{"product_id":"case-report-form-design-strategy-and-standards-2026-08-24","title":"Case Report Form Design, Strategy, and Standards","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 \u003cp class=\"Abstract\"\u003eAccording to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): \"...no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study's outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.\"\u003c\/p\u003e \u003cp class=\"Abstract\"\u003eOther regulations, such as the ICH GCP E6 guidelines, identify the Case Report Form (CRF) as one of the essential documents for a clinical trial. Therefore, it is imperative to understand and implement the best practices of the CRF design process. That includes making sure all the protocol-required data are collected, ensuring the design of the CRF minimizes errors, and keeping the study coordinator in their normal workflow.\u003c\/p\u003e \u003cp class=\"Abstract\"\u003eIt is also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that data collection is consistent, concise, and compatible, hence, the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.\u003c\/p\u003e \u003cp class=\"Abstract\"\u003eThis workshop will discuss the principles of good CRF design, the timing of CRF design in relation to clinical trial start-up, and the team that will contribute to the data collection recommendations. Participants will review a sample protocol and determine which CRFs will be required to collect the appropriate data. We will discuss design philosophies and rationales and apply these principles in reviewing CRFs to critique design. We will also discuss the resources that are utilized in determining what data collection is required and the current standards for CRF data content.\u003c\/p\u003e \u003cp class=\"Abstract\"\u003eThe module based on best practices for CRF design as documented in the SCDM GCDMP will provide the understanding of the expectations for purposeful CRF design.\u003c\/p\u003e \u003cp class=\"Abstract\"\u003eNote: This workshop will deal with the principles and fundamentals relating to data elements for good CRF design. It is not intended as a training in a software application to create the CRF.\u003c\/p\u003e \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 \u003cul class=\"Abstract\"\u003e \u003cli\u003eIdentify data requirements\/CRFs based on protocol review\u003c\/li\u003e \u003cli\u003eEvaluate the rationale for consistency in data collection\u003c\/li\u003e \u003cli\u003eDiscuss CDASH standards for data collection in CRFs\u003c\/li\u003e \u003cli\u003eIdentify data compatibility issues and solutions to ensure appropriate data integration\u003c\/li\u003e \u003cli\u003eList the \"best practices\" for CRF design\u003c\/li\u003e \u003c\/ul\u003e \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 \u003cul class=\"Abstract\"\u003e \u003cli\u003eCase Report Form Designers\u003c\/li\u003e \u003cli\u003eClinical Data Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003c\/ul\u003e \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 \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 \u003cp class=\"Abstract\"\u003eDenise G. Redkar-Brown, MT\u003c\/p\u003e \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 \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 \u003cp\u003e\u003cb\u003e\u003ci\u003eDay 1: 9:00 a.m. - 4:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp class=\"Abstract\"\u003eCRF Definition, Purpose, Considerations\u003cbr\u003eBest Practices in CRF Design\u003cbr\u003eExternal Data Integration\u003cbr\u003eCDISC\/CDASH\u003c\/p\u003e \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 \u003cul class=\"Abstract\"\u003e \u003cli\u003eLearners should bring a case study to describe the CRF design process in their environment, and be prepared to discuss pitfalls or success stories based on their experiences\u003c\/li\u003e \u003cli\u003eReview GCP Guideline ICH GCP E6 and two sample CRFs (provided). Based on what they have read, learners will make the necessary amendments to the CRF to ensure compliance with these guidelines\u003c\/li\u003e \u003cli\u003eReview the sample protocol and schedule of events, and prepare a list of the CRFs which will be required for this study\u003c\/li\u003e \u003cli\u003eTake the Sample Standard CRF Specifications document and amend according to the sample protocol provided\u003c\/li\u003e \u003cli\u003eUtilize the sample protocol and schedule of events to \"design\" Efficacy CRFs required by the protocol (Spirometry Testing, ABECB Symptom Assessment, or Evaluation of Clinical Response), and then add this form to the CRF Specification that was completed in the previous exercise\u003c\/li\u003e \u003cli\u003eStudents will review CDASH document and prepare a rationale document that they can use to \"influence\" management on the benefits using CDASH initiative\u003c\/li\u003e \u003c\/ul\u003e \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 \u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day 1\/2 hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e \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 \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 \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 \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 6 hours (0.6 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# 0778-0000-13-014-L01-P. Released 3\/13.\u003c\/p\u003e \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 \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","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375389598061,"sku":"BI17378","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/case-report-form-design-strategy-and-standards-2026-08-24","provider":"Barnett International ","version":"1.0","type":"link"}