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About Course Understand the Ethical and Regulatory Framework for Conducting Clinical Trials Course Description This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring you grasp the essential standards for conducting clinical research. Course Objectives By the end of this course, you will be able to: Articulate the definition, purpose, and historical context of GCP. Explain the importance of GCP in protecting human subjects and ensuring data integrity. Identify key international organizations involved in establishing GCP standards. Apply ethical principles and informed consent procedures in clinical research. Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice. Design and conduct clinical trials according to ICH E8 and E9 guidelines. Manage and report clinical trial data in compliance with ICH E6(R2) guidelines. Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines. Navigate regulatory compliance and inspections related to clinical trials. Target Audience This course is designed for individuals who: Are interested in pursuing a career in clinical research or clinical trial management. Work in the pharmaceutical, biotechnology, or medical device industry. Seek to gain a comprehensive understanding of GCP principles and practices. Prerequisites No prior experience in clinical research is required. However, a basic understanding of research methodology and medical terminology is recommended. Please Note: This course is strictly theoretical and does not qualify participants for clinical practice in the industry. Additional training and certifications may be required for hands-on experience. What Will You Learn? Articulate the definition, purpose, and historical context of GCP. Explain the importance of GCP in protecting human subjects and ensuring data integrity. Identify key international organizations involved in establishing GCP standards. Apply ethical principles and informed consent procedures in clinical research. Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice. Design and conduct clinical trials according to ICH E8 and E9 guidelines. Manage and report clinical trial data in compliance with ICH E6(R2) guidelines. Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines. Navigate regulatory compliance and inspections related to clinical trials. Course Content Introduction to Good Clinical Practice (GCP) and ICH Guidelines Introduction to Good Clinical Practice (GCP) and ICH Guidelines Ethical Principles, Informed Consent, and ICH E6(R2) Ethical Principles, Informed Consent, and ICH E6(R2) Designing and Conducting Clinical Trials with ICH E8 and E9 Designing and Conducting Clinical Trials with ICH E8 and E9 Data Management and Reporting with ICH E6(R2) Data Management and Reporting with ICH E6(R2) Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3) Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3) Regulatory Compliance, Inspections, and ICH E6(R3) Regulatory Compliance, Inspections, and ICH E6(R3) A course by Xpert Learning RequirementsA basic understanding of research methodology and medical terminology is recommended. Audience Individuals who are interested in pursuing a career in clinical research or clinical trial management. Individuals who work in the pharmaceutical, biotechnology, or medical device industry. Individuals who seek to gain a comprehensive understanding of GCP principles and practices. Audience Individuals who are interested in pursuing a career in clinical research or clinical trial management. Individuals who work in the pharmaceutical, biotechnology, or medical device industry. Individuals who seek to gain a comprehensive understanding of GCP principles and practices.

When working in a care setting it is so important to build positive relationships with care users. Confidentiality and the correct handling of personal information are vital for trusting relationships and a breach in this may lead to a service user becoming unwilling to cooperate with their care providers. This course provides an introduction to the concept of handling information in care settings. At the end of the course you will understand the need for secure handling of information and you will know how to access support if you have any questions regarding access to information. The course will cover the important role confidentiality plays in developing trusting relationships with the people in your care and it will define key terms such as ‘need to know’ and ‘consent’. It also touches on the legislation that is in place relating to the handling and storing of information and the obligations each person has under these laws.

The Medication Administration and Preservation course provide essential knowledge and skills for the safe and appropriate handling of medicines in social care settings. Learners will be introduced to medication management legislation, risk assessment, consent to treatment, and proper recording procedures, ensuring they can administer and preserve medications effectively and responsibly. Learning Outcomes: Understand the legal and regulatory aspects of medication management in healthcare. Identify the principles and guidelines for the safe handling and administration of medicines. Perform risk assessments related to medication administration and manage potential risks. Learn the procedures for handling medication in social care settings, ensuring patient safety. Familiarize with the six rights of medication administration to prevent errors. Recognize the importance of obtaining consent for medication treatment. Comprehend the storage, transfer, and disposal guidelines for various medications. Understand drug formulations and different methods of administering medications. Why buy this Medication Administration and Preservation? Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Medication Administration and Preservation you will be able to take the MCQ test that will assess your knowledge. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this course for? Healthcare professionals working in social care settings. Caregivers and support staff responsible for medication administration. Medical students or trainees seeking comprehensive knowledge of medication handling. Individuals pursuing a career in the healthcare sector with an interest in medication management. Prerequisites This Medication Administration and Preservation was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path Medication Administrator: Responsible for administering medications in healthcare facilities. Care Assistant: Assist patients with their daily living activities, including medication management. Social Care Worker: Provide support and assistance to individuals in social care settings. Healthcare Coordinator: Oversee medication administration and related protocols. Pharmacy Technician: Assist pharmacists in dispensing and managing medications. Course Curriculum Module 01: Introduction to Safe Handling of Medicines Introduction to Safe Handling of Medicines 00:23:00 Module 02: Legislation and guidance of medication management Legislation and guidance of medication management 00:17:00 Module 03: Principles of Safe and Appropriate Handling of Medicines Principles of Safe and Appropriate Handling of Medicines 00:30:00 Module 04: Medication Risk Assessment Guidance Medication Risk Assessment Guidance 00:20:00 Module 05: Handling Medicines in Social Care Settings Handling Medicines in Social Care Settings 00:56:00 Module 06: Consent to Treatment Consent to Treatment 00:27:00 Module 07: Requirements for Specific Services Requirements for Specific Services 00:41:00 Module 08: Levels of Care and Support Levels of Care and Support 00:10:00 Module 09: Procedure for Handling Medication Procedure for Handling Medication 00:15:00 Module 10: The Six Rights of Medication Administration The Six Rights of Medication Administration 00:19:00 Module 11: Covert Administration of Medication Covert Administration of Medication 00:18:00 Module 12: Recording Procedures Recording Procedures 00:17:00 Module 13: Storage of Medication Storage of Medication 00:11:00 Module 14: Transfer and Disposal of Medication Transfer and Disposal of Medication 00:14:00 Module 15: Drug Formulation and Ways of Taking It Drug Formulation and Ways of Taking It 00:56:00

This one day course will support teachers and RSE leads in special colleges and special schools with post 16 learners to deliver a meaningful curriculum through the Preparing for Adulthood outcomes. The course will explore key issues for older learners, including how to teach about practical aspects of relationships such as attraction and fancying people, starting relationships, negotiation and consent discussions, and how to keep yourself safe. Participants will leave with increased confidence to develop and deliver a skills-based, rights focused curriculum that will empower learners to be able to navigate their personal lives and relationships with autonomy.   Aim: To develop confidence to create and deliver an age-appropriate, rights based RSE curriculum for young adults with learning disabilities.   Outcomes: Participants will develop understanding of requirements for RSE for older learners, including the statutory guidance and preparation for adulthood outcomes, and how RSE can support independent living consider specific challenges young people with SEND may face in developing relationships and explore practical and creative ways to support relationship skill development explore strategies to address sexualised behaviour, and what to do if a learner begins or wants to masturbate in college   Who is this course for? This one day course is ideal for teachers and RSE leads working in special schools and tutors in colleges with older learners, up to age 25, and beyond.

Unlock the essentials of healthcare data protection with our comprehensive course, 'Healthcare GDPR: Understanding Patient Data.' Delve into GDPR obligations, data governance, and safeguarding health data in the modern age. Ideal for healthcare professionals navigating the intricate landscape of patient data, this course empowers you with the knowledge to ensure compliance and ethical handling in the dynamic world of healthcare. Enroll now to become a guardian of patient privacy and data security.

What do we mean by Person Centred Care, well the term originated in the 1940s and proposed taking a holistic view of service users in care settings. This means getting to know the person and then tailoring their care as much as possible to meet their specific needs. Person centred care is now a key principle outlined in current legislation and it plays an important part in the standards that they set out which must be followed by all care professionals working in this country. This course will give you an understanding of person centred approaches for care and support, and how to implement a person-centred approach in an adult social care setting. It starts by explaining what we mean by person centred care and where this term originated. It then goes on to analyse the values represented by person centred care and explains why care should be as much as possible tailored to each service user. Finally it will give you an overview of care plans, daily reports, the importance of obtaining consent and much more.

This short online programme is designed for anyone who comes into contact with children through their work or leisure activities. Information sharing is key to delivering better, more efficient services that are coordinated around the needs of children, young people and families. It is essential to enable early intervention and preventative work, for safeguarding and promoting welfare and for wider public protection. Information sharing is a vital element in improving outcomes for all.

A one day course on GDPR for beginners, including practical exercises.

Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 17 Points Development Level Develop