Brookwood Global's 2023 Online Training Brochure

Brookwood Global’s on-demand online clinical research training courses

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Contents Introduction Our online training courses: NEW: The Clinical Trial Master File Essentials NEW: Essential Guide to the EU CTR Managing and Reporting Serious Breaches of the EU Clinical Trial Regulation CTR for ALL – a high-level overview of the EU CTR Clinical Investigator Site Awareness: the EU CTR Fundamentals of GCP

GCP for Clinical Data Management Are you ready for … a PV inspection? PV for ALL Essential PV – Know PV PV for the Local Safety Contact and L-QPPV PV Refresher Essential Safety Reporting for the Investigator Site Non-interventional Studies, General Principles (Module 1) NIS, Practical Aspects (Module 2) NIS Essentials for Investigators The Principles of the General Data Protection Regulation (GDPR) GCP for Clinical Laboratories Learn & Refresh UK Clinical Trial Regulations

Essential GCP for Sponsors GCP Refresher for Sponsors

Essential GCP for Investigators GCP Refresher for Investigators Are you ready for … a GCP inspection? Risk Management in Clinical Trials

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Brookwood has delivered training in clinical research and related areas for over 35 years, and is the preferred trainer to a large number of organizations. In addition to ‘face-to-face’ basic, advanced and update courses, Brookwood delivers a wide range of courses as webinars, virtual events and as online courses. All of our courses are kept up-to-date and can be customized to meet clients’ needs. We offer a fully managed service or clients can license and purchase the courses to run them on their own learning management systems. Our policy has always been to make our training interactive and relevant, engaging and activating participants as much as we can. Take a look at the exciting online courses in this brochure. Please do not hesitate to contact us should you require a bespoke course, either delivered face-to-face, as a webinar or as a customized online course on a topic not covered in this brochure.

Why buy our training courses? • Online, on-demand. Do it anywhere! All that is needed is a strong continuous internet signal • Globally log in at any time 24/7, 365 days a year • Can be done using PC, Mac, laptop, iPad, iPhone and android devices • Tracking of user activity • Progress reporting by user and group • Certification for satisfactory completion • The training is personalized using the participant’s first name • Costs depend on the number of participants • Excellent packages for multiple users • Option to fix costs with a 2-year agreement or longer • Help in the event of problems • Valuable e-resources.

Key:

Our ICH GCP E6(R2) Investigator Site Training meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. These courses have CPD awards from the Royal Colleges of Physicians of the United Kingdom and Hungarian versions have the accreditation of the Semmelweis University (SOTE), Budapest.

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All of our online training can be done on PCs, Macs, laptops, iPhones, iPads and android devices

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• ONLINE TRAINING •

GCP

The Clinical Trial Master File Essentials The Trial Master File (TMF) is one of the most common areas for critical and major inspection findings.

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This online course covers the key requirements of the TMF. It is suitable for all those involved with clinical trials who are generating and maintaining trial documents. The course takes around 1-hour to complete. The course is based on known inspection findings and the European Medicines Agency guideline on the Trial Master File. It has both read-only and narrated tracks. The course is packed with interactions to maintain interest and to enhance the learning experience. It is based on a series of questions that may be posed by an inspector or auditor and this forms the basis of a ‘health-check’ for those working with trial documents. Content includes: • Inspection metrics and critical TMF issues. • ICH basics relating to TMF. • Definition of the TMF and its content, the TMF index. • TMF and trial reconstruction.

• Documents common to several trials. • Segregation: sponsor, vendor and investigator documents. • Drafts and superseded documents. • Dealing with correspondence and emails. • Scanning and certified copies. • Destruction of trial documents. • Vendors and CRO involvement in the TMF. • Access and security. • Retention and archiving. • Quality management , QC, TMF oversight. • Impact of the pandemic on the TMF. • Filing rules and inspection readiness. Like our other online training courses, this course can be customized with client branding and logo. The course can be managed by Brookwood (registration, invitations, tracking, reporting and certification) or it can be provided as a Scorm file for delivery under licence using a client’s own LMS.

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• ONLINE TRAINING •

EU CTR

The EU Clinical Trial Regulation

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CTR for ALL – a high-level overview of the EU CTR

Implementation of the EU Clinical Trial Regulation 2014 No. 536 (the CTR) began on 31 January 2022. It is important that both sponsors and investigators are aware of the significant changes and new requirements. Our four new on-demand, online courses offer training • for those needing a high-level overview The courses are delivered using Brookwood’s Articulate Rise learning management platform. This allows participants to set their own

This 15-20 minute course is ideal for those needing a short, high-level introduction to the EU Clinical Trial Regulation (CTR). It covers the main changes to working practices and highlights some of the new important requirements. Content includes: • When the CTR applies. • What the CTR brings that’s new. • Heads up on the new trial authorization process. • Significant changes to trial conduct. • Modifications, notifications and reports. • How the CTR affects the Trial Master File.

password and access their training dashboard. For group participation, we are able to track activity and provide progress and completion reports to the training organizers. Alternatively, the course can be provided to organizations under licence as ‘Scorm files’ to be delivered on their own learning management system. All of our CTR courses come with a link to our unique online bookshelf which contains useful documents relating to the CTR. This bookshelf

• for those needing more in-depth knowledge • for investigator site members who need awareness of how the CTR changes their responsibilities and working practices. The courses are interactive, personalized using the participant’s name and have both narrated and read-only options. On completion of these courses, participants are able to print a certificate of completion for their training records.

is updated regularly and participants of courses have ongoing access to this.

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• ONLINE TRAINING •

EU CTR

EU CTR

EU CTR

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Managing and Reporting Serious Breaches of the EU CTR This 30-minute, on-demand course overviews the requirements of the CTR and the content of the European Medicines Agency guideline relating to the management and reporting of serious breaches of the Regulation, protocol and GCP. This training is suitable for all those involved in clinical trials in humans who may encounter a serious breach, including both sponsors and investigator site personnel, whether based in Europe or elsewhere. Content includes: • What is a reportable serious breach? • Definition of serious breaches: what the key words mean • Who should make a report and when • Examples of serious and non-serious breaches • Responsibilities of vendors and investigators.

Essential Guide to the EU CTR This 1-hour, on-demand course covers in more depth the main content and requirements of the EU CTR. Content includes: • Structure of the CTR and supporting guidelines • The Clinical Trial Information System (CTIS) • Interventional, non-interventional and low interventional trials • Authorization of a clinical trial • Notifications and templates • Substantial and non-substantial modifications • Site suitability statement • Informed consent requirements • Safety reporting • Serious breach reporting • Urgent safety measures • Summary of trial results • Trial Master File and document retention.

Clinical Investigator Site Awareness: the EU CTR This short 20-minute course provides

investigators and members of their team with a heads-up on what clinical trial staff need to know about the CTR. It highlights what is new and different, and what has changed from the previous EU requirements. Content includes: • Why the EU introduced the CTR • Scope of the CTR • New requirements relating to trial conduct • New consent requirements • Serious breaches and urgent safety measures • Changes to safety reporting requirements • Pre-trial information requirements • Retention of essential documents • Risk proportionate approaches to clinical trials • Changes for the sponsor.

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• ONLINE TRAINING •

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FLAGSHIP ONLINE COURSE

Fundamentals of GCP

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TransCelerate

Modern, exciting online, on-demand course covering the Good Clinical Practice (GCP) requirements of both sponsors and the investigator site.

• Based on ICH GCP Guidelines E6(R2). • Needs no prior knowledge of GCP. • Ideal as core basic training. • Suitable as a GCP refresher for sponsor and investigator site personnel. • A great course to provide GCP knowledge to those assisting with clinical trials, administrators, ethics committees and regulators. • Complete eight main sections to reach a final test. – GCP Essentials and Principles – Pre-study Activities – Protocol and Trial Conduct – Participant Protection and Safety – Data Quality and Reliability – Risk Management and Trial Monitoring

• Takes around 2 hours – stop and start at any time. • Interactions and quiz questions to maintain interest. • Personalised with first name. • Additional resources form part of the course including e-books entitled ‘Essential GCP’, ‘Indexed ICH GCP Guidelines’, ‘A Guide to Informed Consent’ and ‘Risk Management in Clinical Trials’. • Pass the final test (80% or more) to be awarded certification. • Opportunity to repeat incorrectly answered questions in the event of a test score lower than 80%. • Available as fully serviced training (registration, activity monitoring, progress reporting, certification, helpline) or run it on your own learning management system.

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– Documentation and Trial Files – Audit, Inspections and Closure • Narrated, or read-only.

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• ONLINE TRAINING •

GCP

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Click for product demo GCP Refresher for Sponsors 2 – inspection challenge • A fun way to learn and refresh GCP for all sponsor personnel needing GCP training. • Participants ‘meet’ five different GCP inspectors who each ask 10 questions on different topics. • Answer 8/10 questions correctly in order to progress to the next inspector meeting. • Once all inspectors have been visited, and enough questions answered correctly, the participant will be awarded certification. • In addition to the Q&As there are a number of ‘Did You Know?’ interactions to supplement knowledge. • Valuable e-books provided, including ‘A Guide to Informed Consent’, the ICH GCP E6(R2) guidelines and ‘Essential GCP’.

Essential GCP for Sponsors • New 2021 version • Essential Good Clinical Practice for Sponsors Online Training. • Based on the sponsor responsibilities laid down in Section 5 of the ICH GCP E6(R2) guidelines as well as some of the investigator responsibilities that sponsors need to monitor. • Users can choose between a narrated or read-only (no sound) track. • The training is divided into key sections, each with interactions. • Quick 50-question test at the end of the training confirms knowledge. • Those who attain the 80% pass mark will receive certification. • Test answers can be reviewed and the test retaken. • Takes around 1 hour.

GCP Refresher for Sponsors 1 – tallest buildings challenge • An interactive quiz game to scale the highest buildings of the world – it adds fun and interest to GCP training. • Sponsor-specific questions cover a wide range of GCP topics based on ICH E6(R2). • 11 levels of slightly increasing difficulty. • 5 questions at each level – must get 4 correct to proceed (80%). • Feedback given for incorrect answers, with opportunity to review and repeat the level. • Compulsory ‘Did You Know?’ sections to enhance learning. • Takes around 45 minutes.

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• ONLINE TRAINING •

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TransCelerate

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Essential GCP for Investigators • Online training available in 14 languages: English, French, German, Italian, Polish, LatAm Spanish, Brazilian Portuguese, Chinese, Japanese, Russian, Turkish, Serbian, Czech and Hungarian. • Based on the investigator responsibilities laid down in Section 4 of the ICH GCP E6(R2) guidelines. • Users can choose between a narrated or read-only (no sound) track. • The training is divided into key sections, each with interactions. • Integral quizzes and an online multi choice test at the end of the training confirm knowledge. • Those who attain the 80% pass mark receive certification. • Test answers can be reviewed and the test retaken. • Takes around 1 hour.

GCP Refresher for Investigators 2 – inspection challenge • A fun way to learn and refresh GCP for all investigator site personnel. • Participants ‘meet’ five different GCP inspectors who each ask 10 questions on different topics. • Answer 8/10 questions correctly in order to progress to the next inspector meeting. • Once all inspectors have been visited, the participant will be awarded certification. • In addition to the Q&As there are a number of ‘Did You Know?’ interactions to supplement knowledge. • Valuable resources provided, including ‘A Guide to Informed Consent’, the ICH GCP E6(R2) guidelines and ‘Essential GCP’. • Available in English and LatAm Spanish.

GCP Refresher for Investigators 1 – tallest buildings challenge • An interactive quiz game to scale the highest buildings of the world – it adds fun and interest to GCP training. • Investigator-specific questions cover a wide range of GCP topics based on ICH E6(R2). • 11 levels of slightly increasing difficulty – complete them all to pass. • 5 questions at each level – must get 4 correct to proceed (80%). • Feedback given for incorrect answers, with opportunity to review and repeat the level. • Compulsory ‘Did You Know?’ sections to enhance learning. • Takes around 45 minutes.

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• ONLINE TRAINING •

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Are you ready for … a GCP inspection? • Online, on-demand inspection readiness training. • Packed with information, ‘Words of Advice’ and practical tips. • Personalized, narrated or read-only options. • Takes around 35 mins. • Highly interactive. • Can be done on PCs, Macs, laptops and mobile devices 24/7/365. • Based on answers to a series of questions relating to inspections. • Developed with those experienced in inspections and those who perform them! • Comes with a downloadable self-checklist.

Risk Management in Clinical Trials In this 60-min course, we look at the general principles relating to risk management in clinical trials. We utilize relevant regulatory guidance as well as the principles in ICH GCP to help you to understand the risk management process and • The principles of risk-based management of clinical trials • Who should be involved in a risk assessment? •Why might risks change as the trial progresses? • Identification of ‘Critical to Quality Factors’ • The steps involved in a risk-based approach to clinical trials • Setting Quality Tolerance Levels • Risks at the system and trial level • Risk mitigation • Risk-based monitoring • Case studies • Quick quiz to test knowledge • Glossary of terms. This course can be customized to meet your processes and requirements. how this is done. Content includes:

GCP for Clinical Data Management

This online on-demand training with a quiz and certification is a fun interactive way for data management personnel to learn about their GCP responsibilities. Content includes: • Qualifications, training, SOPs • Computerized systems • Data flow and source data quality • Data collection, quality and management • Documentation • Using CROs • Risk register and risk-based approaches • GCP checklist for clinical data management.

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• ONLINE TRAINING •

PV

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Are you ready for … a PV inspection?

PV for ALL This 15 min* ‘Step 1’ online pharmacovigilance (PV) training is for an entire organization’s staff. It can be fully customized. Run it on your own server or let us manage it for you. Content includes: • Types of product safety information that may be encountered • Who might report safety information • How and when to report to the Local Safety Contact • Key information to be obtained.

Essential PV – Know PV This 60 min* ‘Step 2’ online training covers essential PV in more depth. It is ideal for those who need a more detailed knowledge of PV. Content includes: • What is and what governs PV • Roles and responsibilities • Key PV process steps; safety information and its capture • Product safety oversight • ADRs – basic facts, solicited v unsolicited reports • Expedited individual case safety reporting • MedDRA coding • Periodic safety reporting, PSURs, PBRERs, DSURs • Risk management planning • Safety signals • Reference safety information • PV system master file • Inspections.

This online, on-demand inspection readiness training takes around 35 minutes to complete. It is ideal for those facing a PV inspection, including the safety and clinical operations departments. Developed with Dr Lisbeth Tofte Hemmingsen, a well-respected PV and QA expert who has huge experience of inspections. • Based on answers to a series of questions relating to inspections. • Packed with information, ‘Words of Advice’ and practical tips. • Personalized, narrated or read-only options. • Highly interactive. • Can be done on PCs, Macs, laptops and mobile devices 24/7/365. • Comes with a downloadable self-checklist.

* Average time taken. Individual timings will vary.

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• ONLINE TRAINING •

PV

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PV for the Local Safety Contact and L-QPPV

PV Refresher An interactive Q&A game to update and refresh PV knowledge. Face five inspectors and answer 8/10 questions correctly each time to ‘pass the inspection’! Questions include a wide range of PV topics.

Essential Safety Reporting for the Investigator Site

This 40 min* ‘Step 3’ online training covers the responsibilities of the company’s Local Safety Contact and the additional obligations of a Local QPPV (L-QPPV). Suitable for those involved as Local Safety Contacts and those who work with them. Content includes: • Regulatory requirements and main responsibilities • L-QPPV’s role in capturing, recording and reporting local safety information and PV activities • Managing local challenges.

This course is essential for all investigators needing to have awareness of their safety reporting obligations arising from the treatment of patients in clinical research. • Covers the basic principles of safety reporting, key regulations, guidance and best practices that apply to clinical trials and observational/non-interventional studies. • Consists of presented material, ‘Did You Know?’ highlights to supplement knowledge and numerous interactions to make the learning more enjoyable. • Has great resources including ICH E2A e-book, ‘Essential Pharmacovigilance’ e-book, CIOMS form and CTCAE quick reference guide for causality assessment.

All of our online courses can be customized to meet your specific requirements. Let us run them for you using our full service package of registration, tracking, reporting and certification, or run them on your own learning management system.

* Average time taken. Individual timings will vary.

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• ONLINE TRAINING •

NIS

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Non-interventional Studies, General Principles (Module 1) Interactive, personalized, narrated and read only tracks, suitable for both inexperienced and experienced staff. Provides a generic core basic training (takes approx. 35 mins). Content includes: • What are non-interventional studies (NIS)? • Why perform NIS? • Definition of NIS • Declaration of Helsinki • Rules governing NIS • Data protection • Requests by regulators • PAS, PASS, PAES explained • NIS in pharmacovigilance • Pharmacovigilance inspections • Abbreviations explained • Glossary of terms • Short quiz.

NIS, Practical Aspects (Module 2) Designed around an air journey to different parts of the real world to learn about key elements of running NIS. Content includes: • Setting up and running NIS • Planning • Impact of EU and US requirements • Choosing a design • Role of SCOPE; GRACE principles • Cross-sectional, case-control and cohort studies • Protocol content and development • Declaration of Helsinki and NIS • ENCePP guidance • Study milestones • Consent in NIS • Study conduct • Analysis of data • Codes of conduct and agreements • Scientific independence • Monitoring • MAH oversight obligations • NIS and safety reports; risk management plans • Data privacy • Study report • Publication of results • Training • Documentation and archives • Glossary of terms • Short quiz.

NIS Essentials for Investigators This training provides an understanding of the general obligations of researchers when undertaking NIS. Topics include: • Definition of non-interventional • Types of study • Key factors affecting NIS • Ethics and consent • Health authority approval • Data privacy • Protocol and its content • Current medical practice • Safety data collection • Study contracts • Data access • Study reports • Publication of results • Glossary of terms and abbreviations • Short quiz.

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• ONLINE TRAINING •

GDPR

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The Principles of the General Data Protection Regulation (GDPR)

GCP for Clinical Laboratories – online training in GCLP This 30 min* narrated course is ideal for laboratory staff needing an insight into GCLP requirements, as well as sponsors’ monitors, medical experts and auditors who utilize laboratory services in clinical trials. It is based on the guidance given in the European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012. It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply. The program also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge.

Learn & Refresh UK Clinical Trial Regulations This 60 min* course is designed for those who need to learn about and demonstrate their UK Clinical Trial Regulations knowledge. • Can be used as either initial or refresher training. • Take a journey through the regions of the UK and visit famous landmarks whilst you answer questions on the UK Clinical Trial Regulations. • Several ‘Did You Know?’ interactions enhance knowledge. • Visit nine locations and answer 8/10 questions correctly in each section to move on. • If you finish your tour satisfactorily you will be awarded certification.

This 30 min* online on-demand training with a quiz and certification is an ideal way for those processing personal data to learn about the latest requirements for data protection. Content includes: • Key roles • Definitions of personal data • Applicability of the GDPR and exemptions • Consent and rights of Data Subjects • Legal basis for processing • Obligations towards Data Subjects • Risk assessment • Data transfer outside EEA • Record keeping • Data security and storage • The Data Protection Officer • Data protection ‘by design and default’ • Audits • Managing breaches, compensation and penalties • Data protection checklist • Specific content on the impact of GDPR on pharmacovigilance and clinical trials.

* Average time taken. Individual timings will vary.

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• ONLINE TRAINING •

Main website

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For our full range of online courses, publications and face-to-face training visit https:/ brookwood-global.com/Brochures/Online-Training

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