13 steps of Clinical Trial Process Vs Construction Process

Sada Shiva PrasadClinical Data Management

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Imagine, how good it would be if we could prepare a drug and sell it instantly, as below!!!!

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Clinical Trial Process simplified by comparing with Apartment Construction……Check out how!!!!

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STEP 1

Construction

Space for construction

Clinical Research

New Drug/Vaccine discovered by a Company

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STEP 2

Construction

Apartment Layout

Clinical Trial

Protocol

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STEP 3

Construction

Machines used (Cranes, concrete mixers, tractors etc.)

Clinical Trial

Specifications for form designing, rules programming etc. (The Data Management Plan)

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STEP 4

Construction

Pillars and slab

Clinical Trial

Database design – visits, forms (paper/eCRF)

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STEP 5

Construction

Flats in a floor

Clinical Trial

Forms in a visit

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STEP 6

Construction

Increasing the Strength and quality of apartment

Clinical Trial

Design and program edit checks, QCA

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STEP 7

Construction

Bricks, concrete, tiles etc used for constructing walls

Clinical Trial

Tracking and Collection of Subject Data forms(paper CRFs)/ subject data in the database (EDC)

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STEP 8

Construction

Constructing walls by using bricks, cement, tools etc..

Clinical Trial

Data integration across clinical database and external databases.

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STEP 9

Construction

Any damages, repairs to the apartment including fire safety equipments.

Clinical Trial

Query resolution,

SAE reconciliation

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STEP 10

Construction

Internal evaluation of the apartment

Clinical Trial

Medical writing Reports (SAS datasets in SDTM format) for Regulatory submission

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STEP 11

Construction

Building evaluation and registration

Clinical Trial

FDA, EMEA, DCGI inspection and approval

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STEP 12

Construction

Publicity (brochures, ads, campaigns etc.)

Clinical Trial

Publication writing

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STEP 13

Construction

Painting and Interior design

Clinical Trial

Packaging and labeling

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Appreciate your feedback and questions !!

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Sada Shiva Prasad