Protectio ad is a guest speaker at MAGI ad the ACRP Aual Coferece. She had Cliical Adjuct Faculty status at Vaderbilt Uiversity from Jill is a former Chairperso of the ACRP Traier s Forum ad was a member of the Govermet Relatios Committee, Govermet Affairs Committee, Cotet Expert Subcommittee, ad former member of Educatio. aboutus What Is A Cliical Research Associate (CRA)? A Cliical Research Associate, also kow as a Moitor, oversees the progress ad coduct of a cliical trial usually implemeted by physicias at a hospital, cliic, or physicia s office. The CRA is required to oversee the iitiatio, progress, ad coduct of the trial to esure the itegrity of the scietific data collected, i additio to protectig the rights, safety, ad well-beig of the huma study subjects. The CRA s resposibilities iclude, but are ot limited to, the followig: Moitorig the physicia s adherece to Good Cliical Practices ad the study protocol. Performig study drug accoutability. Verifyig the documetatio of the iformed coset process for each study subject. Esurig that o-serious ad serious adverse experieces are properly documeted ad reported. Comparig the case report form to the subject s medical record to assure completeess ad accuracy. Esurig the filig ad maiteace of the required regulatory documets. CRA s ofte have a health care or sciece backgroud (e.g. urse, medical techologist, or physical therapist; or Bachelor s, Masters, or a Ph.D. i a sciece). The CRA is usually employed by a pharmaceutical compay, cotract research orgaizatio, academic istitutio, or site maagemet orgaizatio. A CRA ca work either ihouse or i the field, requirig 50-70% travel. A field moitor will visit multiple sites ad iteracts with the study coordiator ad the ivestigator coductig the trial. T A B L E O F C O N T E N T S 140 Hour CRA Certificate Program table of otets Fudametals of Cliical Research...page 3 Fudametals of Cliical Research, a iteractive atiowide program providig olie ad two weeks, 70 hours, of hads o classroom traiig for the cliical research professioal. It begis with the history of legislatio ad regulatios that gover cliical research ad a overview of moitorig reports, drug, biologic, ad device developmet. Course participats develop a thorough kowledge base of Good Cliical Practices ad Iteratioal Coferece of Harmoizatio guidelies (E6, E2A), gaiig a solid uderstadig of cliical trial developmet ad maagemet. Durig Part Two, participats lear the MRM Step-Moitorig Method, a methodical, stadardized approach to moitorig, that icreases efficiecy ad accuracy. MRM also teaches the soft skills. It begis with beig a CRA ad how to write moitor reports. Fudametals of Cliical Research is oe of the oly kow courses that offers ALL of the followig: Extesive Cliical Research Educatio, icludig device ad drugs/biologic regulatios (see curriculum). Two weeks Hads-O Traiig for CRA, ad related professios. Assistace with Job Placemet ad Résumé Preparatio. (Oly for participats ot sposored by their Compay). Three tests: Moitorig Competecy Exam FDA GCP / ICH GCP Exam Successful completio of the 140 Hour Program is depedet o passig the two MRM exams. 2 MRM Step Moitorig Method Natiowide E Learig Olie Courses & Comprehesive Traiig... page 5 Semiars 1-, 2-, & 3-Day Semiars...page 6 Target Audiece: Cliical Research Professioals i the Device, Drug, ad Biologic Idustry. Semiars: Advaced Quality Moitorig Coordiatig a Cliical Trial Drugs/Biologics GCP & Moitorig Medical Devices GCP & Moitorig Writig Professioal Moitorig Reports These iteractive, hads-o traiig semiars are held i Coral Sprigs, Florida. Each semiar provides cotiuig educatio cotact hours that ca be applied to RN licesure ad ACRP / SoCRA Certificatio. Visit our website at for the latest semiars. Please visit our website: or Call toll free (877) for iformatio

3 Fudametals of Cliical Research 140 Hour CRA Certificate Program Course Structure CRA C e r t i f i c a t e Course Objectives: The participat will be able to: 1. Describe the medical product path startig with discovery ad edig with marketig approval. 2. Idetify the GCP obligatios i protectig the rights of study subjects. 3. Distiguish the differet roles ad GCP obligatios betwee the Ivestigator, Sposor, ad IRB. fudametals Fudametals of Cliical Research cosists of two parts: Part 1 / Educatio (Olie Course) The Part 1 Educatio cosists of a comprehesive olie course coverig chapters oe through seve (see curriculum o page 4). Available at ay time ad completed at the studet s desired pace ad schedule. Requires passig each chapter quiz prior to advacig to the ext chapter. The studet must complete ad pass all seve chapter quizzes before attedig the Part 2 Traiig class. Estimated completio time: hours. Free Demo available o web site: Prepares for the Core Kowledge Assessmet offered by ACRP. Olie Course Assistace is available. Cadidate Requiremets Applicats for the Cliical Research Associate Traiig Program are recommeded to have oe of the followig: Bachelor s, Masters, or a Ph.D. i a Sciece or Allied Health Field OR Healthcare Professioal (e.g. RN, PA, MD, PT, RPh, PharmD, or Medical Techologist) Criteria for Course Completio Comprehesive cumulative core kowledge exam to validate theolie educatio, based o Chapters 1 through 7 with a miimumscore of 70%. Moitorig competecy exam measured by moitorig a subject scase history ad the ivestigator study file idetifyig a miimum of80% deficiecies. GCP Regulatory/ICH Guidelie exam with a miimum score of 70%. The cadidate will receive a certificate of completio as a Cliical ResearchProfessioal, i additio to aother certificate of recogitio for passig thegcp Regulatory/ICH Guidelie exam. 4. Explai the ideal elemets used i coordiatig a cliical trial 5. Demostrate the ability to perform moitorig ad coordiatig activities ad detect GCP deficiecies. 6. Choose the differet problem-solvig techiques i resolvig GCP deficiecies. Part 2 / Traiig (Classroom Settig) The Part 2 Traiig sessio requires two cosecutive weeks of classroom attedace, Moday through Friday 9:30 to 5:30 PM, times may vary based o locatio. This sessio applies the kowledge acquired from the olie course utilizig case studies, traiig exercises, ad group discussios. Perform moitorig activities applyig the MRM Step Moitorig Method. Moitorig of six study subjects ad three Ivestigator Study Files across two therapeutic areas. Resolvig GCP related issues via Corrective Actio ad Prevetative Actio (CAPA) to secure compliace. Writig professioal ad effective moitorig reports to documet the securig of GCP compliace. Discussios o the differeces betwee drug/biologic versus medical device studies. Natiowide locatios. Résumé preparatio ad job placemet assistace program. (Does ot apply to employer-sposored studets.) Prerequisite: Part 1 Fudametals Educatio olie course. Scholarship Drawig! Eter olie cotest to receive a $1,500 tuitio reductio. Radom drawigs held mothly. See website for details. Registratio ad Fees Cost of the Cliical Research Associate Educatio ad Traiig Program is $3,495. $1,995 is required for Part 1. This provides the applicat with access to the olie course. The Fudametals of Cliical Research textbook ad course materials are set via express mail. $1,500 is due o, or prior to, the Part 2 startig date. Volume Discouts startig at Three or More Registratios Part Two Locatio Schedule February 1-12, 2016 April 11-22, 2016 May 16-27, 2016 September 12-23, 2016 November 7-18, 2016 Coral Sprigs, FL Philadelphia, PA Coral Sprigs, FL Parsippay, NJ Coral Sprigs, FL Paymet methods iclude check or credit card (MasterCard, Visa, America Express, ad Discover). Applicat may mail or fax the applicatio, or apply by phoe at (877) Please visit our website: or Call toll free (877) for iformatio 3

4 Part 1 - Fudametals Olie Educatio Curriculum fudametals 1. Food ad Drug Admiistratio Past ad Preset The Establishmet of the Food ad Drug Admiistratio. The History of the Legislatio ad Regulatios, which Gover the Cliical Research Process. The History of the Legislatio ad Regulatios, which Protect the Rights, Safety, ad Well-Beig of Huma Subjects. 2. Overview of Medicial Product Research ad Developmet Drug Discovery ad Pre-Cliical Research. The Cliical Research ad New Drug Applicatio Approval Process. The Biologics Research, Developmet, ad Licesig Process. Medical Device Research, Developmet, ad Marketig Approval/ Clearace. 3. Good Cliical Practice (GCP) Ivestigatioal New Drug Applicatio 21 CFR 312: Sposor s Obligatios. Ivestigatioal New Drug Applicatio 21 CFR 312: Ivestigator s Obligatios. Ivestigatioal Device Exemptio 21CFR 812. Istitutioal Review Boards 21 CFR 56. Protectio of Huma Subjects 21 CFR 50. Fiacial Disclosure 21 CFR Iteratioal Coferece of Harmoizatio The History of the Iteratioal Coferece of Harmoizatio. The ICH Good Cliical Practice Cosolidated Guidelie (E6). The ICH Cliical Safety Data Guidelie (E2). 5. Cliical Trial Developmet Protocol Desig ad Developmet Case Report Form Desig ad Developmet Pricipals of Data Maagemet ad the Query Resolutio Process The Study Types Providig Expaded Access to Ivestigatioal Products 6. Cliical Trial Maagemet Ivestigator Site Perspective: Coordiatig a Cliical Trial at the Site Essetials of Source Documetatio. Maitaiig ad Maagig Essetial Documets. Recordig ad Reportig No-Serious ad Serious Adverse Evets. Sposor s Perspective: Maagig a Cliical Trial Electig Ivestigators ad Moitors. Maitaiig ad Maagig Essetial Documets (e.g. FDA Form 1572). Case Report Form Data Trasmissio ad Geeratio of the Cliical Study Report. Reviewig ad Reportig of Serious Uexpected Adverse Drug Experieces. Implemetig a Moitorig Pla ad Performig Quality Assurace Audits. Preparig for a FDA Audit. 7. Moitorig Obligatios ad Methods Moitorig Role ad Resposibilities Accordig to the FDA Guidelie ad the ICH GCP (E6) Guidelie. Moitorig Resposibilities: Type of Moitorig Visits, Moitorig Activities Pre- Visit, O-Site, ad Post Visit. MRM Step Moitorig Method: Implemetig a Systematic Moitorig Approach to Effectively Moitor a Multi-Ceter Trial. Problem Solvig ad Trouble Shootig GCP / ICH Issues. Writig Strategic Moitorig Reports ad Follow-Up Visit Letters. Electroic Data Capture ad 21 CFR 11. Fudametals Part 1 Course Materials: Fudametals Course Maual Referece Materials CE s Registered Nurses will receive 70 cotiuig educatio credits upo successful completio of the course. FL State Provider # CA State Provider # CEP Please visit our website: or Call toll free (877) for iformatio

5 Part 2 - Fudametals Career Assistace Alumi Career Ceter After course completio, MRM s web-based Alumi Career Ceter will serve as a ogoig career guide ad resource. Access to job postigs. Liks to potetial employer web sites for résumé submissio. Idustry ews ad career iformatio. Access to moitorig tools ad templates are available for graduates. Alumi résumés are etered ito a database usig Résumé Wizard. They are the accessible to over 1,000 prospective employers. Résumé ad Job Placemet Please ote that job placemet assistace is ot available for employer sposored studets. Studets are provided with a résumé writig guidelie. Studets have their résumé evaluated by experieced Cliical Research Professioals. Successful graduates have their résumé distributed to hudreds of potetial employers (pharmaceutical compaies, cotract research orgaizatios, academic istitutios, ad research sites). Résumés will be posted o MRM s website for free access by employers. Graduates have access to job postigs ad career guidace through the ew Alumi Career Ceter. E-Learig e-learig Courseware Desig & Developmet The courseware is desiged to maximize the e-learig experiece ad icludes the followig: Pre-examiatio to evaluate the learer s Skills, Kowledge or Attitude (SKA) prior to traiig. Cotet ad layout strategies iclude behavioral learig objectives, key terms, diagrams, flow charts, ad tables highlightig key poits, example documets, workbook activities ad examiatio review guides. The learer has access to examiatio review guides prior to takig the post exam. Post examiatio to evaluate the learer s Skills, Kowledge or Attitude (SKA) acquired from traiig. The post examiatios provide feedback with correct ad icorrect aswers. The learer evaluates if the course has met each behavioral learig objective. Icorporates applicable parts of 21 CFR 11 with respect to traiig records, course access, ad security. Lear the methods of complyig with GCP from the Ivestigator's perspective. CEs are available for RNs ad may be applied to ACRP / SoCRA certificatio. E-Learig modules also available for as low as $200. Please visit our website at for more iformatio. Check website for MRM Moitorig Tools that are available for purchase. Please visit our website: or Call toll free (877) for iformatio Ivestigator Traiig Program $445 Lear the roles that the Ivestigator, Moitor, Coordiator, ad Sposor play i the cliical trial process; the methods ad strategies used to coduct the ideal cliical trial; kow the regulatios goverig cliical trials; ad list the steps ivolved i the ivestigator s assessmet ad reportig AEs ad SAEs. Complyig with the HIPAA Privacy Rule i Research $245 Discuss the covered etity s HIPAA requiremets ad its research impact with respect to the Notice of Privacy Practices, Access to Medical Records, ad Busiess Associates; list the permitted use ad disclosure of protected health iformatio without a idividual s authorizatio; ad discuss the steps ecessary to prepare ad coduct a HIPAA-compliat trial from the ivestigator ad sposor of CRO s perspective. A Coordiator s Guide to Coductig Cliical Research $295 Describe the role that the Coordiator, Ivestigator, Moitor, ad Sposor play i the cliical research process; discuss ad idetify the regulatios goverig a cliical trial, ad recogize the methods ad strategies used to coduct the ideal cliical trial. GCP From The Ivestigator s Perspective $200 Course Fees start as low as $ 250 per course, per user. Lear the methods of complyig with GCP from the Ivestigator s perspective. 5

6 semiars Semiars Advaced Quality Moitorig Course Descriptio: This three-day semiar is the startig poit for quality moitorig is a systematic approach that icludes the CRA s orgaizatio ad applicatio of methods to facilitate stadardizatio ad assessmet, complyig with GCP, ICH, ad HIPAA. Developig moitorig skills ivolves learig valuable time maagemet tips ad acquirig tools that facilitate cosistecy i performig the resposibilities of a CRA. The studet will lear how to write professioal ad effective moitorig reports ad follow-up visit correspodece. This 3-day course is ehaced by the hads-o traiig that utilizes simulated case studies, a ivestigator study file, ad report writig exercises. These techiques ca be applied to all studies whether they are drug, device, or biologic. Course Fee: $1, * CE Hours Coordiatig a Cliical Trial Course Descriptio: This two-day course is desiged to provide a brief overview of cliical research with a comprehesive review of FDA GCP ad ICH GCP (E6) ad the fudametal elemets ivolved i coordiatig a cliical trial. It provides practical tips ad suggestios that ca be applied to promote a GCP ad HIPAA compliat cliical trial, icludig prevetative measures ad problem solvig techiques of some of the most commo GCP o-compliace issues. Course Fee: $995 11* CE Hours Medical Device GCP ad Moitorig Course Descriptio: This 2-day semiar is desiged for those who desire a uderstadig of the device approval process, the regulatios that gover IDE studies ad the CRA s role i moitorig. The course cosists of a comprehesive overview of the medical device developmet process ad the GCP obligatios of the sposor, ivestigator, ad IRB; icludig the regulatory documets, study documets, ad device accoutability. A comprehesive review of the role ad resposibilities of the moitor, the type of site visits, ad a discussio o example FDA audit fidigs. Course Fee: $995 11* CE Hours Florida State Provider # / Califoria State Provider # CEP *Cotiuig educatio credits are available for RN s ad may be applied to ACRP / SoCRA certificatio. All are i Coral Sprigs, FL Dates: March 16-18, 2016 October 13-15, 2016 Dates: May 5-6, 2016 Dates: March 10-11, 2016 October New semiars are comig soo!! Go to to see the latest courses ad dates. 6 6 Please visit our website: or Call toll free (877) for iformatio

7 CRA Solutios, Ic. is a full sevice Cotract Research Orgaizatio (CRO) providig cosultig ad CRA services to the Medical Device, Biotechology, ad Pharmaceutical Compaies. CRA Solutios has a strategic alliace with a Europea CRO to offer its services o a global scale. Our orgaizatio was fouded i 2000 by Jill Matzat. RN, BSN, CCRA, CCRT ad is female-owed ad ower-maaged, providig persoalized attetio ad commuicatio to meet our customers eeds. CRA Solutios is able to offer focus, flexibility ad a rapid respose time that will please the most discerig cliet. Some of the services offered iclude the followig: Medical Devices, Combiatio Products, Biologics, ad Pharmaceutical Studies (All Phases) Study Feasibility Assessmets ad Gap Aalysis Cliical Ivestigatioal Pla/Protocol Developmet i Compliace with Iteratioal Stadards Case Report Form Developmet Set Up ad Atted Pre-IDE ad IND Meetigs FDA Strategy ad Regulatory Submissios Complete Study ad Project Maagemet All Aspects of Site Moitorig Usig the MRM Step Moitorig Method Subject Recruitmet Strategies Ivestigator Idetificatio ad Qualificatio Study Specific Traiig with Competecy Assessmets Medical Writig Settig Up ad Maagig the DSMB Study Rescue ad Clea Up, icludig Cost Savig Aalysis Please cotact us at or visit our website at

8 CRA Fellowship Program Compoets Educatio ad traiig Strict selectio criteria Competecy testig Metorig Accoutability Ogoig performace evaluatios Assessed for the best fit for your compay. Cadidates are paired with a Traied Cliical Moitorig Metor CRA Solutios, Ic. also offers the CRA Fellowship Program TM, a cost-effective, quality approach to moitorig. Our Fellows are graduates of our 140-Hour Fudametals of Cliical Research Program ad are tested o core kowledge, moitorig competecy, ad kowledge of FDA GCP/ ICH GCP. To lear more or to receive a proposal, please cotact us at (877) or visit our website at CRA Fellowship Program The applicat is a graduate of the 140 Hour CRA Certificate Program that is part e-learig ad two weeks of hads o moitorig across two protocols. Graduates selected to apply for the fellowship are recommeded to have achieved a 80% passig score of the followig: Moitor Competecy Exam FDA GCP & ICH GCP Exam Applicats are pre-screeed usig behavioral iterviewig techiques ad a moitor report writig activity. This activity ca be customized to your orgaizatios processes. This aids i assessig the CRA s compatibility with your orgaizatio. The Fellows are paired with a MRM Cliical Moitorig Metor (CMM). The CMM has greater tha 4 years moitorig experiece ad has received Trai the Traier traiig. CMM ca accompay the Fellow o a traiigperformace evaluatio visit. This is a structured documeted visit that icludes assessmet tools, traiee istructioal guide, ad CMM leader's guide. This visit ca occur with your orgaizatio or may occur o a differet protocol. The CMM acts as a metor durig the two year fellowship; this icludes reviewig reports to assess ogoig quality ad reviewig moitorig tools for completio. To ehace kowledge, experiece, ad maitai cuttig edge moitorig strategies, the Fellows are required to research FDA Warig letters, summarizig their fidigs i quarterly GCP ICH roudtable discussios. They must preset strategies to correct ad prevet such deficiecies.