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X-WR-CALDESC:Events for SOCRA
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DTSTART;VALUE=DATE:20261117
DTEND;VALUE=DATE:20261118
DTSTAMP:20260907T162004
CREATED:20260903T021748Z
LAST-MODIFIED:20260903T021748Z
UID:2198-1794873600-1794959999@socra.org
SUMMARY:FDA Clinical Trial Requirements Regulations\, Compliance and GCP Conference=
DESCRIPTION:FDA Clinical Trial Requirements Regulations\, Compliance and GCP LIVE Conference- Nov.17-18\nIncludes Multiple Live Events. The next is on 11/17/2026 at 8:30 AM (EST) \n\n\n\nAlready registered? Log in now.\n\n\n\n\n\n\nOverview\nSpeaker(s)\nContents (4)\n\n\n\nThis LIVE symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA\, NIH\, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations\, guidelines\, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The two (2) full-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply. \nPlease contact us with any questions or concerns at education@socra.org. \nPlease book your Hotel Room here: SOCRA FDA LIVE WORKSHOP ROOM RATE \nDates:\nTuesday November 17th and Wednesday November 18th\, 2026. \nTime:\n8:30 am EST to 4:00 pm EST \n*All times in Eastern Standard Time Zone \n Registration:\n\nStandard Rate – Member Fee – $600\nStandard Rate – Non-Member Fee *- $675\n\nContinuing Education Credit:\nSOCRA designates this educational activity for a maximum of 11.75 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 11.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. \nAccreditation Statements:\nCME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. \nCNE for Nurses: Society of Clinical Research Associates is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation. \nSOCRA Course Series: 700 \nPlease contact us with any \nquestions or concerns at education@socra.org.
URL:https://socra.org/event/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-2/
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20261202
DTEND;VALUE=DATE:20261203
DTSTAMP:20260907T162004
CREATED:20260331T235318Z
LAST-MODIFIED:20260903T021621Z
UID:231-1796169600-1796255999@socra.org
SUMMARY:CCRP Prep and GCP Review Course 
DESCRIPTION:Clinical Research Professional Certification Preparation and GCP Virtual Review Course – December 2&3\, 2026\n Includes Multiple Live Events. The next is on 12/02/2026 at 12:00 PM (EST) \n\n\n\nAlready registered? Log in now.\n\n\n\n\n\n\nOverview\nSpeaker(s)\nContents (4)\n\n\n\nGoal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. \nThis course will review the concepts identified in the CCRP Certification Examination Content Outline\, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice. \nMember Rate: $295.00 \nNon-Member Rate: $370.00 \nObjective: The goal will be accomplished through lecture\, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Please contact us with any questions or concerns at education@socra.org. \nLearning Objectives: Upon completion of the workshop\, the attendee should be able to: \n\nDiscuss the basic requirements necessary to meet the demands of a CRP in clinical practice\nDiscuss the basic components of compliance – Law\, regulation\, guidance\, policy and procedure\nExplain the drug/biologic development process\nDescribe the device development process\nOutline concepts for Good Clinical Practice (GCP)\nExplain the elements of informed consent\nDescribe the membership and reporting requirements of IRBs\nExplain rules relating to financial disclosure\nDiscuss the basics of study design\nExplain the rules and reporting requirements for adverse events and serious adverse events\nExplain study closure procedures and record retention guidelines\nOutline the reasons for monitoring\, audits and site visits\nExplain the Food and Drug Administration rules\, regulations\, and guidelines on research\nDiscuss the importance of investigational drug accountability\nDemonstrate and describe how to read clinical reports and records\nDiscuss Quality Assurance including\, Monitoring and Auditing\nExplain issues that would constitute clinical fraud\n\nThe purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination. \nPlease contact us with any questions or concerns at education@socra.org.
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-6/
LOCATION:Virtual 
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