CDISC SDTM 3.3

Teacher

maziworld

Category:

CDISC

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What is SDTM?

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process.

Highlights of SDTM :

SDTM Domains
aCRF Desigining
Trail Desigining
Spec Desigining
SDTM Conversions
Validation
Migration
Submission

Software Installation : Currently software installation is a paid one. You need to do it from system administrator. The total software which consists of around 17 Gb. It will take 2 Hours to do the installation. For SDTM there is no software you need use SAS for SDTM Programming.

System requirements :

Processor : i3 and above

RAM : 4GB and above [preferable 8 GB Best ]

Harddisk : SSD Harddisk with 250 GB OR Above / other harddisk also its ok

Target Audience : To do these SDTM Course you need have the knowledge on

Base sas
Advanced SAS
Clinical Reseach just basic knowlegde

Materials : Books and Daily notes will be provided by us along with that recording also will be provided for reference . Step by step notes will be provided and excersises also.

Sample Videos : We request you that first don’t join the course directly as we provide the sample videos in the cirriculam first watch that try to understand. If you understand and feel comfortable with trainer explanation then gohead for classes. Join the course.

Working hours : 9:00 am ist to 8 pm ist .

SDTM : Study data tabulation model

Introduction to Clinical

Adverse event

SAE

ARM

Baseline

Randomization

Parallel

Crossover

DMC [Data Monitoring Committee ]

Eligible Criteria

Inclusion/Exclusion Criteria

Inform consent

Masking

Study Design

Study Documents

Study Start date

Study Type

Blinded Trails

ICH/GCP Guidelines

21 CRF Part 11

Clinical Research Methodology

Phase 1

Phase 2

Phase 3

Phase 4

aCRF Desigining

Rawdatasets

Blank CRF

SDTM Control Terminology Protocol

Blank Annotated aCRF

SDTM IG Guide

CDISC Annotation Rules

Trail Designing

Purpose of Trail designing

Clearly and quickly grasp the design of a clinical trial

Compare the designs of different trials

Search a data warehouse for clinical trials with certain features

Compare planned and actual treatments and visits for subjects in a clinical trial

TA :Trail Arm

describes the sequences of Elements in each Epoch for each Arm, and thus describes the complete sequence of Elements in each Arm

TV : Trial Visits

describes the planned schedule of Visits

TI : Trial Inclusion/Exclusion Criteria

describes the inclusion/exclusion criteria used to screen subjects

TE : Trial Elements

describes the Elements used in the trial

Trial Summary

lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trials.

TD: Trial Disease Assessment

provides information on the protocol-specified disease assessment schedule, and will be used for comparison with the actual occurrence of the efficacy assessments in order to determine whether there was good compliance with the schedule.

TM: Trial Disease Milestones

describes observations or activities identified for the trial which are anticipated to occur in the course of the disease under study and which trigger the collection of data.

Spec Designing

An SDTM Spec designing will be explained based on aCRF designing and docs

SDTM Domain in-depth domain explanation and programming conversion Techniques

Models for Special Purpose Domains

DM Demographics

A special purpose domain that includes a set of essential standard variables that describe each subject in a Clinical study.

SV Subject Visits

A special purpose domain that contains the actual start and end data/time for each visit of each individual subject.

Models for Interventions Domains

CM Concomitant and Prior Medications

An interventions domain that contains concomitant and prior medications used by the subject, such as those given on an as needed basis or condition-appropriate medications

EX Exposure

An interventions domain that contains the details of a subject’s exposure to protocol-specified study treatment.

Models for Events Domains

AE Adverse Events

An events domain that contains data describing untoward medical occurrences in a patient…

DS Disposition

An events domain that contains information encompassing and representing data related to subject disposition

Findings About Events or Interventions

Findings About Events or Interventions FA

A findings domain that contains the findings about an event or intervention that cannot be represented within an events or interventions domain record or as a supplemental qualifier.

Models for Findings Domains

LB Laboratory Test Results

A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis.

Cardiovascular System Findings (CV)

A findings domain that contains physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic

Vital Signs

A findings domain that contains measurements including but not limited to blood pressure, temperature,respiration, body surface area, body mass index, height and weight.

RELREC Dataset

A Relating Peer Records domain that represents data of relationship records

Migration

A brief explanation of migration techniques in real world with unix commands via unix putty

FAQ 1

Faq Content 1

FAQ 2

Faq Content 2

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