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

1

Phase 1

2

Phase 2

3

Phase 3

4

Phase 4

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