Name: CT03f - Informed consent in clinical trials
Price: 25 GBP
Availability: InStock

<p>In the intricate world of healthcare, clinical research is a beacon, shining light on innovations and advancements. Dive into '<strong>Clinical Research Administration: Navigating the Healthcare Landscape</strong>', an expertly curated journey that marries in-depth knowledge with actionable strategies. This course will guide you from the foundations of clinical research to its evolving future. You'll traverse trial designs, the imperatives of ethics, data intricacies, and quality controls, ensuring you're equipped to lead, innovate, and make pivotal decisions within the clinical research realm.</p>
<p><strong>Learning Outcomes</strong></p>
<ul>
<li>Gain a robust understanding of the clinical research ecosystem and its administration.</li>
<li>Design and plan effective clinical trials while ensuring ethical and regulatory compliance.</li>
<li>Master the art of data management, ensuring accuracy and reliability.</li>
<li>Oversee trial monitoring, auditing, and meticulous safety reporting.</li>
<li>Analyse clinical data proficiently and forecast the future trends in clinical research.</li>
</ul>
<h3><b>Why choose this <span>Clinical Research Administration: Navigating the Healthcare Landscape</span><span> course</span>?</b></h3>
<ul>
<li>Unlimited access to the course for a lifetime.</li>
<li>Opportunity to earn a certificate accredited by the <b>CPD Quality Standards</b><b> </b>after completing this course.</li>
<li>Structured lesson planning in line with industry standards.</li>
<li>Immerse yourself in innovative and captivating course materials and activities.</li>
<li>Assessments are designed to evaluate advanced cognitive abilities and skill proficiency.</li>
<li>Flexibility to complete the <b>Clinical Research Associate: Administration &amp; Navigating the Healthcare Landscape</b> Course at your own pace, on your own schedule.</li>
<li>Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience.</li>
</ul>
<h3><b>Who is this <span>Clinical Research Administration: Navigating the Healthcare Landscape</span><span> </span></b><b><span>course </span></b><b>for?</b></h3>
<ul>
<li>Aspiring clinical researchers poised to shape the future of healthcare.</li>
<li>Healthcare administrators seeking specialised knowledge in research.</li>
<li>Medical students aiming to bolster their understanding of clinical trials.</li>
<li>Ethics committee members desiring a broader perspective.</li>
<li>Quality assurance professionals in the healthcare sector.</li>
</ul>
<h3><b>Career path</b></h3>
<ul>
<li><strong>Clinical Research Coordinator</strong>: £25,000 - £40,000</li>
<li><strong>Clinical Data Manager</strong>: £35,000 - £60,000</li>
<li><strong>Clinical Research Associate</strong>: £30,000 - £50,000</li>
<li><strong>Regulatory Affairs Specialist</strong>: £40,000 - £70,000</li>
<li><strong>Clinical Trials Auditor</strong>: £40,000 - £65,000</li>
<li><strong>Clinical Research Manager</strong>: £50,000 - £80,000</li>
</ul>
<h3><b>Prerequisites</b></h3>
<p><span>This </span><b>Clinical Research Associate: Administration &amp; Navigating the Healthcare Landscape</b><span> does not require you to have any prior qualifications or experience. You can just enrol and start learning.This </span><b>Clinical Research Associate: Administration &amp; Navigating the Healthcare Landscape</b><span> 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.</span></p>
<h3><b>Certification</b></h3>
<p><span>After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8.</span></p><div>
				<h3>
	<span>Course Curriculum</span>
</h3>

<div>
<table width="100%">				<tbody><tr>
					<td colspan="4">Module 01: Introduction to Clinical Research Administration</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Introduction to Clinical Research Administration</td>
					<td> </td>
					<td><span><i></i> 00:15:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 02: Clinical Trial Design and Planning</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Ethics and Regulatory Compliance</td>
					<td> </td>
					<td><span><i></i> 00:11:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 03: Ethics and Regulatory Compliance</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Ethics and Regulatory Compliance</td>
					<td> </td>
					<td><span><i></i> 00:13:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 04: Institutional Review Boards (IRBs) and Ethics Committees</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Institutional Review Boards (IRBs) and Ethics Committees</td>
					<td> </td>
					<td><span><i></i> 00:10:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 05: Data Management and Recordkeeping</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Data Management and Recordkeeping</td>
					<td> </td>
					<td><span><i></i> 00:12:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 06: Safety Reporting and Adverse Events</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Safety Reporting and Adverse Events</td>
					<td> </td>
					<td><span><i></i> 00:10:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 07: Clinical Trial Monitoring and Auditing</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Clinical Trial Monitoring and Auditing</td>
					<td> </td>
					<td><span><i></i> 00:09:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 08: Study Site Management and Quality Control</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Study Site Management and Quality Control</td>
					<td> </td>
					<td><span><i></i> 00:17:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 09: Data Analysis and Reporting</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Data Analysis and Reporting</td>
					<td> </td>
					<td><span><i></i> 00:09:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 10: The Future of Clinical Research</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>The Future of Clinical Research</td>
					<td> </td>
					<td><span><i></i> 00:10:00</span></td>
				</tr>
				</tbody></table></div>

			</div>

Studyhub UK

Online Course Marketing

Clinical Governance

Clinical Research

Clinical Research Associate (CRA)

Medical Administration

Good Clinical Practice (GCP)

Clinical Research Associate: Administration & Navigating the Healthcare Landscape

General Admission

<p>Dive into the dynamic realm of clinical data analysis with our comprehensive <strong>Clinical Data Analysis with SAS</strong> course. This course is your passport to the pharmaceutical industry, guiding you through the essential components, phases of clinical trials, and types of data crucial in this field. You'll gain proficiency in interpreting clinical study documents, from protocols to ethical consent, enabling you to navigate the intricate world of clinical data. Our course equips you with SAS programming skills, empowering you to develop clinical study reports, analyze demographic data, and derive valuable insights. Whether you're a budding data analyst or a professional aiming to enhance your clinical data expertise, this course provides the knowledge and skills needed for a successful career in clinical data analysis.</p>
<p><strong>Learning Outcomes</strong></p>
<ul>
<li>Understand the key components and phases of the pharmaceutical industry.</li>
<li>Navigate clinical trials with insights into data types and reports.</li>
<li>Interpret clinical study documents, including protocols and ethical consent.</li>
<li>Develop clinical study reports using SAS programming.</li>
<li>Analyze demographic data and derive valuable insights.</li>
</ul>
<h3><b>Why choose this Clinical Data Analysis with SAS<span> course</span>?</b></h3>
<ol>
<li>Unlimited access to the course for a lifetime.</li>
<li>Opportunity to earn a certificate accredited by the <b>CPD Quality Standards</b> and <b>CIQ </b>after completing this course.</li>
<li>Structured lesson planning in line with industry standards.</li>
<li>Immerse yourself in innovative and captivating course materials and activities.</li>
<li>Assessments designed to evaluate advanced cognitive abilities and skill proficiency.</li>
<li>Flexibility to complete the Course at your own pace, on your own schedule.</li>
<li>Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience.</li>
<li>Unlock career resources for CV improvement, interview readiness, and job success.</li>
</ol>
<h3><b>Who is this Clinical Data Analysis with SAS<span> </span></b><b><span>course </span></b><b>for?</b></h3>
<ul>
<li>Aspiring clinical data analysts seeking to enter the pharmaceutical industry.</li>
<li>Professionals in healthcare, research, or data analysis looking to enhance their clinical data expertise.</li>
<li>Students and individuals interested in clinical data and its analysis.</li>
<li>Those who want to decode clinical study documents and reports.</li>
<li>Anyone aiming to unlock the world of clinical data analysis with SAS.</li>
</ul>
<h3><b>Career path</b></h3>
<ul>
<li><strong>Clinical Data Analyst</strong>: £25,000 - £50,000</li>
<li><strong>Biostatistician</strong>: £30,000 - £70,000</li>
<li><strong>Pharmaceutical Researcher</strong>: £25,000 - £60,000</li>
<li><strong>Data Scientist in Healthcare</strong>: £30,000 - £70,000</li>
<li><strong>Clinical SAS Programmer</strong>: £28,000 - £60,000</li>
<li><strong>Clinical Research Manager</strong>: £35,000 - £80,000</li>
</ul>
<h3><b>Prerequisites</b></h3>
<p><span>This </span><b>Clinical Data Analysis with SAS</b><span> does not require you to have any prior qualifications or experience. You can just enrol and start learning.This </span><b>Clinical Data Analysis with SAS</b><span> 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.</span></p>
<h3><b>Certification</b></h3>
<p><span>After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8.</span></p><div>
				<h3>
	<span>Course Curriculum</span>
</h3>

<div>
<table width="100%">				<tbody><tr>
					<td colspan="4">Course Promo</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Course Promo</td>
					<td> </td>
					<td><span><i></i> 00:01:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Section 01: Introduction</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>1.1 Components of the Pharma Industry</td>
					<td> </td>
					<td><span><i></i> 00:05:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>1.2 Phases of Clinical Trials</td>
					<td> </td>
					<td><span><i></i> 00:06:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>1.3 Data and Reports in Clinical Trials</td>
					<td> </td>
					<td><span><i></i> 00:04:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>1.4 Types of Data</td>
					<td> </td>
					<td><span><i></i> 00:05:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Section 02: Knowledge on Clinical Study Documents</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>2.1 Clinical Study Protocol</td>
					<td> </td>
					<td><span><i></i> 00:02:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>2.2 Ethical Consent</td>
					<td> </td>
					<td><span><i></i> 00:01:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>2.3 Inclusion-Exclusion Criteria</td>
					<td> </td>
					<td><span><i></i> 00:01:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>2.4 Statistical Analysis Plan: SAP, Mockshell and CRF</td>
					<td> </td>
					<td><span><i></i> 00:04:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Section 03: Developing the Clinical Study Reports</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.1 General SAS Programming Steps</td>
					<td> </td>
					<td><span><i></i> 00:02:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.2  One Search Report: Demographics Table</td>
					<td> </td>
					<td><span><i></i> 00:04:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.3 Understanding the Demographics Table</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.4 Programming the Demographics Table</td>
					<td> </td>
					<td><span><i></i> 00:05:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.5 Importing Raw Demographic Data into the SAS</td>
					<td> </td>
					<td><span><i></i> 00:04:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.6 Deciding what Procedure to Use</td>
					<td> </td>
					<td><span><i></i> 00:02:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.7 Deriving the AGE variable</td>
					<td> </td>
					<td><span><i></i> 00:10:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.8 Obtaining Summary Statistics for AGE</td>
					<td> </td>
					<td><span><i></i> 00:04:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.9 Adding the 3rd Treatment Group using Explicit Output</td>
					<td> </td>
					<td><span><i></i> 00:05:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.10 Deriving the SEX variable</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.11 Obtaining Summary Statistics for SEX</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.12 Concatenating the COUNT and PERCENT Variables</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.13 Deriving the RACE Variable</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.14 Obtaining Summary Statistics for RACE</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.15 Stacking All the 3 Summary Statistics Together</td>
					<td> </td>
					<td><span><i></i> 00:06:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.16 Fixing the Precision Points</td>
					<td> </td>
					<td><span><i></i> 00:04:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.17 Transposing Data</td>
					<td> </td>
					<td><span><i></i> 00:03:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.18 Fixing the Order of Statistical Parameters</td>
					<td> </td>
					<td><span><i></i> 00:05:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.19 Building the Final Report</td>
					<td> </td>
					<td><span><i></i> 00:02:00</span></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>3.20 Putting the Final Touches to the Report</td>
					<td> </td>
					<td><span><i></i> 00:11:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Resources</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Resources - Clinical Data Analysis with SAS</td>
					<td> </td>
					<td><span><i></i> 00:00:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Assignment</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Assignment -  Clinical Data Analysis with SAS</td>
					<td> </td>
					<td><span><i></i> 00:00:00</span></td>
				</tr>
				</tbody></table></div>

			</div>

Data Analyst

Ssas

Clinical Data Analysis with SAS

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">Product licence holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance, and they take risk minimisation action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">The methods used range from traditional medical assessment of individual spontaneous reports of adverse events, through &lsquo;data mining&rsquo; of large databases, observational studies of &lsquo;real world&rsquo; prescription and use, to interventional clinical trials.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.</p>

Zenosis

Good Manufacturing Practice (GMP)

Biotechnology

Healthcare IT

Pharmaceutical

Pharmacology

Drug Safety

Medical

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

PV04: Signal Detection and Management in Pharmacovigilance

<p>Take on a transformative journey into the dynamic realm of Clinical Research Administration. Ever felt the frustration of navigating the complex landscape of clinical trials? The intricacies of trial design, ethical considerations, and regulatory compliance can often be overwhelming. Fear not, as our comprehensive course offers a remedy to these challenges.</p><p>Picture yourself gaining mastery over the intricacies of data management, ensuring meticulous record-keeping that forms the backbone of successful clinical trials. Delve into the ethical core of research, understanding the nuances of compliance and the vital role of Institutional Review Boards. Experience the power of effective site management and quality control, fostering environments where trials thrive.</p><p>As the course unfolds, witness the evolution of clinical research, foreseeing the future trends that shape the landscape. Break free from the frustration of uncertainty, and step confidently into the world of Clinical Research Administration. Let this course be your guide, equipping you with the knowledge and skills to navigate, excel, and shape the future of clinical research. Your journey awaits - embrace the transformation.</p><p><strong>Key Features</strong></p><ul><li>CPD Accredited </li><li>FREE PDF + Hardcopy certificate</li><li>Fully online, interactive course </li><li>Self-paced learning and laptop, tablet and smartphone-friendly</li><li>24/7 Learning Assistance</li><li>Discounts on bulk purchases</li></ul><p><strong>Course Curriculum </strong></p><ul><li>Module 01: Introduction to Clinical Research Administration</li><li>Module 02: Clinical Trial Design and Planning</li><li>Module 03: Ethics and Regulatory Compliance</li><li>Module 04: Institutional Review Boards (IRBs) and Ethics Committees</li><li>Module 05: Data Management and Recordkeeping</li><li>Module 06: Safety Reporting and Adverse Events</li><li>Module 07: Clinical Trial Monitoring and Auditing</li><li>Module 08: Study Site Management and Quality Control</li><li>Module 09: Data Analysis and Reporting</li><li>Module 10: The Future of Clinical Research</li></ul><p><strong>Learning Outcomes:</strong></p><ul><li>Understand key principles in clinical trial planning and design.</li><li>Demonstrate proficiency in navigating ethical and regulatory frameworks.</li><li>Develop expertise in data management and rigorous recordkeeping.</li><li>Implement safety reporting protocols and manage adverse events effectively.</li><li>Conduct thorough clinical trial monitoring and auditing procedures.</li><li>Acquire skills in study site management, quality control, and data analysis.</li></ul><p><strong>Accreditation</strong></p><p>This course is <strong>CPD Quality Standards</strong> (<strong>CPD QS)</strong> accredited, providing you with up-to-date skills and knowledge and helping you to become more competent and effective in your chosen field.</p><p><strong>Certificate</strong></p><p>After completing this course, you will get a FREE Digital Certificate from Training Express.</p><h2>
        
        <div>CPD</div>
    </h2>

                        <div id="cpd">
                            <div>
                                <div>
                                    <div>
                                        10 CPD hours / points
                                    </div>
                                        <div>
                                            Accredited by CPD Quality Standards
                                        </div>
                                </div>
                            </div>
                        </div><h2>
        
        <div>Who is this course for?</div>
    </h2>

                        <div id="who_is_this_course_for">
                            <ul><li>Individuals aspiring to enter the field of clinical research.</li><li>Healthcare professionals seeking to broaden their skill set.</li><li>Graduates in life sciences or related disciplines.</li><li>Research assistants and coordinators aiming for career advancement.</li><li>Regulatory affairs professionals looking to specialise.</li><li>Quality assurance personnel in healthcare and pharmaceutical sectors.</li><li>Professionals transitioning to roles in clinical trial management.</li><li>Anyone keen on staying ahead in the evolving landscape of clinical research.</li></ul>
                        </div><h2>
        
        <div>Career path</div>
    </h2>

                        <div id="career_path">
                            <ul><li>Clinical Research Coordinator</li><li>Regulatory Affairs Specialist</li><li>Clinical Data Manager</li><li>Quality Assurance Auditor</li><li>Clinical Research Associate</li><li>Pharmacovigilance Officer</li></ul>
                        </div><h2>
        
        <div>Certificates</div>
    </h2>

                        <div id="optional_extras">
                                    <h4>Digital certificate</h4>
        <p>
            Digital certificate -
            Included
        </p>
            <div><p>Once you've successfully completed your course, you will immediately be sent a FREE digital certificate.</p></div>
        <h4>Hard copy certificate</h4>
        <p>
            Hard copy certificate -
            Included
        </p>
            <div><p>Also, you can have your FREE printed certificate delivered by post (shipping cost £3.99 in the UK).<br />For all international addresses outside of the United Kingdom, the delivery fee for a hardcopy certificate will be only <strong>£10</strong>.<br />Our certifications have no expiry dates, although we do recommend that you renew them every 12 months.</p></div>

                        </div>

Training Express

Clinical Research Administration Fundamentals Course

<div>
						<div>
							<div>
							<section>
						<div>
							<div>
					<div>
			<div>
							<div>
						<div>
				<div>
			<h2>Overview
</h2>		</div>
				</div>
				<div>
				<div>
								<div>
					<p><span>This comprehensive course on </span><b><span>Clinical Data Analysis with SAS</span></b> will deepen your understanding on this topic.</p><p><span><span>After successful completion of this course you can acquire the required skills in this sector. This </span><b>Clinical Data Analysis with SAS</b> comes with accredited certification, which will enhance your CV and make you worthy in the job market.</span></p><p><span><span>So enrol in this course today to fast track your career ladder.</span></span></p>					</div>
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			<h2>How will I get my certificate?</h2>		</div>
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					<p>You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate.<br /></p>					</div>
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			<h2>Who is This course for?</h2>		</div>
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					<p><span>There is no experience or previous qualifications required for enrolment on this </span><b><span>Clinical Data Analysis with SAS</span></b>. It is available to all students, of all academic backgrounds.</p>					</div>
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			<h2>Requirements</h2>		</div>
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					<p><span>Our </span><b><span>Clinical Data Analysis with SAS</span></b> is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible with tablets and smartphones so you can access your course on Wi-Fi, 3G or 4G.</p><p><span><span>There is no time limit for completing this course, it can be studied in your own time at your own pace.</span></span></p>					</div>
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			<h2>Career Path</h2>		</div>
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					<p><span>Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business &amp; Management, Admin, Accountancy &amp; Finance, Secretarial &amp; PA, Teaching &amp; Mentoring etc.</span></p>					</div>
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					</div> <h3>Course Curriculum</h3><div><p>5 sections • 30 lectures • 01:54:00 total length</p></div><div><div><div><div><div><div><div><p>•Course Promo: 00:01:00</p></div></div></div></div></div><div><div><div><div><div><div><p>•1.1 Components of the Pharma Industry: 00:05:00</p></div><div><div><p>•1.2 Phases of Clinical Trials: 00:06:00</p></div><div><div><p>•1.3 Data and Reports in Clinical Trials: 00:04:00</p></div><div><div><p>•1.4 Types of Data: 00:05:00</p></div></div></div></div></div><div><div><div><div><div><div><p>•2.1 Clinical Study Protocol: 00:02:00</p></div><div><div><p>•2.2 Ethical Consent: 00:01:00</p></div><div><div><p>•2.3 Inclusion-Exclusion Criteria: 00:01:00</p></div><div><div><p>•2.4 Statistical Analysis Plan: SAP, Mockshell and CRF: 00:04:00</p></div></div></div></div></div><div><div><div><div><div><div><p>•3.1 General SAS Programming Steps: 00:02:00</p></div><div><div><p>•3.2  One Search Report: Demographics Table: 00:04:00</p></div><div><div><p>•3.3 Understanding the Demographics Table: 00:03:00</p></div><div><div><p>•3.4 Programming the Demographics Table: 00:05:00</p></div><div><div><p>•3.5 Importing Raw Demographic Data into the SAS: 00:04:00</p></div><div><div><p>•3.6 Deciding what Procedure to Use: 00:02:00</p></div><div><div><p>•3.7 Deriving the AGE variable: 00:10:00</p></div><div><div><p>•3.8 Obtaining Summary Statistics for AGE: 00:04:00</p></div><div><div><p>•3.9 Adding the 3rd Treatment Group using Explicit Output: 00:05:00</p></div><div><div><p>•3.10 Deriving the SEX variable: 00:03:00</p></div><div><div><p>•3.11 Obtaining Summary Statistics for SEX: 00:03:00</p></div><div><div><p>•3.12 Concatenating the COUNT and PERCENT Variables: 00:03:00</p></div><div><div><p>•3.13 Deriving the RACE Variable: 00:03:00</p></div><div><div><p>•3.14 Obtaining Summary Statistics for RACE: 00:03:00</p></div><div><div><p>•3.15 Stacking All the 3 Summary Statistics Together: 00:06:00</p></div><div><div><p>•3.16 Fixing the Precision Points: 00:04:00</p></div><div><div><p>•3.17 Transposing Data: 00:03:00</p></div><div><div><p>•3.18 Fixing the Order of Statistical Parameters: 00:05:00</p></div><div><div><p>•3.19 Building the Final Report: 00:02:00</p></div><div><div><p>•3.20 Putting the Final Touches to the Report: 00:11:00</p></div></div></div></div></div><div><div><div><div><div><div><p>•Resources - Clinical Data Analysis with SAS: 00:00:00</p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>

Apex Learning

Data Analysis

Data Skills

<p>Enrolling in an <strong>Administration of Clinical Research</strong> course is essential in today's world, where clinical trials and medical advancements play a pivotal role in public health. The Administration of Clinical Research course curriculum covers comprehensive aspects of Clinical Research Administration, including clinical trial design, regulatory compliance, data management, and quality control. Learning Clinical Research Administration equips you with the skills to manage clinical trials effectively, ensuring that they are conducted ethically and efficiently. This knowledge is crucial for improving patient outcomes and advancing medical science.</p><p>In your professional career, expertise in Clinical Research Administration opens up numerous job opportunities, particularly in the UK, where the demand for skilled professionals in this field is growing. <strong>The average salary for Clinical Research Administrators in the UK ranges from £35,000 to £50,000 per year, reflecting the value of this specialization.</strong></p><p><strong>The sector of Clinical Research Administration is expanding, with a projected growth rate of around 6-8% annually,</strong> driven by the increasing need for innovative medical solutions and regulatory oversight. By mastering Clinical Research Administration, you enhance your employability and contribute to the advancement of medical research, making a significant impact on global health.</p><p><strong>Key Features:</strong></p><ul><li>CPD Certified Administration of Clinical Research Course</li><li>Free Certificate from Reed</li><li>CIQ Approved Administration of Clinical Research Course</li><li>Developed by Specialist</li><li>Lifetime Access</li></ul><p><strong>Course Curriculum</strong></p><ul><li><strong>Module 01:</strong> Introduction to Clinical Research Administration</li><li><strong>Module 02:</strong> Clinical Trial Design and Planning</li><li><strong>Module 03:</strong> Ethics and Regulatory Compliance</li><li><strong>Module 04:</strong> Institutional Review Boards (IRBs) and Ethics Committees</li><li><strong>Module 05:</strong> Data Management and Recordkeeping</li><li><strong>Module 06:</strong> Safety Reporting and Adverse Events</li><li><strong>Module 07:</strong> Clinical Trial Monitoring and Auditing</li><li><strong>Module 08:</strong> Study Site Management and Quality Control</li><li><strong>Module 09:</strong> Data Analysis and Reporting</li><li><strong>Module 10: </strong>The Future of Clinical Research</li></ul><p><strong>Learning Outcomes:</strong></p><ul><li>Master clinical trial design strategies for optimal planning.</li><li>Navigate ethical and regulatory frameworks with confidence and precision.</li><li>Implement robust data management systems for seamless recordkeeping.</li><li>Ensure safety reporting protocols meet industry standards and requirements.</li><li>Conduct thorough clinical trial monitoring and auditing processes effectively.</li><li>Utilise site management techniques to uphold quality control standards impeccably.</li></ul><h2>
        
        <div>CPD</div>
    </h2>

                        <div id="cpd">
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                                        10 CPD hours / points
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                                            Accredited by CPD Quality Standards
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                                        <h3>
                                            
                                                Administration of Clinical Research <span>1:59:16</span>
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                                                    <span>1: Module 1: Introduction to Clinical Research Administration</span>

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                                                    <span>2: Module 2: Clinical Trial Design and Planning</span>

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                                                    <span>3: Module 3: Ethics and Regulatory Compliance</span>

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                                                    <span>4: Module 4: Institutional Review Boards (IRBs) and Ethics Committees</span>

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                                                    <span>5: Module 5: Data Management and Recordkeeping</span>

                                                    <span>11:32</span>

                                                        
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                                                    <span>6: Module 6: Safety Reporting and Adverse Events</span>

                                                    <span>10:12</span>

                                                        
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                                                    <span>7: Module 7: Clinical Trial Monitoring and Auditing</span>

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                                                    <span>8: Module 8: Study Site Management and Quality Control</span>

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                                                    <span>9: Module 9: Data Analysis and Reporting</span>

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                                                    <span>10: Module 10: The Future of Clinical Research</span>

                                                    <span>10:21</span>

                                                        
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                                                    <span>11: CPD Certificate - Free</span>

                                                    <span>01:00</span>

                                                                                                                                                                
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                                                    <span>12: Leave A Review</span>

                                                    <span>01:00</span>

                                                                                                                                                                
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                                    </li><h2>
        
        <div>Who is this course for?</div>
    </h2>

                        <div id="who_is_this_course_for">
                            <p>This Administration of Clinical Research course is accessible to anyone eager to learn more about this topic. Through this course, you'll gain a solid understanding of Administration of Clinical Research. Moreover, this course is ideal for:</p><ul><li>Aspiring clinical research administrators seeking comprehensive knowledge.</li><li>Healthcare professionals transitioning into clinical research roles.</li><li>Individuals passionate about contributing to advancements in healthcare.</li><li>Researchers eager to enhance their understanding of trial administration.</li><li>Students pursuing careers in pharmaceuticals or healthcare management.</li></ul>
                        </div><h2>
        
        <div>Requirements</div>
    </h2>

                        <div id="requirements">
                            <p>There are no requirements needed to enrol into this Administration of Clinical Research course. We welcome individuals from all backgrounds and levels of experience to enrol into this Administration of Clinical Research course.</p>
                        </div><h2>
        
        <div>Career path</div>
    </h2>

                        <div id="career_path">
                            <p>After finishing this Administration of Clinical Research course you will have multiple job opportunities waiting for you. Some of the following Job sectors of Administration of Clinical Research are:</p><ul><li>Clinical Research Coordinator - £30K to £40K/year.</li><li>Data Manager - £35K to £45K/year.</li><li>Clinical Trial Auditor - £40K to £50K/year.</li><li>Regulatory Affairs Specialist - £45K to £55K/year.</li></ul>
                        </div><h2>
        
        <div>Certificates</div>
    </h2>

                        <div id="optional_extras">
                                    <h4>Digital certificate</h4>
        <p>
            Digital certificate -
            Included
        </p>
        <h4>Reed Courses Certificate of Completion</h4>
        <p>
            Digital certificate -
            Included
        </p>
            <div><p>Will be downloadable when all lectures have been completed.</p></div>

                        </div>

Online Training Academy

Administration of Clinical Research

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					<div><p>Gain the solid skills and knowledge to kickstart a successful career and learn from the experts with this step-by-step Clinical Data Management - Using SAS Programming training course. This Clinical Data Management - Using SAS Programming course for Consistent Profits has been specially designed to help learners gain a good command of Clinical Data Management - Using SAS Programming, providing them with a solid foundation of knowledge to understand relevant professionals' job roles.</p><p>Through this Clinical Data Management - Using SAS Programming course, you will gain a theoretical understanding of Clinical Data Management - Using SAS Programming and others relevant subjects that will increase your employability in this field, help you stand out from the competition, and boost your earning potential in no time.</p><p>Not only that, but this Clinical Data Management - Using SAS Programming training includes up-to-date knowledge and techniques that will ensure you have the most in-demand skills to rise to the top of the industry. </p><p>This course is fully CPD-accredited and broken down into several manageable modules, making it ideal for aspiring professionals.</p></div>
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										<span>Get help from our expert tutors anytime you need</span>
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										<span>You will receive a completion certificate upon completing the course.</span>
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										<span>Internationally recognized Accredited Qualification will boost up your resume.</span>
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										<span>You will learn the researched and proven approach adopted by successful people to transform their careers.</span>
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										<span>You will be able to incorporate various techniques successfully and understand your customers better.</span>
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										<span>Access to a computer or digital device with internet connectivity.</span>
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                            <div>
                                <h2>Course Curriculum</h2>
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<table width="100%">				<tbody><tr>
					<td colspan="4"><strong>Course Promo</strong></td>
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					<td>Course Promo</td><td><span>🕐 00:01:00</span></td>
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					<td colspan="4"><strong>Unit 01: Introduction</strong></td>
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					<td>1.1 Components of the Pharma Industry</td><td><span>🕐 00:05:00</span></td>
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					<td>1.2 Phases of Clinical Trials</td><td><span>🕐 00:06:00</span></td>
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					<td>1.3 Data and Reports in Clinical Trials</td><td><span>🕐 00:04:00</span></td>
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					<td>1.4 Types of Data</td><td><span>🕐 00:05:00</span></td>
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					<td colspan="4"><strong>Unit 02: Knowledge on Clinical Study Documents</strong></td>
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					<td>2.1 Clinical Study Protocol</td><td><span>🕐 00:02:00</span></td>
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					<td>2.2 Ethical Consent</td><td><span>🕐 00:01:00</span></td>
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					<td>2.3 Inclusion-Exclusion Criteria</td><td><span>🕐 00:01:00</span></td>
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					<td>2.4 Statistical Analysis Plan: SAP, Mockshell and CRF</td><td><span>🕐 00:04:00</span></td>
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					<td colspan="4"><strong>Unit 03: Developing the Clinical Study Reports</strong></td>
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					<td>3.1 General SAS Programming Steps</td><td><span>🕐 00:02:00</span></td>
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					<td>3.2  One Search Report: Demographics Table</td><td><span>🕐 00:04:00</span></td>
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					<td>3.3 Understanding the Demographics Table</td><td><span>🕐 00:03:00</span></td>
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					<td>3.4 Programming the Demographics Table</td><td><span>🕐 00:05:00</span></td>
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					<td>3.5 Importing Raw Demographic Data into the SAS</td><td><span>🕐 00:04:00</span></td>
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					<td>3.6 Deciding what Procedure to Use</td><td><span>🕐 00:02:00</span></td>
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					<td>3.7 Deriving the AGE variable</td><td><span>🕐 00:10:00</span></td>
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					<td>3.8 Obtaining Summary Statistics for AGE</td><td><span>🕐 00:04:00</span></td>
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					<td>3.9 Adding the 3rd Treatment Group using Explicit Output</td><td><span>🕐 00:05:00</span></td>
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					<td>3.10 Deriving the SEX variable</td><td><span>🕐 00:02:00</span></td>
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					<td>3.11 Obtaining Summary Statistics for SEX</td><td><span>🕐 00:03:00</span></td>
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					<td>3.12 Concatenating the COUNT and PERCENT Variables</td><td><span>🕐 00:03:00</span></td>
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					<td>3.13 Deriving the RACE Variable</td><td><span>🕐 00:03:00</span></td>
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					<td>3.14 Obtaining Summary Statistics for RACE</td><td><span>🕐 00:03:00</span></td>
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					<td>3.15 Stacking All the 3 Summary Statistics Together</td><td><span>🕐 00:06:00</span></td>
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					<td>3.16 Fixing the Precision Points</td><td><span>🕐 00:04:00</span></td>
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					<td>3.17 Transposing Data</td><td><span>🕐 00:03:00</span></td>
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					<td>3.18 Fixing the Order of Statistical Parameters</td><td><span>🕐 00:05:00</span></td>
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					<td>3.19 Building the Final Report</td><td><span>🕐 00:02:00</span></td>
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					<td>3.20 Putting the Final Touches to the Report</td><td><span>🕐 00:11:00</span></td>
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					<td>Resources - Clinical Data Analysis with SAS</td><td><span>🕐 00:00:00</span></td>
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Skill Up

Clinical Skills

Continuous Professional Development (CPD)

Gain the solid skills and knowledge to kickstart a successful career and learn from the experts with this

Clinical Data Management - Using SAS Programming

<h2>Description</h2><p><span><b>Parkinson's Disease Awareness Diploma</b> </span></p><p><span>Parkinson's disease, also known as PD, is a disorder that impacts the brain. This causes the individual to suffer from impaired movements, such as stiffness and shaking, that deteriorate with time. More specifically, PD is attributed to when an individual loses nerve cells within the brain's substantia nigra, resulting in reduced dopamine production. Dopamine is a neurotransmitter that is crucial in regulating movement in an individual. Several PD symptoms can be attributed to lowering this neurotransmitter's production. </span><br />
<span>It is indistinct as to what exactly causes Parkinson's disease. Scholars opine that blending genes and the environment increases the odds of falling prey to this condition. </span><br />
<span>An in-depth understanding of the condition and the issues tackled by PD are requisites for providing care. This Parkinson's Disease Awareness Diploma course will illuminate students on the hurdles individuals face with PD and equip them with the best practices to dispense while helping patients overcome those obstacles. </span><br />
<span>People experience Parkinson's Disease in various ways. Although there are many PD symptoms, not all patients will encounter them, and if they do, the symptoms will not automatically occur in the same magnitude and order. PD progresses in typical patterns, which scholars have broken down into stages. </span><br />
<span>PD is chronic and progressive. It influences the brain, which causes a plethora of movement impediments such as stiffness, shaking, and difficulty with balancing, coordination, and walking. Symptoms typically deteriorate as time advances. People may even experience issues with talking. </span><br />
<span>This Parkinson's Disease Awareness Diploma course outlines Parkinson's disease to enable students to understand the condition better. It equips them with the knowledge of its symptoms and ways to identify them. It elucidates the various stages of PD and the way the condition progresses. The course supplies an insight into the practices and approaches to be used while caring for patients ill with PD, both physical and emotional. </span><br />
<span>This informative Parkinson's Disease Awareness Diploma course analyses the causal factors behind the condition, its possible signs, and the process of diagnosing and treating it. You will be acquainted with the impact of the disease on the patient's relationships and everyday life during its initial stages and how those difficulties progress as the condition advances later. </span><br />
<span>This Parkinson's Disease Awareness Diploma course examines and elucidates the methods caregivers adopt while tackling deteriorating symptoms and enlists useful links to accessible resources. This Parkinson's Disease Awareness Diploma course is ideal for those looking to broaden their knowledge about Parkinson's disease and those caring for PD patients who are potential caregivers. Individuals working in the care sector, including but not limited to general practitioners, mental health specialists and healthcare staff, will equally benefit from this course. Additionally, carers working in care facilities and domiciliary situations, managers, family members, relatives and friends of patients will find this course incredibly insightful. </span></p><p><span><b>What you will learn </b> </span></p><p><span><b>1: </b>Parkinson's disease </span></p><p><span><b>2: </b>Symptoms and Diagnosis </span></p><p><span><b>3</b><strong>:</strong> After Diagnosis </span></p><p><span><b>4: </b>Treatment plan </span></p><p><span><b>5</b><strong>:</strong> Cam Therapies  and exercise </span></p><p><span><b>6: </b>Mental Health and Clinical Trials </span></p><p><span><b>7: </b>Maintaining Relationships and Career </span></p><p><span><b>8: </b>Advanced PD </span></p><p><span><b>9: </b>Caregiver and Financial Health </span></p><p><span><b>10: </b>Housing Options </span></p><h4>Course Outcomes</h4><p>
After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college.</p><h4>Assessment</h4><p>
Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter.</p><h4>Accreditation</h4><p>
Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.</p>

Elearncollege

Parkinson's Disease Awareness Course

Cambridge

Research Quality Association

Implementing Good Clinical Laboratory Practice

RQA Member

Non Member

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.</p>

Healthcare

Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.

CT03f - Informed consent in clinical trials

<p id="isPasted" fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;">If you are involved with medical research or clinical trials you will need to handle large amounts of very sensitive personal data, and, of course, clinical trials are heavily regulated. &nbsp;The international<span style="color: rgb(16, 24, 64); box-sizing: border-box;" id="isPasted" fr-original-style="color: rgb(16, 24, 64);">&nbsp;nature of this sort of activity</span> gives rise to serious data protection issues.</p><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;">The course focuses principally on the requirements of both the EU GDPR and the UK GDPR and the exemptions permitted by them.&nbsp; It also considers requirements arising from the Clinical Trials Regulation.</p><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;">Topics covered will include:</p><ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">brief overview of data protection principles and legal bases</li><li fr-original-style="" style="box-sizing: border-box;">what is a suitable legal basis for processing personal data in clinical trials?<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Private vs public sector</li></ul></li><li fr-original-style="" style="box-sizing: border-box;">how does consent (and explicit consent) differ from &lsquo;informed consent&rsquo; (as required by the CTR)?<ul fr-original-style="" style="box-sizing: border-box;"><li fr-original-style="" style="box-sizing: border-box;">Confidentiality vs data protection</li></ul></li><li fr-original-style="" style="box-sizing: border-box;">record keeping for consent</li><li fr-original-style="" style="box-sizing: border-box;">privacy notice requirements for participants</li><li fr-original-style="" style="box-sizing: border-box;">data subject rights in context</li><li fr-original-style="" style="box-sizing: border-box;">processor (vendor) contracts and third party risk management</li><li fr-original-style="" style="box-sizing: border-box;">international transfers -&nbsp;the problem areas, legal solutions and potential technical solutions</li><li fr-original-style="" style="box-sizing: border-box;">CTR requirements</li><li fr-original-style="" style="box-sizing: border-box;">exemptions permitted by GDPR, specified in the Data Protection Act 2018 and similar legislation across the EU</li><li fr-original-style="" style="box-sizing: border-box;">the Data Protection Act 2018</li><li fr-original-style="" style="box-sizing: border-box;">Current developments in the UK and across the EU</li><li fr-original-style="" style="box-sizing: border-box;">Q&amp;A (normally dealt with throughout the course)</li></ul><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;">At Computer Law Training we have extensive experience of delivering data protection training at all levels and have worked with clinical trials companies, providing both training and compliance support. &nbsp;Some of the issues do not yet have definitive answers - the course will help you make data protection decisions and justify them.</p><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;">Course numbers are limited to 10 and the course is delivered on Zoom. &nbsp;Attendees will be expected to use a webcam. &nbsp;Together with Zoom&#39;s chat facility this will allow interaction with the trainer.</p>

If you are involved with medical research or clinical trials you will need to handle large amounts of very sensitive personal data, and, of course, clinical trials are heavily regulated. The international nature of this sort of activity gives rise to serious data protection issues.
The course focuses principally on the requirements of both the EU GDPR and the UK GDPR and the exemptions permitted by them. It also considers requirements arising from the Clinical Trials Regulation.
Topics covered will include:
brief overview of data protection principles and legal bases
what is a suitable legal basis for processing personal data in clinical trials?Private vs public sector
how does consent (and explicit consent) differ from ‘informed consent’ (as required by the CTR)?Confidentiality vs data protection
record keeping for consent
privacy notice requirements for participants
data subject rights in context
processor (vendor) contracts and third party risk management
international transfers - the problem areas, legal solutions and potential technical solutions
CTR requirements
exemptions permitted by GDPR, specified in the Data Protection Act 2018 and similar legislation across the EU
the Data Protection Act 2018
Current developments in the UK and across the EU
Q&A (normally dealt with throughout the course)
At Computer Law Training we have extensive experience of delivering data protection training at all levels and have worked with clinical trials companies, providing both training and compliance support. Some of the issues do not yet have definitive answers - the course will help you make data protection decisions and justify them.
Course numbers are limited to 10 and the course is delivered on Zoom. Attendees will be expected to use a webcam. Together with Zoom's chat facility this will allow interaction with the trainer.

Computer Law Training

Data Protection

GDPR

Data Privacy

Data Protection for Clinical Trials and Medical Research

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);"><span style="color: rgb(51, 51, 51); box-sizing: border-box;" id="isPasted" fr-original-style="color: rgb(51, 51, 51);">This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.</span></p>

This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

CT07: An Introduction to Clinical Trials and Drug Development

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">New drug development requires major investment in capital, human resources and technical expertise. Strict adherence to regulations on testing and manufacturing standards is also required before a new drug can be marketed. One of the greatest challenges in conducting clinical trials is that of efficiency. As trials become more comprehensive, involving large numbers of participants globally, their duration is prolonged and costs increase. The longer trials last, the shorter is the patent life remaining after market approval and the longer patients must wait for the new product. This short course covers the key components of clinical trials and how these requirements interact with the drug development cycle.</p>

New drug development requires major investment in capital, human resources and technical expertise. Strict adherence to regulations on testing and manufacturing standards is also required before a new drug can be marketed. One of the greatest challenges in conducting clinical trials is that of efficiency. As trials become more comprehensive, involving large numbers of participants globally, their duration is prolonged and costs increase. The longer trials last, the shorter is the patent life remaining after market approval and the longer patients must wait for the new product. This short course covers the key components of clinical trials and how these requirements interact with the drug development cycle.

CT04a - Clinical trials in drug development

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the European Economic Area (EEA). It establishes a harmonised procedure for gaining and maintaining authorisation for trials on the basis of a single electronic application per trial, and subsequent interactions, via a single EU online information system. Member states concerned in a trial (MSCs) collaborate on, and coordinate, its evaluation and supervision. The Regulation also mandates greater transparency of information on trials. The Regulation applies from 31 January 2022 and, after a grace period of one year, sponsors of all new clinical trials in the EEA must comply with it.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">This course describes the requirements that must be met by, and options available to, the sponsor during the conduct of an authorised clinical trial. It identifies the various interactions with MSCs that occur via the Clinical Trials Information System (CTIS), and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT11 sets out the European legal and regulatory context for clinical trials and describes how to apply via the CTIS for authorisation to conduct trials. The two courses therefore provide an ideal foundation for understanding and complying with the new law.</p>

This course describes the requirements that must be met by, and options available to, the sponsor during the conduct of an authorised clinical trial. It identifies the various interactions with MSCs that occur via the Clinical Trials Information System (CTIS), and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT11 sets out the European legal and regulatory context for clinical trials and describes how to apply via the CTIS for authorisation to conduct trials. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

CT12: How to Conduct Clinical Research Under the EU Clinical Trials Regulation

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">To conduct a clinical trial in one or more member states (MSs) of the European Economic Area (EEA) a sponsor must first gain the approval of each relevant national regulator and the favourable opinion of research ethics committees relevant to the investigational sites. The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the EEA. It establishes a harmonised procedure for gaining and maintaining authorisation for trials in up to 30 countries on the basis of a single electronic application per trial, and subsequent interactions, via a single EU online information system. MSs concerned in a trial collaborate on, and coordinate, its evaluation and supervision, and each MS returns a single decision on authorisation. The Regulation also mandates greater transparency of information on trials. The Regulation applies from 31 January 2022 and, after a grace period of one year, sponsors of all new clinical trials in the EEA must comply with it.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.</p>

This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);"><span style="color: rgb(51, 51, 51); box-sizing: border-box;" id="isPasted" fr-original-style="color: rgb(51, 51, 51);">This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.</span></p>

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

CT13: Safety Reporting in Clinical Trials

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">Analytical statistical elements are essential concepts in the design of clinical trials. This analysis helps us to understand whether a conclusion from a study of a sample of the target population applies generally to that population as a whole. In particular, it helps us to answer the question: Did the treatment effect in the given study occur just by chance? The statistical elements of a well-controlled study minimise the chances of drawing the wrong conclusions, by providing clear thresholds for such errors. The basic statistical elements of a clinical trial include eligibility criteria, randomisation, sample size, power, and blinding, and these are discussed in this short course.</p>

Analytical statistical elements are essential concepts in the design of clinical trials. This analysis helps us to understand whether a conclusion from a study of a sample of the target population applies generally to that population as a whole. In particular, it helps us to answer the question: Did the treatment effect in the given study occur just by chance? The statistical elements of a well-controlled study minimise the chances of drawing the wrong conclusions, by providing clear thresholds for such errors. The basic statistical elements of a clinical trial include eligibility criteria, randomisation, sample size, power, and blinding, and these are discussed in this short course.

CT04e - Statistical elements of clinical trials

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in &nbsp;each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">During the first year of transition to the Clinical Trials Regulation, sponsors have the option of applying for approval under the Directive, and they can continue trials under that regime until 31 January 2025.</p>

To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in  each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.

CT01: How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.</p>

Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

45 Courses delivered Online

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Clinical Data Management - Using SAS Programming

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Parkinson's Disease Awareness Course

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Implementing Good Clinical Laboratory Practice

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CT03f - Informed consent in clinical trials

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