13 steps of clinical trial process
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Transcript of 13 steps of clinical trial process
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13 steps of Clinical Trial Process Vs Construction Process
Sada Shiva PrasadClinical Data Management
Sada Shiva Prasad
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Imagine, how good it would be if we could prepare a drug and sell it instantly, as below!!!!
Sada Shiva Prasad
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Clinical Trial Process simplified by comparing with Apartment Construction……Check out how!!!!
Sada Shiva Prasad
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STEP 1
Construction
Space for construction
Clinical Research
New Drug/Vaccine discovered by a Company
Sada Shiva Prasad
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STEP 2
Construction
Apartment Layout
Clinical Trial
Protocol
Sada Shiva Prasad
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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)
Sada Shiva Prasad
![Page 7: 13 steps of clinical trial process](https://reader033.fdocuments.us/reader033/viewer/2022051414/55a762661a28ab9b6a8b4755/html5/thumbnails/7.jpg)
STEP 4
Construction
Pillars and slab
Clinical Trial
Database design – visits, forms (paper/eCRF)
Sada Shiva Prasad
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STEP 5
Construction
Flats in a floor
Clinical Trial
Forms in a visit
Sada Shiva Prasad
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STEP 6
Construction
Increasing the Strength and quality of apartment
Clinical Trial
Design and program edit checks, QCA
Sada Shiva Prasad
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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)
Sada Shiva Prasad
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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.
Sada Shiva Prasad
![Page 12: 13 steps of clinical trial process](https://reader033.fdocuments.us/reader033/viewer/2022051414/55a762661a28ab9b6a8b4755/html5/thumbnails/12.jpg)
STEP 9
Construction
Any damages, repairs to the apartment including fire safety equipments.
Clinical Trial
Query resolution,
SAE reconciliation
Sada Shiva Prasad
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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
Sada Shiva Prasad
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STEP 11
Construction
Building evaluation and registration
Clinical Trial
FDA, EMEA, DCGI inspection and approval
Sada Shiva Prasad
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STEP 12
Construction
Publicity (brochures, ads, campaigns etc.)
Clinical Trial
Publication writing
Sada Shiva Prasad
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STEP 13
Construction
Painting and Interior design
Clinical Trial
Packaging and labeling
Sada Shiva Prasad
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Appreciate your feedback and questions !!
Sada Shiva Prasad
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Sada Shiva Prasad