CDISC SDTM 3.3

SDTM : Study data tabulation model
Introduction to Clinical
1
Adverse event
2
SAE
3
ARM
4
Baseline
5
Randomization
6
Parallel
7
Crossover
8
DMC [Data Monitoring Committee ]
9
Eligible Criteria
10
Inclusion/Exclusion Criteria
11
Inform consent
12
Masking
13
Study Design
14
Study Documents
15
Study Start date
16
Study Type
17
Blinded Trails
ICH/GCP Guidelines
21 CRF Part 11
Clinical Research Methodology
1
Phase 1
2
Phase 2
3
Phase 3
4
Phase 4
aCRF Desigining
1
Rawdatasets
2
Blank CRF
3
SDTM Control Terminology Protocol
4
Blank Annotated aCRF
5
SDTM IG Guide
6
CDISC Annotation Rules
Trail Designing
Purpose of Trail designing
1
Clearly and quickly grasp the design of a clinical trial
2
Compare the designs of different trials
3
Search a data warehouse for clinical trials with certain features
4
Compare planned and actual treatments and visits for subjects in a clinical trial
TA :Trail Arm
1
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
1
describes the planned schedule of Visits
TI : Trial Inclusion/Exclusion Criteria
1
describes the inclusion/exclusion criteria used to screen subjects
TE : Trial Elements
1
describes the Elements used in the trial
Trial Summary
1
lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trials.
TD: Trial Disease Assessment
1
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
1
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
1
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
1
A special purpose domain that includes a set of essential standard variables that describe each subject in a Clinical study.
SV Subject Visits
1
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
1
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
1
An interventions domain that contains the details of a subject’s exposure to protocol-specified study treatment.
Models for Events Domains
AE Adverse Events
1
An events domain that contains data describing untoward medical occurrences in a patient…
DS Disposition
1
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
1
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
1
A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis.
Cardiovascular System Findings (CV)
1
A findings domain that contains physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic
Vital Signs
1
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
1
A Relating Peer Records domain that represents data of relationship records
Migration
1
A brief explanation of migration techniques in real world with unix commands via unix putty
Productivity Hacks to Get More Done in 2018
— 28 February 2017
- Facebook News Feed Eradicator (free chrome extension) Stay focused by removing your Facebook newsfeed and replacing it with an inspirational quote. Disable the tool anytime you want to see what friends are up to!
- Hide My Inbox (free chrome extension for Gmail) Stay focused by hiding your inbox. Click "show your inbox" at a scheduled time and batch processs everything one go.
- Habitica (free mobile + web app) Gamify your to do list. Treat your life like a game and earn gold goins for getting stuff done!