SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
SDTM (Study Data Tabulation Model) defines a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting of human clinical trial data tabulations and for non-clinical study data tabulations which are to be submitted as part of a product application(IND and NDA) to a regulatory authority such as the United States Food and Drug Administration (FDA) and PMDA (Japan)
SDTM Training for personnel with Junior and Intermediate level Clinical Trial Experience. Covers summary of most domains. Salient features include order of domain creation, importance of making programming Data/Metadata Driven, Nature of Clinical Raw Data, Summary of the Clinical Trial process with regards to the data flow to arrive at the Study data to be submitted to regulatory authorities like FDA, Importance of deriving ADAM from SDTM and not directly from raw data, Information has been put together from variety of sources including my own programming work.
SDTM (Study Data Tabulation Model) defines a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting of human clinical trial data tabulations and for non-clinical study data tabulations which are to be submitted as part of a product application(IND and NDA) to a regulatory authority such as the United States Food and Drug Administration (FDA) and PMDA (Japan)
SDTM Training for personnel with Junior and Intermediate level Clinical Trial Experience. Covers summary of most domains. Salient features include order of domain creation, importance of making programming Data/Metadata Driven, Nature of Clinical Raw Data, Summary of the Clinical Trial process with regards to the data flow to arrive at the Study data to be submitted to regulatory authorities like FDA, Importance of deriving ADAM from SDTM and not directly from raw data, Information has been put together from variety of sources including my own programming work.
Shannon Labout has more than 17 years of experience in healthcare technologies, project management and clinical research. She is the past Senior Director of Education at CDISC, and has developed and delivered training on CDISC standards for audiences in North America, Europe and Asia since 2007. She has been involved in CDASH since the beginning of the project in 2006, co-led the CDASH team for the past 3-1/2 years, and has been a contributing member of the SDS team since 2007. She has participated in CRF standardization for the past fourteen years, and been involved in data standards development, harmonization and implementation at several CROs and global pharmaceutical companies. She has managed clinical data management teams in both the U.S. and Europe, and is currently the Director Data Management at Statistics & Data Corporation based in Tempe, Arizona.
Source: http://www.arena-international.com/ecdm/shannon-labout/3038.speaker
CDISC's CDASH and SDTM: Why You Need Both!Kit Howard
CDISC's clinical data standards are widely used for clinical research, but many people wonder why there seem to be two standards for collected data: the Clinical Data Acquisition Standards Harmonization (CDASH) standard and the Study Data Tabulation Model (SDTM) standard. This poster steps through four significant reasons that reflect the differences in philosophy, intermediate goals and broad-scale uses. Examples illustrate each reason and how they affect your studies.
A complex ADaM dataset - three different ways to create oneKevin Lee
The paper is intended for Clinical Trial SAS® programmers who create and validate a complex ADaM dataset. Some ADaM datasets require the use of complex algorithms. These algorithms could require several steps of data manipulation and more than one SDTM datasets. It can be very challenging to create a complex ADaM dataset in accordance with ADaM data structures and standards. Furthermore, it can be equally as challenging to validate those ADaM datasets. The paper will introduce three different ways to create a complex ADaM dataset. The first way is to create ADaM from SDTM directly without any intermediate permanent datasets. The second way is to create ADaM through the intermediate permanent datasets like SDTM+ or ADaM+ from SDTM. The third way is to create the final ADaM through the intermediate ADaM from SDTM. The paper will discuss the benefits and limitations of each method and also show some examples.
In this presentation, Principal Statistical Scientist Ben Vaughn explains how clinical trial data moves from collection in the case report form to its presentation to FDA.
Shannon Labout has more than 17 years of experience in healthcare technologies, project management and clinical research. She is the past Senior Director of Education at CDISC, and has developed and delivered training on CDISC standards for audiences in North America, Europe and Asia since 2007. She has been involved in CDASH since the beginning of the project in 2006, co-led the CDASH team for the past 3-1/2 years, and has been a contributing member of the SDS team since 2007. She has participated in CRF standardization for the past fourteen years, and been involved in data standards development, harmonization and implementation at several CROs and global pharmaceutical companies. She has managed clinical data management teams in both the U.S. and Europe, and is currently the Director Data Management at Statistics & Data Corporation based in Tempe, Arizona.
Source: http://www.arena-international.com/ecdm/shannon-labout/3038.speaker
CDISC's CDASH and SDTM: Why You Need Both!Kit Howard
CDISC's clinical data standards are widely used for clinical research, but many people wonder why there seem to be two standards for collected data: the Clinical Data Acquisition Standards Harmonization (CDASH) standard and the Study Data Tabulation Model (SDTM) standard. This poster steps through four significant reasons that reflect the differences in philosophy, intermediate goals and broad-scale uses. Examples illustrate each reason and how they affect your studies.
A complex ADaM dataset - three different ways to create oneKevin Lee
The paper is intended for Clinical Trial SAS® programmers who create and validate a complex ADaM dataset. Some ADaM datasets require the use of complex algorithms. These algorithms could require several steps of data manipulation and more than one SDTM datasets. It can be very challenging to create a complex ADaM dataset in accordance with ADaM data structures and standards. Furthermore, it can be equally as challenging to validate those ADaM datasets. The paper will introduce three different ways to create a complex ADaM dataset. The first way is to create ADaM from SDTM directly without any intermediate permanent datasets. The second way is to create ADaM through the intermediate permanent datasets like SDTM+ or ADaM+ from SDTM. The third way is to create the final ADaM through the intermediate ADaM from SDTM. The paper will discuss the benefits and limitations of each method and also show some examples.
In this presentation, Principal Statistical Scientist Ben Vaughn explains how clinical trial data moves from collection in the case report form to its presentation to FDA.
Implementation of CDISC ADAM in The Pharmacokinetics DepartmentSGS
SGS Life Science Services as a leading CRO, is one of the pioneers in the implementation of CDISC standards. Given the positive experiences in the SGS Data Management and Biostatistics Departments (implementation of SDTM and ADaM respectively), the Pharmacokinetics (PK) Department recently decided to adopt the CDISC standards as well.
In an SDTM database, pharmacokinetic data is stored as one record per subject, per time point (PC domain) or per pharmacokinetic parameter (PP domain). For the PK analysis, the generation of Tables, Listings and Figures, and the statistical analysis on PK parameters, ‘analysis ready’ datasets are created.
Audio and slides for this presentation are available on YouTube: http://youtu.be/6W_xoH4s-Yk
Dr. Patrick Wen, of Dana-Farber Cancer Institute's Center for Neuro-Oncology, discusses current clinical trial options for brain tumor patients and some of the new therapies available in neuro-oncology. This presentation was originally given at Dana-Farber Cancer Institute on Dec. 4, 2013.
Conduct title screening for systemic review- using Endnote Covidence – Pubric...Pubrica
Title screening process
Title screening overview
How do I screen?
Endnote overview:
Covidence overview:
Continue Reading: https://bit.ly/3AeFIYY
For our services: https://pubrica.com/services/research-services/systematic-review/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
Integrated Summary of Safety and Integrated Summary of EffectivenessSAYAN DAS
In my presentation, I discuss what both these summaries are, the potential challenges of creating these summaries, and how these summaries can be incorporated into the Common Technical Document (CTD).
For those interested in learning more about this vital topic, I invite you to check out my presentation for an in-depth, comprehensive analysis.
Pg. 05Question FiveAssignment #Deadline Day 22.docxmattjtoni51554
Pg. 05
Question Five
Assignment #
Deadline: Day 22/10/2017 @ 23:59
[Total Mark for this Assignment is 25]
System Analysis and Design
IT 243
College of Computing and Informatics
Question One
5 Marks
Learning Outcome(s):
Understand the need of Feasibility analysis in project approval and its types
What is feasibility analysis? List and briefly discuss three kinds of feasibility analysis.
Question Two
5 Marks
Learning Outcome(s):
Understand the various cost incurred in project development
How can you classify costs? Describe each cost classification and provide a typical example of each category.Question Three
5 Marks
Learning Outcome(s):
System Development Life Cycle methodologies (Waterfall & Prototyping)
There a several development methodologies for the System Development Life Cycle (SDLC). Among these are the Waterfall and System Prototyping models. Compare the two methodologies in details in terms of the following criteria.
Criteria
Waterfall
System Prototyping
Description
Requirements Clarity
System complexity
Project Time schedule
Question Four
5 Marks
Learning Outcome(s):
Understand JAD Session and its procedure
What is JAD session? Describe the five major steps in conducting JAD sessions.
Question Five
5 Marks
Learning Outcome(s):
Ability to distinguish between functional and non functional requirements
State what is meant by the functional and non-functional requirements. What are the primary types of nonfunctional requirements? Give two examples of each. What role do nonfunctional requirements play in the project overall?
# Marks
4 - PRELIMINARY DATA SCREENING
4.1 Introduction: Problems in Real Data
Real datasets often contain errors, inconsistencies in responses or measurements, outliers, and missing values. Researchers should conduct thorough preliminary data screening to identify and remedy potential problems with their data prior to running the data analyses that are of primary interest. Analyses based on a dataset that contains errors, or data that seriously violate assumptions that are required for the analysis, can yield misleading results.
Some of the potential problems with data are as follows: errors in data coding and data entry, inconsistent responses, missing values, extreme outliers, nonnormal distribution shapes, within-group sample sizes that are too small for the intended analysis, and nonlinear relations between quantitative variables. Problems with data should be identified and remedied (as adequately as possible) prior to analysis. A research report should include a summary of problems detected in the data and any remedies that were employed (such as deletion of outliers or data transformations) to address these problems.
4.2 Quality Control During Data Collection
There are many different possible methods of data collection. A psychologist may collect data on personality or attitudes by asking participants to answer questions on a questionnaire..
Test analysis: indentifying test conditionsJeri Handika
Test analysis is the process of looking at something that can be used to derive test information. This basis for the tests is called the 'test basis'. It could be a system requirement, a technical specification, the code itself (for structural testing), or a business process. (lets see.........)
Epoch provides training to students, professionals and corporate on SAS®, Data Management Activities and soft skills. Training includes Software Programming, Clinical, Analysis and Analytics modules, which can be availed by professionals with IT, Life Sciences, Medical, Statistics, MBA and such other backgrounds. Epoch is the pioneer in the courses designed of SAS designed for Clinical Programming world.
www.epoch.co.in, info@epoch.co.in
#bigdata
#hadoop
#sastraining
#epochsastraining
#sasonlinetraining
#clinicalprogramming
#epochsasonlinetraining
#epochresearchinstitute
Standards for clinical research data - steps to an information model (CRIM).Wolfgang Kuchinke
Standards for clinical research data: Introduction to CDISC standards CDASH, SHARE, PRM and BRIDG and their evaaluation to create a Information model for clinical research (CRIM). In particular, CRIM should allow the integrative usage of medical care data together with clinical research data; it should support the processes of the Learning Health System (LHS).
CDASH is Clinical Data Acquisition Standards Harmonization; it identifies the basic data collection fields needed from a clinical, scientific and regulatory perspective to enable more efficient data collection at the Investigator sites. SHARE is a globally accessible electronic library built on a common information model, which enables precise and standardized data element definitions that can be used in studies and applications to improve biomedical research. SHARE is intended to be a healthcare‐biomedical research enriched data dictionary. The Protocol Representation Model (PRM) focuses on the characteristics of a clinical study and the definitions and association of activities within the protocols and defines over 100 common protocol elements. The BRIDG Model is an instance of the Domain Analysis Model. The dynamic component of BRIDG defines the various processes and dynamic behaviour of the domain; the static component describes the concepts, attributes, and relationships of the static constructs which collectively define a domain-of-interest.
The CRIM was developed based on activity models and use cases. CRIM specifies the necessary information objects, their relationships and associated activities. It is required to fully support the development of TRANSFoRm project's tools for the Learning Health System. All activity objects of the workflows were defined and characterized according to their data requirements and information needs and mapped to the concepts of established information models including the above mentioned CDISC standards.
The best mapping results were achieved with PCROM and it was decided to use PCROM as basis for the development of CRIM. The comparison of PCROM with BRIDG found a significant overlap of concepts but also several areas important to research that were either not yet represented or represented quite differently in BRIDG. Adaption of PCROM to the needs of CRIM was acchieved by adding 14 information object types from BRIDG, two extensions of existing objects and the introduction of two new high-ranking concepts (CARE area and ENTRY area).
How to structure your table for systematic review and meta analysis – PubricaPubrica
According to the, a systematic review is "a scholarly method in which all empirical evidence that meets pre-specified eligibility requirements is gathered to address a particular research question."
Continue Reading: https://bit.ly/3AeFIYY
For our services: https://pubrica.com/services/research-services/systematic-review/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
• The PRISMA 2020 Statement was published in 2021.
• It consists of a checklist and a flow diagram, and is intended
to be accompanied by the PRISMA 2020 Explanation and
Elaboration document.
DMID Interventional Protocol TemplateVersion 2.028 April 2005DustiBuckner14
DMID Interventional Protocol Template Version 2.0
28 April 2005
Protocol Title Version number and date
GENERAL INSTRUCTIONS – delete this box from the submitted Protocol
This template is for students in the Virginia University of Lynchburg Doctor of Healthcare Administration Research Practicum course who are preparing a detailed protocol for a study involving human subjects. Depending on the nature of what you are doing, some sections may not be applicable to your research. If a section is not applicable, delete. You may delete subsections that are not applicable. The full research protocol must be uploaded to Moodle to be considered complete. This includes the IRB Application with research protocol, Informed Consent Document (s), Recruitment Collateral, and any other supporting documentation. Applications with ANY missing elements will be considered incomplete and will be graded accordingly.
Use this template to create a study protocol as follows:
· Red text represents instructions to you – to be deleted from the final version
· Blue text represents guidance on suggested content – to be edited and changed to black or replaced with black in the final version.
· Black text represents text that should ordinarily be incorporated as-is, if applicable
Note that the table of contents is automatically included, so do not change the content or formatting of the headings. Be sure to right click on the table of contents and select “Update field” before saving the protocol and uploading it to Moodle. As always, make sure to proofread the document before submission.
Please make sure to complete the header on this page with the protocol title and version number and date.
The submitted protocol should have no red or blue text (including the header and instruction boxes like this one). The submitted protocol should have no spelling or grammar errors. All references MUST be in APA 7 format. PROTOCOL TITLEProtocol Version Number: CompleteProtocol Version Date: day, month, year [Include if there is an external funder; otherwise, delete heading] Funding Mechanism: organization and grant or contract #[Include if there is industry support; otherwise, delete heading] Industry Support provided by: name of industryPrincipal Investigator: name Phone: Complete E-mail: Complete[Include if the study has a medical monitor; otherwise, delete heading] Medical Monitor: name
Table of Contents
1List of Abbreviations4
2Protocol Summary4
3Background/Rationale & Purpose5
3.1Background Information5
3.2Rationale and Purpose5
4Objectives5
4.1Study Objectives5
4.2Study Outcome Measures6
4.2.1Primary Outcome Measures6
4.2.2Secondary Outcome Measures6
5Study Design6
6Potential Risks and Benefits7
6.1Risks7
6.2Potential Benefits8
6.3Analysis of Risks in Relation to Benefits8
7Study Subject Selection8
7.1Subject Inclusion Criteria8
7.2Subject Exclusion Criteria8
7.3Recruitment Methods9
7.4Compensation for Participation in Research Activities9
7.5Withdrawal of Pa ...
Similar to SDTM (Study Data Tabulation Model) (20)
2. CDISC is a global, open, multidisciplinary, non-profit organization that has established
standards to support the acquisition, exchange, submission and archive of clinical
research data and metadata.
The CDISC mission is to develop and support global, platform-independent data
standards that enable information system interoperability to improve medical
research and related areas of healthcare. CDISC standards are vendor-neutral,
platform-independent and freely available via the CDISC website.
CDISC- Introduction
3. SDTM defines a standard structure for study data tabulations that are to be
submitted as part of a product application to a regulatory authority such as
the United States Food and Drug Administration (FDA)
Data tabulation datasets are one of four ways to represent the human subject
Case Report Tabulation (CRT)
SDTM provides a general framework for describing the organization of
information collected during human and animal studies and submitted to
regulatory authorities.
SDTM- Introduction
5. SDTM model is built around the concept of observations, which
consist of discrete pieces of information collected during a study.
Observations normally correspond to rows in a dataset. A collection
of observations on a particular topic is considered a domain.
Each observation can be described by a series of named variables.
Each variable, which normally corresponds to a column in a dataset,
can be classified according to its Role.
A Role describes the type of information conveyed by the variable
about each distinct observation and how it can be used.
Model Concept and Terms
6. • Identifier variables, such as those that identify the study, the
subject (individual human or animal or group of individuals)
involved in the study, the domain, and the sequence number of the
record.
• Topic variables, which specify the focus of the observation (such
as the name of a lab test).
• Timing variables, which describe the timing of an observation
(such as start date and end date).
• Qualifier variables, which include additional illustrative text, or
numeric values that describe the results or additional traits of the
observation (such as units or descriptive adjectives).
• Rule variables, which express an algorithm or executable method
to define start, end, or looping conditions in the Trial Design model.
Classification Of SDTM Variables
7. The set of Qualifier variables can be further categorized into five sub-classes:
• Grouping Qualifiers are used to group together a collection of observations within the
same domain. Examples include --CAT and --SCAT.
• Result Qualifiers describe the specific results associated with the topic variable in a
Findings dataset. They answer the question raised by the topic variable. Result Qualifiers
are --ORRES, --STRESC, and --STRESN.
• Synonym Qualifiers specify an alternative name for a particular variable in an
observation. Examples include --MODIFY and --DECOD, which are equivalent terms for a -
-TRT or --TERM Topic variable, and --TEST for --TESTCD.
• Record Qualifiers define additional attributes of the observation record as a whole
(rather than describing a particular variable within a record). Examples include --REASND,
AESLIFE, and all other SAE flag variables in the AE domain; AGE, SEX, and RACE in the DM
domain; and --BLFL, --POS, --LOC, --SPEC, and --NAM in a Findings domain
• Variable Qualifiers are used to further modify or describe a specific variable within an
observation and are only meaningful in the context of the variable they qualify. Examples
include --ORRESU, --ORNRHI, and --ORNRLO, all of which are Variable Qualifiers of --
ORRES; and --DOSU, which is a Variable Qualifier of --DOSE.
Classification Of Qualifier Variables
8. Example:
“Subject 101 had mild nausea starting on Study Day 6” is an
observation belonging to the Adverse Events domain in a clinical
trial.
The Topic variable value is the term for the adverse event,
“NAUSEA”
The Identifier variable is the subject identifier, “101”
The Timing variable is the study day of the start of the event,
which captures the information, “starting on Study Day 6”
Record Qualifier is the severity, the value for which is “MILD”
9. Observations about study subjects are normally collected for all subjects in a
series of domains. A domain is defined as a collection of logically related
observations with a common topic
Each domain dataset is distinguished by a unique, two-character code that
should be used consistently throughout the submission
This code, which is stored in the SDTM variable named DOMAIN, is used in four
ways: as the dataset name, the value of the DOMAIN variable in that dataset, as
a prefix for most variable names in that dataset, and as a value in the RDOMAIN
variable in relationship tables
All datasets are structured as flat files with rows representing observations and
columns representing variables. Each dataset is described by metadata
definitions that provide information about the variables used in the dataset
The metadata are described in a data definition document named “define” that
is submitted with the data to regulatory authorities
Domain
10. Define-XML specifies seven distinct metadata attributes to describe SDTM data:
• The Variable Name (limited to 8 characters for compatibility with the SAS
Transport format)
• A descriptive Variable Label, using up to 40 characters, which should be unique
for each variable in the dataset
• The data Type (e.g., whether the variable value is a character or numeric)
• The set of controlled terminology for the value or the presentation format of the
variable (Controlled Terms or Format)
• The Origin of each variable
• The Role of the variable, which determines how the variable is used in the
dataset. Roles include Identifiers, Topic, Timing, and the five types of Qualifiers.
• Comments or other relevant information about the variable or its data included
by the sponsor as necessary to communicate information about the variable or its
contents to a regulatory agency.
11. The majority of observations collected during a study can be divided among three
general observation classes: Interventions, Events, or Findings:
The Interventions class captures investigational, therapeutic and other treatments that
are administered to the subject (with some actual or expected physiological effect)
either as specified by the study protocol (e.g., “exposure”), coincident with the study
assessment period (e.g., “concomitant medications”), or other substances self-
administered by the subject (such as alcohol, tobacco, or caffeine)
Events class captures planned protocol milestones such as randomization and study
completion, and occurrences, conditions, or incidents independent of planned study
evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g.,
medical history).
Findings class captures the observations resulting from planned evaluations to address
specific tests or questions such as laboratory tests, ECG testing, and questions listed on
questionnaires. The Findings class also includes a sub-type “Findings About” which is
used to record findings related to observations in the Interventions or Events class.
General Observation Classes
12. In addition to the three general observation classes, a submission will generally
include a set of other special-purpose datasets of specific standardized structures to
represent additional important information. Examples include the following:
A Demographics special-purpose domain is included with human and animal
studies
Other special purpose domains such as Comments , Subject Elements ,Subject
Visits
Datasets to describe the design of a trial
Datasets to represent the relationships between datasets and records
Demographics Domain: Demographics is the parent domain for all other
observations for subjects, and should be identified with the domain code of “DM”.
The Demographics domain describes the essential characteristics of the study
subjects, and is used by reviewers for selecting subsets of subjects for analysis. The
Demographics domain, as with other datasets, includes Identifiers, a Topic variable,
Timing variables, and Qualifiers. Since DM has a fixed structure, only certain variables
may be added as appropriate.
13. Comments Domain: Comments are collected during the conduct of many
studies. These are normally supplied by a principal investigator, but might also
be collected from other sources such as central reviewers. When collected,
comments should be submitted in a single Comments domain
The Subject Elements Table:
The Subject Elements table describes the actual order of Elements that were
traversed by the subject, together with the start date/time and end date/time
for each Element. These correspond to the planned Elements described in the
Trial Elements of the Trial Design Model. Because actual data does not always
follow the plan, the model allows for descriptions of an unplanned Element for
subjects.
The Subject Visits Table:
The Subject Visits table describes the actual start and end date/time for each
visit of each individual subject. These correspond to the planned visits
described in the Trial Design Model Trial Visits table. Because actual data does
not always follow the plan, the model allows for descriptions of unplanned visits
for subjects.
16. The Trial Design Model (datasets)
The Trial Design Model defines a standard structure for representing the planned sequence of
events and the treatment plan for the trial. The model provides a standard way to define the
treatment groups and planned visits and assessments that will be experienced by trial subjects.
The model is built upon the concepts of Elements, Arms, Epochs, and Visits. The variables
corresponding to these concepts are used in many domains. The implementation guides define
specific details and examples for Trial Design.
Under the model, planned information is presented in a series of four tables:
• The Trial Elements table describes the Element code (unique for each Element), the Element
description, and the rules for starting and ending an Element. A rule could be expressed as
pseudo code or as executable code for determining transitions from one Element to another.
• The Trial Arms table describes each planned Arm in the trial. An Arm is described as an
ordered sequence of Elements, and the same Element may occur more than once in a given
Arm. In order to accommodate complex Trial Designs, this table allows for rules for branching
from one Element to another when a choice is available, and a rule for transitions to allow a
subject to either skip ahead to another Element rather than proceed linearly.
17. The Trial Visits table describes the planned order and number of visits in the
study. In the case when visits vary for each Arm, there would be a separate
record per Visit per Arm. It describes the allowable or planned values for VISIT,
VISITNUM and VISITDY in the trial (which are subsequently used as Timing
Variables for the collected study data), and rules for starting and ending each
visit. In most blinded trials, the timing of visits is the same for all subjects in all
Arms.
The Trial Sets table (TX) allows the submission of detailed information about
planned groups of subjects that result as a combination of experimental factors
of interest for a study (including experimental parameters, inherent
characteristics, and sponsor-defined attributes). A Set may be a planned
subdivision of a Trial Arm, or may consist of one or more Trial Arms. These
datasets are essential to determine whether data comparisons are feasible
across different studies.
18. Trial Inclusion/Exclusion Criteria
The Trial Inclusion Exclusion Domain (TI) contains one record for each of the
inclusion and exclusion criteria for the trial.
Trial Summary Information
The Trial Summary Information Domain (TS) contains one record for each trial
summary characteristic. Trial Summary is used to record basic information about the
trial, such as trial phase, protocol title and design objectives.
Trial Disease Assessments
The TD domain provides information on the planned protocol-specified disease
assessment schedule..
19. Trial Visits describes the
planned Visits for each Arm,
and any start and end rules.
Screen Run-In Drug A
Screen Run-In Drug B
Screening
Screen Run-In Placebo
Drug A
Drug B
Trial Arms
describes the
Elements in each
Arm, their order
and Epoch, and
any branching or
transition rules.
Screen Run-in Placebo
Drug A Drug B
Trial Elements describes the
Elements and the rules for
the start and end of each.
Placebo
Run-In Treatment
Epochs are described only in Trial
Arms, and have no separate table.
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5
20. There are many occasions when it is necessary or desirable to
represent relationships among datasets or records. The SDTM identifies
eight distinct types of relationships:
• A relationship between a group of records for a given subject within the
same dataset.
• A relationship between independent records (usually in separate
datasets) for a subject, such as a concomitant medication taken to treat
an adverse event.
• A relationship between two (or more) datasets where records of one
(or more) dataset(s) are related to record(s) in another dataset (or
datasets).
• A dependent relationship where data that cannot be represented by a
standard variable within a general-observation-class dataset record (or
records) can be related back to that record.
• A dependent relationship between a comment in the Comments
domain and a parent record (or records) in other datasets, such as a
comment recorded in association with an adverse event.
• A relationship between a subject and a pool of subjects.
Related Records Dataset
21. Supplemental Qualifiers Dataset
Pool Definition Dataset
This dataset identifies individual subjects included in a pool of
subjects for which a single observation record (pool level) is
captured.
Related Subjects Dataset
Some studies include subjects who are related to each other, and
in some cases it is important to record those relationships. Studies
in which pregnant women are treated and both the mother and her
child(ren) are study subjects are the most common case in which
relationships between subjects are collected. There are also
studies of genetically based diseases where subjects who are
related to each other are enrolled, and the relationships between
subjects are recorded.
Related Records Dataset
22. Overview:
The following standard domains, listed in alphabetical order by Domain
Code, with their respective domain codes have been defined or
referenced by the CDISC SDS Team in this document.
Special-Purpose Domains (defined in Section 5 – Models For
Special-Purpose Domains):
• Comments (CO) • Demographics (DM)
• Subject Elements (SE) • Subject Visits (SV)
Interventions General Observation Class (defined in Section 6.1 -
Interventions):
• Concomitant Medications (CM) • Exposure as Collected (EC)
• Exposure (EX) • Substance Use (SU)
• Procedures (PR)
Events General Observation Class (defined in Section 6.2 -
Events):
• Adverse Events (AE) • Clinical Events (CE) • Disposition (DS) •
Protocol Deviations (DV) • Healthcare Encounters (HO) • Medical
23. Findings General Observation Class (defined in Section 6.3 -
Findings):
• Drug Accountability (DA) • Death Details (DD) • ECG Test Results (EG)
• Inclusion/Exclusion Criterion Not Met (IE)
• Immunogenicity Specimen Assessments (IS)
• Laboratory Test Results (LB) • Microbiology Specimen (MB)
• Microscopic Findings (MI) • Morphology (MO)
• Microbiology Susceptibility Test (MS)
• PK Concentrations (PC) • PK Parameters (PP) • Physical Examination
(PE)
• Questionnaires (QS) • Reproductive System Findings (RP)
• Disease Response (RS) • Subject Characteristics (SC)
• Subject Status (SS) • Tumor Identification (TU) • Tumor Results (TR)
• Vital Signs (VS)
Findings About (defined in Section 6.4 - FA Domain)
• Findings About (FA)
• Skin Response (SR)
24. Trial Design Domains (defined in Section 7 - Trial Design
Datasets):
• Trial Arms (TA)
• Trial Disease Assessment (TD)
• Trial Elements (TE)
• Trial Visits (TV)
• Trial Inclusion/Exclusion Criteria (TI)
Relationship Datasets (defined in Section 8 - Representing
Relationships and Data):
• Supplemental Qualifiers (SUPP-- datasets)
• Related Records (RELREC)
A sponsor should only submit domain datasets that were actually
collected (or directly derived from the collected data) for a given
study. Decisions on what data to collect should be based on the
scientific objectives of the study, rather than the SDTM. Note that
any data that was collected and will be submitted in an analysis
25. Trial Elements (TE) dataset provides descriptions of the
building blocks that make up the study, including what event
indicates their start, what event indicates their end, and their
duration (if they have a fixed length).
Trial Arms (TA) dataset describes the planned treatment
paths (Arms) and the order of the Elements within each of
these
Trial Visits (TV) dataset describes the planned schedule of
Visits. Visits are defined as "clinical encounters" and are
described in the SDTM/SDTMIG using the timing variables,
VISITNUM, VISIT, and VISITDY.
Trial Inclusion/Exclusion (TI) describes the
inclusion/exclusion criteria used to screen subjects. Its
structure is one record per criteria per trial.
Trial Summary (TS) includes key details, called Parameters,
about the trial that would be useful in clinical trials registry.
26. 1. The Variable Name (limited to 8-characters for
compatibility with the SAS system V5 Transport format)
2. A descriptive Variable Label, using up to 40 characters,
which should be unique for each variable in the dataset
3. The data Type (e.g., whether the variable value is a
character or numeric)
4. The set of controlled terminology for the value or the
presentation format of the variable(Controlled Terms or
Format)
5. The Origin or source of each variable
6. The Role of the variable (Identifier, Topic, Timing, or the
five types of Qualifiers)
7. Comments or other relevant information about the
variable or its data 26
Submission metadata model uses seven
distinct metadata attributes
27. CDISC SDTM fundamental model
for organizing data collected in
clinical trials
Concept of Observations, which
consist of discrete pieces of
information collected during a
study described by a series of
named variables.
General Classes of Observations:
Events, Findings, Interventions
Variable Roles: determines the
type of information conveyed by
the variable about each distinct
observation: Topic variables,
Identifier variables, Timing
variables, Rule variables, and
Qualifiers (Grouping, Result,
Synonym, Record, Variable)
General principles and standards
CDISC SDTM Domains
SAS Dataset implementations
(dataset templates)
e.g. Vital Signs domains
Optimisations for Data Exchange per
study and for Medical Reviewers to
easier understand data
Specific principles and standards such
as ISO8601 for dates/timings, and both
Original & Standard values expected
Identifiers of records
per dataset and study
Decoded format, that is, the
textual interpretation of
whichever code was
selected from the code list.
29. The annotated CRF provides the migration team with a
clear presentation of SDTM variables
Completed following the GAP analysis and prior to
migration
Experience needed to create the annotated CRF
Knowledge of the SDTM Implementation Guide and
Metadata Submission Guidelines (chapter 4 – Guidelines
for Annotating CRFs)
Annotated CRF
30. Upon receiving all required information, start defining
mapping rules.
The mapping rules should be defined from source
datasets (raw data) to target datasets (SDTM)
Key components
SDTM standards and Controlled Terminology files
Study documents including original Annotated CRF
Standard template for specifications
Standard mapping rules to be used (e.g. ISO date
conversion, rename, derive etc.)
Specification
31. Adapt study terminology to standard CDISC (NCI) terminology
(CT)
The mapping needs to be described in the define.xml
CT not only restricted to only those values that are available in
the data
All entries capitalized for CDISC CT
‘Spelling’ as per external dictionary (e.g. MedDRA)
Controlled Terminology
Source CDISC/NCI CT
INFUSION PARENTERAL
Administration by injection, infusion, or implantation
MOUTH/THROAT ORAL
Administration to or by way of the mouth
TOPICAL-EYE OPHTHALMIC
TOPICAL PO TOPICAL
Mapping to CDISC (NCI) Controlled Terminology
e.g. Concomitant Medications route
32. SDRG provides FDA Reviewers with additional context for SDTM datasets
(regulatory submission).
The SDRG is intended to describe SDTM data submitted for an individual study in
the Module 5 clinical section of the eCTD.
The SDRG purposefully duplicates information found in other submission
documentation (e.g. the protocol, clinical study report, define.xml, etc.) in order to
provide FDA Reviewers with a single point of orientation to the SDTM datasets.
Study Data Reviewer’s Guide (SDRG)
Introduction
Protocol Description
Subject Data
Descriptions
Data Conformance
Summary
33. Sections of the reviewer’s guide
Introduction
Purpose This section states the purpose of the SDRG. The SDRG Template
includes standard text.
Acronyms Standard industry acronyms (e.g. MedDRA, LOINC, CDISC, SDTM,
ADaM, etc.) do not need to be documented (optional section)
Study Data Standards
code lists and
Dictionary Inventory
Controlled terminology version(s), and dictionary version(s) used in
the study
Protocol Description
Protocol Number
and Title
Protocol number or identifier, title, and versions included in the
submission
Protocol Design Visual representation or brief textual description of the protocol
design.
Trial Design
Datasets
Trial Design Datasets a list of variables is provided followed by a
explanation of the values assigned to the variables. Most of the
variables follow the sponsor controlled terminology.
34. Subject Data Description
Overview Summary orientation to the datasets containing subject data. study history or
timing, mapping of death information, reference start date etc.,
Annotated
CRFs
Description of notable annotation conventions,
Explanation of data that were not submitted
SDTM
Subject
Domains
overview of the subject-related SDTM domains AND Provide hyperlinks
List all subject-related datasets included in the submission alphabetically by
domain code.
Specify the functional category or categories for each domain.
Indicate if a Supplemental Qualifiers dataset is submitted for the domain
If relationships between the domain and other domains have been described
in RELREC, specify the related domains.
Specify the SDTM Observation Class
35.
36. Data Conformance Summary
Conformance
Inputs
• Reviewed every OpenCDISC findings: Errors, Warning, Info.
• Were sponsor-defined validation rules used to evaluate
conformance?
• Were the SDTM datasets evaluated in relation to define.xml?
Issues Summary summarizes findings from OpenCDISC validation rules and sponsor-
defined validation rules.
Additional
Conformance
Details
This section is not intended to contain the full OpenCDISC Details
report. Sponsors are discouraged from submitting the full report, but if
the sponsor considers it necessary, the full report may be submitted as
SDRG
37. Since becoming the recommended standard for the
submission of clinical and preclinical trial data to the FDA in
marketing applications, the SDTM has begun to be used by
sponsors for their upstream processing to support clinical
study reports and integrated reports.
As data is increasingly delivered to the FDA in the CDISC
standards, the FDA will be able to more efficiently review
individual submissions and do ad hoc analyses across
companies.
Conclusion