{"title":"Report Writing for CRAs","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseDescription.jpg?n=8101\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThis course is designed so that the participants walk away with usable skills and invaluable knowledge in clinical trial site visit report writing and review. The course combines lecture with real life scenarios, practicum exercises involving writing, editing and mapping of findings. Both beginners and those with experience will benefit from the content.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eLocate and become familiar with industry regulations and guidelines relating to report writing\u003c\/li\u003e\n\u003cli\u003eList the rules for writing an effective report\u003c\/li\u003e\n\u003cli\u003eIdentify the steps in effective report writing\u003c\/li\u003e\n\u003cli\u003eList the essential content of the four major types of monitoring visit reports\u003c\/li\u003e\n\u003cli\u003eDefine the report mapping process relating to action item identification, documentation \u0026amp; resolution monitoring\u003c\/li\u003e\n\u003cli\u003eIdentify the difference between efficient and inefficient report writing tools\u003c\/li\u003e\n\u003cli\u003eDemonstrate the ability to write a protocol deviation, onsite data query, action items, and more\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eClinical Research Monitors\u003c\/li\u003e\n\u003cli\u003eIn-house and field CRAs, CRCs transitioning to CRA role\u003c\/li\u003e\n\u003cli\u003eContract CRAs\u003c\/li\u003e\n\u003cli\u003eAnybody responsible for reviewing clinical reports including Project Managers, Quality Assurance Auditors, CRA Managers, Lead CRAs\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eNikki Christison, B.S., C.C.R.A.\u003c\/p\u003e\n\u003cp\u003eLily Romero, P.A., C.C.R.C.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?n=2216\"\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eReport Writing Roots and Mandates:\u003c\/b\u003e FDA requirements regarding monitoring, record and report keeping; ICH GCP E6 guidelines for monitoring visit reports and non-compliance\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003e10 Rules of Effective Report Writing:\u003c\/b\u003e Application of good report writing practices; steps in report writing: before, during, after\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eApproaches to Report Writing:\u003c\/b\u003e Objective vs. subjective, choice of tense \u0026amp; voice, use of abbreviations, fragments vs. full sentences, proper use of bullets, etc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eRemember Who Your Audience Is:\u003c\/b\u003e Who reviews and has access to monitoring reports\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eAlways Be Ready if Abducted by Aliens:\u003c\/b\u003e Designing reports to be independent of author to smoothly handle staffing changes and\/or temporary stand-ins\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eThe Mapping and Flow of Reports:\u003c\/b\u003e Each report depends on one another; reports and follow-up letters correlation; contact reports; mapping to action item resolution\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eThe Major Types of Monitoring Reports:\u003c\/b\u003e Evaluation, initiation, interim, closeout, combos and abbreviated\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eUse of References to Support Report Claims:\u003c\/b\u003e Documentation of protocol sections and past correspondence, etc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eAnswering the Question Right and Answering the Right Question:\u003c\/b\u003e Comment when needed; make it mean something; document teaching and re-instruction; document what was accomplished and what was not\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eCompliance Plans:\u003c\/b\u003e Development, agreement, and success!\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eIndustry Standards:\u003c\/b\u003e Best practice; goals and content of industry monitoring reports; regulatory authority use of report content\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eThe Mapping Process: Documenting and Critiquing\u003c\/li\u003e\n\u003cli\u003eWriting Critic: Review of “the Good, the Bad and the Ugly”— Documentation of findings, use of bullet points, documenting deviations from the protocol \u0026amp; other discrepancies, writing action items, writing on-site data queries, phone contact reports\u003c\/li\u003e\n\u003cli\u003eGroup Discussions of Best Practices\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-15-051-L01-P. Released: 8\/15.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/report-writing-for-cras.oembed","provider":"Barnett International ","version":"1.0","type":"link"}