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

Title

18

Blinded Trails

1

Phase 1

2

Phase 2

3

Phase 3

4

Phase 4

1

Rawdatasets

2

Blank CRF

3

SDTM Control Terminology Protocol

4

Blank Annotated aCRF

5

SDTM IG Guide

6

CDISC Annotation Rules.

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

1

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

1

describes the planned schedule of Visits

1

describes the inclusion/exclusion criteria used to screen subjects

1

describes the Elements used in the trial

1

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

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.

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.

1

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

1

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

1

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

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

1

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

1

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

1

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

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.

1

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

1

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

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.

1

A Relating Peer Records domain that represents data of relationship records.

1

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

1

ADaM Variable Conventions

2

General Variable Conventions

3

Timing Variable Conventions

4

Date and Time Imputation Flag Variables

5

Flag Variable Conventions

6

Variable Naming Fragments

1

ADSL Identifier Variables

2

Subject Demographics Variables

3

ADSL Population Indicator Variables

4

ADSL Treatment Variables

5

ADSL Dose Variables

6

Treatment Timing Variables

7

Subject-Level Period, Subperiod, and Phase Timing Variables

8

ADSL Subject-Level Trial Experience Variables

9

More concepts on Extra variables

1

Working with ADAE Conversions with additional variables

2

Working with ADDS Conversions with additional variables

3

Working with ADCM Conversions with additional variables

4

Working with ADEX Conversions with additional variables

1

1.Identifier Variables for BDS Datasets

2

2. Record-Level Treatment and Dose Variables for BDS Datasets

3

Record-Level Dose Variables for BDS Datasets

4

Timing Variables for BDS Datasets

5

Period, Subperiod, and Phase Start and End Timing Variables

6

Suffixes for User-Defined Timing Variables in BDS Datasets

7

Analysis Parameter Variables for BDS Datasets

8

PARAM, AVAL, and AVALC

9

Analysis Parameter Criteria Variables for BDS Datasets

10

Analysis Descriptor Variables for BDS Datasets

11

Analysis Visit Windowing Variables for BDS Datasets

12

Time-to-Event Variables for BDS Datasets

13

Toxicity and Range Variables for BDS Datasets

14

Flag Variables for BDS Datasets

15

BDS Population Indicators

16

Datapoint Traceability Variables

17

SDTM and ADaM Population and Baseline Flags diference

18

Creation of Derived Columns versus Creation of Derived Rows

19

Rules for the Creation of Rows and Columns

1

Working with ADVS Conversion with additional Variables

2

Working with ADLB Conversion with additional variables

3

Working with ADTTE Conversion with additional Variables

1

A parameter-invariant function of AVAL and BASE on the same row that does not involve a transform of BASE should be added as a new column.

2

Creation of a New Parameter to Handle a Transformation

3

Creation of a New Parameter to Handle a Second System of Units

4

Creation of a New Row to Handle a Derived Analysis Timepoint

5

Creation of New Rows to Handle a Derived Analysis Timepoint When There is Value-Level Population Flagging

6

Creation of New Rows to Handle Imputation of Missing Values by Last Observation Carried Forward and Worst Observation Carried Forward

7

Creation of New Rows to Handle Imputation of Missing Values by Baseline Observation Carried Forward and Last Observation Carried Forward

8

Creation of Endpoint Rows to Facilitate Analysis of a Crossover Design

1

Paired lab variables

2

Lab visit window techniques

3

Raw/Standard Names/Units

4

ADaM – DTYPE

5

ADAM Metadata Excel file

6

ISO8601 Dates, Partial Dates, Durations and Periods

7

Study Validation Checklists

8

Baseline Values

9

Change, Percent Change from Baseline Imputation Methods

1

Demographics and Baseline Characteristics safety population

2

Ae listing of treatment emergent adverse event

3

Subject Disposition

4

Vital Signs Safety Population

5

Exposure to Study Medication Safety Population

1

Demographic: Subject Demographics and Baseline Characteristics Safety Population

2

Adverse event

3

Summary of Overall Treatment Emergent Adverse Event (TEAE) Information Safety Population

4

Summary of Treatment Emergent Adverse Events (TEAE) by System Organ Class and Preferred Term Safety Population

5

Concomitant medication: Concomitant Treatment Phase Medications Safety Population

6

Exposure: Exposure to Study Medication Safety Population

7

Laboratory: Laboratory shift table

8

Vitals: Summary of Change from Baseline in Vital Signs Safety Population

9

Disposition: Subject Disposition.

1

Summary of Treatment-Emergent Adverse Events by Maximum CTCAE Grade

2

Summary of vitals sign safety population

3

Coagulation values by (mean of +/- ) values by visit

4

Kaplan-meier plot of time to first abnormal laboratory test values

5

% change in tumor size from baseline