# ACDM: Empowering Excellence in Clinical Data Management

> Association for Clinical Data Management \(ACDM\) is a global membership association established in 1987\. Join a growing global community\.

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## Pages
- [ACDM India Summit 2026](https://acdmglobal.org/acdm-india-summit-2026/)
- [ACDM Hot Topic Committee](https://acdmglobal.org/acdm-hot-topic-committee/)
- [Respond to India Ballot Acceptance](https://acdmglobal.org/respond-to-india-ballot-acceptance/)
- [Hot Topic Recordings](https://acdmglobal.org/hot-topic-recordings/)
- [India Summit Sponsorship](https://acdmglobal.org/india-summit-sponsorship-expression-of-interest/)

## Layout Parts
- [become a member](https://acdmglobal.org/tbuilder-layout-part/become-a-member/)

## Global Styles
- [Rounded Image Gallery](https://acdmglobal.org/tglobal-style/tb_gs415e1/)
- [Image Shadow 1](https://acdmglobal.org/tglobal-style/tb_gs525d7/)

## Products
- [Preparing for Regulatory Inspections](https://acdmglobal.org/product/1685/): \<strong\>Preparing for Regulatory Inspections Course\.\</strong\>

This course provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome for your organisation\. You will understand what regulatory authorities are and what they do, and then learn how they conduct inspections and the key information they are looking for\.  The learning outcomes for the course are as follows:
\<ul\>
 	\<li\>Recap on the basics of ICH GCP focusing on the R2 addendum\</li\>
 	\<li\>Gain a knowledge of the cascade of regulations that exist\</li\>
 	\<li\>Understand the responsibilities of the regulatory authorities\</li\>
 	\<li\>Recognise the different types of inspection and what the inspectors inspect against\</li\>
 	\<li\>Understand the general inspection process\</li\>
 	\<li\>Understand what an inspection dossier and inspection plan is\</li\>
 	\<li\>Understand how to assure compliance to regulations\</li\>
 	\<li\>Recognise what you must do to prepare for an inspection\</li\>
 	\<li\>Know how to prepare your work area before the Inspector arrives\</li\>
 	\<li\>Understand how to interact with the Inspector\</li\>
 	\<li\>Recognise some of the typical Data Management findings from inspections\</li\>
\</ul\>
- [RECIST for Data Managers](https://acdmglobal.org/product/recist-for-data-managers/): \<strong\>RECIST for Data Mangers\</strong\>

This course provides data management professionals with the background and explanation of what RECIST is; and practical experience and recommendations for how the criteria are used in clinical trials along with tips to help aid RECIST data review\.

In the course you will learn
\<ol\>
 	\<li\>What RECIST is\</li\>
 	\<li\>The background of RECIST\</li\>
 	\<li\>The different methods of measurement\</li\>
 	\<li\>The types of lesions\</li\>
 	\<li\>Response criteria\</li\>
 	\<li\>Designing CRFs for RECIST data capture\</li\>
 	\<li\>Example validation checks for RECIST data review\</li\>
 	\<li\>CDISC Data Standards for RECIST\</li\>
 	\<li\>iRECIST\</li\>
 	\<li\>Efficacy endpoints in oncology\</li\>
\</ol\>
- [Fundamentals of Clinical Data Management](https://acdmglobal.org/product/online-training-fundamentals-of-clinical-data-management/): In today’s clinical trial environment with the increasing adoption of technology, roles are changing and a good understanding of clinical data management tasks is critical for the whole study team\. This course provides an overview of the fundamentals of clinical data management, explaining the key tasks data managers perform, highlighting the important interactions between study team members and how to ensure high quality clinical data\.

The course is suited to non\-data management professionals wanting to understand what clinical data management involves,  or data managers new to the role\.

By the end of this course you will:
\<ul\>
 	\<li\>Be able to describe the key clinical data management tasks in a clinical trial\</li\>
 	\<li\>Understand which tasks are important for ensuring high quality clinical data\</li\>
 	\<li\>Understand the critical interactions between clinical data management and other members of the study team\</li\>
\</ul\>
- [Understanding Laboratory Data](https://acdmglobal.org/product/online-training-understanding-laboratory-data/): For data managers laboratory data can prove to be frustrating, complex and time consuming\.

This course gives an explanation of what laboratory data consists of, why labs provide data in the way that they do, and gives practical advice to the data manager about how to handle this data and key points to consider\. The course is intended for a data manager with little or no previous experience with working with laboratory data\.

By the end of this course you will:
\<ul\>
 	\<li\>Understand the fundamentals of laboratory data\</li\>
 	\<li\>Recognise the different types of tests and how samples are prepared\</li\>
 	\<li\>Understand the use of different units and normal ranges\</li\>
 	\<li\>Realise why laboratories supply information in the way they do and where some of the challenges occur\</li\>
 	\<li\>Understand the difference between a central lab and a local lab and why they are used\</li\>
 	\<li\>Appreciate what should be considered during the set\-up of a trial when lab data is being collected\</li\>
 	\<li\>Understand different methods of collecting lab data for a trial\</li\>
 	\<li\>Specify what should be checked during the validation of lab data\</li\>
\</ul\>
 
- [Risk Based Monitoring](https://acdmglobal.org/product/online-training-risk-based-monitoring/): This course provides an overview of risk based monitoring\. In today’s clinical trial environment with the adoption of technology, traditional onsite monitoring with 100% SDV has been replaced by a leaner approach where the type and frequency of monitoring is driven by the risks associated with the trial\. This course explains how to take a risk based approach to monitoring\.

By the end of this course you will:
\<ul\>
 	\<li\>Understand the different types of monitoring; on\-site, remote and centralised\</li\>
 	\<li\>Learn what the regulations are when it comes to taking a risk based approach to monitoring\</li\>
 	\<li\>Know what to consider when performing a risk assessment\</li\>
 	\<li\>Recognise how to identify critical data and processes\</li\>
 	\<li\>Understand how centralised monitoring and data visualisation dashboards can be used\</li\>
 	\<li\>Recognise the benefits of risk based monitoring\</li\>
\</ul\>

## Courses
- [Medical coding](https://acdmglobal.org/courses/medical-coding/)
- [How Clinical Coding can ensure the success of clinical trials](https://acdmglobal.org/courses/how-clinical-coding-can-ensure-the-success-of-clinical-trials/)
- [Pharmacokinetics](https://acdmglobal.org/courses/data-validation-and-effective-query-writing-3/)
- [Data Validation \& Effective Query Writing](https://acdmglobal.org/courses/data-validation-and-effective-query-writing/)
- [Data Integrity](https://acdmglobal.org/courses/data-integrity/)

## Sections
- [How Clinical Coding can ensure the success of clinical trials](https://acdmglobal.org/lessons/how-clinical-coding-can-ensure-the-success-of-clinical-trials-2/)
- [Medical Coding](https://acdmglobal.org/lessons/agenda/)
- [Validating Data](https://acdmglobal.org/lessons/validating-data/)
- [Background](https://acdmglobal.org/lessons/background/)
- [What? How? Why?](https://acdmglobal.org/lessons/what-how-why/)

## Content
- [Guideline Refresher](https://acdmglobal.org/topic/guideline-refresher/)
- [Regulatory Authorities](https://acdmglobal.org/topic/regulatory-authorities/)
- [Before an Inspection](https://acdmglobal.org/topic/preparing-for-an-inspection/)
- [Inspection Conduct](https://acdmglobal.org/topic/inspection-conduct/)
- [RECIST Terminology](https://acdmglobal.org/topic/recist-terminology/)

## Tests
- [Medical Coding](https://acdmglobal.org/quizzes/medical-coding/)
- [How Clinical Coding can ensure the success of clinical trials](https://acdmglobal.org/quizzes/how-clinical-coding-can-ensure-the-success-of-clinical-trials/)
- [Sponsor oversight](https://acdmglobal.org/quizzes/sponsor-oversight/)
- [Pharmacokinetics](https://acdmglobal.org/quizzes/pharmacokinetics/)
- [Data Validation \& Effective Query Writing](https://acdmglobal.org/quizzes/data-validation-effective-query-writing/)

## Certificates
- [c2](https://acdmglobal.org/certificates/c2/)
- [certificate 1](https://acdmglobal.org/certificates/certificate-1/)

## Videos
- [ACDM Decentralised Clinical Trials Symposia Highlights](https://acdmglobal.org/video/acdm-decentralised-clinical-trials-symposia-highlights/)
- [ACDM Decentralised Clinical Trials Symposia  \- Message from Sagar Kurhekar](https://acdmglobal.org/video/acdm-decentralised-clinical-trials-symposia-message-from-sagar-kurhekar/)
- [ACDM Decentralised Clinical Trials Symposia  \- Message from Florentin Ory](https://acdmglobal.org/video/acdm-decentralised-clinical-trials-symposia-message-from-florentin-try/)
- [ACDM Decentralised Clinical Trials Symposia  \- Message from John Hall](https://acdmglobal.org/video/acdm-decentralised-clinical-trials-symposia-message-from-john-hall/)
- [ACDM Decentralised Clinical Trials Symposia  \- Message from Richard Davies](https://acdmglobal.org/video/acdm-decentralised-clinical-trials-symposia-message-from-richard-davies/)

## Categories
- [Membership](https://acdmglobal.org/category/membership/)
- [Uncategorized](https://acdmglobal.org/category/uncategorized/)

## Product categories
- [Online Training](https://acdmglobal.org/product-category/online-training/)
- [Memberships](https://acdmglobal.org/product-category/memberships/)

## Video Categories
- [ACDM23](https://acdmglobal.org/video-category/acdm-conference-2023/)
- [ACDM Board](https://acdmglobal.org/video-category/acdm-board/)
- [DCT Symposia](https://acdmglobal.org/video-category/dct-symposia/)
- [AI Symposia](https://acdmglobal.org/video-category/ai-symposia/)

## Optional
- [Sitemap index](https://acdmglobal.org/sitemap_index.xml)